February 2011 Supplement to appliedclinicaltrialsonline.com eClinical

Collaboration Challenge

Integrated Technology

Manage Trial Master Files via Investigative Portals

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Look for PAREXEL at: CHI Patient Recruitment Phase I Clinical Trials Clinical Trial Supply Europe in Clinical Trials London, UK Barcelona, Spain -IAMI &, &EBn  &EBn  &EBn  From the Publisher Recently, considerable advancements have been made in the eClinical trials area, espe- cially regarding integrated technology and eTMF solutions via investigative portals. The eClinical Trials supplement features ar- ticles on various aspects of clinical trials tech- nology, as well as our eClinical Trials Directory, where you can find up-to-date contact information on the industry’s vendors.

Kind regards,

Contents

Wayne K. Blow 6 Collaboration Challenge Publisher, Applied Clinical Trials The seven elements of an integrated clinical collaboration platform. APPLIED Chet Shemanski CLINICAL TRIALS

12 Integrated Technology FEBRUARY 2011 SUPPLEMENT STAFF Building a technology foundation to support Editorial Offices clinical development efficiency. 485 Route 1 South, Building F, First Floor, Iselin, NJ 08830 USA +1 (732) 346-3080 fax: +1 (732) 596-0003, www.actmagazine.com Bill Byrom EDITOR-IN-CHIEF Lisa Henderson, [email protected] MANAGING EDITOR Timothy Denman, [email protected] ASSISTANT EDITOR Kayda Norman, [email protected] 18 Manage Trial Master Files via ART DIRECTOR Dan Ward, [email protected] Investigative Portals EUROPEAN EDITOR Philip Ward, [email protected] Automated eTMF solutions reduce costs, improve Sales Offices productivity, and enhance data management. PUBLISHER AND EUROPEAN SALES Wayne K. Blow Vito Anthony Losito and Rodd Schlerf 485 Route 1 South, Building F, First Floor, Iselin, NJ 08830 USA +1 (732) 346-3021 fax: +1 (732) 596-0240 UK: +44 1925 732 797 fax: +44 1925 732 798, [email protected] ADMINISTRATIVE ASSISTANT Daisy Roman-Torres 22 eClinical Trials Directory +1 (212) 951-6794 fax: +1 (212) 951-6604, [email protected] A listing of eClinical providers complete with WESTERN SALES MANAGER John Kiesewetter addresses and contact details. PO Box 71275, Eugene, OR 97401 USA +1 (541) 338-0022 fax: +1 (541) 338-0044, [email protected] EAST COAST SALES EXECUTIVE Hope Corcoran +1 (732) 346-3043 fax: +1 (732) 596-0240, [email protected] ADVERTISING SALES COORDINATOR Joanne Capone +1 (732) 346-3031 fax: +1 (732) 596-0012 Production Offices PRODUCTION MANAGER Terri Johnstone Advanstar Communications, 131 W. 1st Street, Duluth, MN 55802 USA +1 (218) 740-7259 fax: +1 (218) 740-7223. All color separations, proofs, and film produced by Advanstar’s Scanning and Digital Prepress Departments.

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4 APPLIED CLINICAL TRIALS SUPPLEMENT appliedclinicaltrialsonline.com February 2011 organically grown

Many patients Many researchers Many tests Many processes Many years

One platform. Growing with your dynamic clinical development.

Technology for a healthy world.® www.mdsol.com 1.212.918.1847

Clinical Portal ƭ Protocol Development ƭ Trial Planning ƭ Data Capture ƭ Monitoring ƭ SAE Capture ƭ Data Management ƭ Trial Management eClinical TRIALS

Chet Shemanski

Workspace Self Profisioning Registration Collaboration Portal eTMF Challenge Alerts & Content Notifications Management

Workflow The seven elements of an integrated clinical collaboration platform. CHET SHEMANSKI

he estimated cost of running a clini- the effective management and exchange of study cal trial in the United States ranges documentation can have a significant impact on from $20 million for a Phase I trial, the cost and time to complete a clinical trial. Tto $100 million for a Phase III trial. Yet despite the costs in time, effort, and Sponsors can invest significant dollars money, the trial master file (TMF) is often still to improve the efficiency and reduce the costs managed through a combination of paper and associated with running trials. Site efficiency simple shared folders, scattered across many and productivity can be improved by central- locations in various countries. Management of izing information, providing recruitment and a paper TMF can be resource intensive–docu- screening tools, automating scheduling, manag- ments are handled by multiple people from col- ing finances, and providing accurate reporting lection at the investigational site to placement in and metrics. Historically, suppliers of electronic regulatory binders. TMF documents are tracked data capture (EDC) and clinical trial manage- manually using spreadsheets or checklists that ment systems (CTMS) have focused explicitly provide little visibility into what has been col- and exclusively on managing the data involved in lected to date and what is missing. Often, dupli- clinical trials. The problem is, however, that the cate copies are collected and filed unnecessarily data is only part of the equation. Equally impor- while others expire or go uncollected. The result tant are the documents, dates, notifications, and is decreased operational efficiency, higher costs, other elements of collaboration. and the risk of regulatory non-compliance, and Management of essential trial documentation possibly approval delays. is, indisputably, one of the most time consuming and costly activities associated with conducting Need for collaboration a clinical trial. ICH E6 guidance on Good Clini- Collaboration is defined as the ability for indi- cal Practice (GCP) specifies an inventory of over viduals and teams to work together in an ef- 200 discrete documents that must be managed fective and efficient manner. There are many before, during, and after the trial. Any or all of barriers to collaborative management of clinical these documents must be available for audit by trial documentation including: the lack of a cen- the sponsor and for inspection by the regulatory tralized, globally accessible platform to manage authorities, and considering the massive vol- and store essential study documentation; incon- umes of documentation involved in the process, sistent document management processes across

6 APPLIED CLINICAL TRIALS SUPPLEMENT appliedclinicaltrialsonline.com February 2011 eClinical TRIALS

the organization and between organizations; inconsistent or incomplete work assignments; inefficient notification Globalization, specialization, and of key events requiring follow-on action; and incomplete, missing, expired, or redundant documentation, outsourcing are changing the way Removing these barriers is an important part of estab- clinical trials are conducted. lishing an environment that fosters collaboration among all constituencies involved in managing clinical trial documen- oncology vs. CNS, Phase I vs. Phase III, etc. Once the tation—keeping them connected, informed, and on task by characteristics of a trial are defined and the appropriate providing access to everyone at any time, from anywhere. template selected, the provisioning of the workspace is au- Internet portals that allow stakeholders to access trial tomated using an electronic workflow. information and monitor overall trial progress are often viewed as a solution to the collaboration challenge—and Element 2: self registration are often accompanied by claims of increased productivity Factors such as globalization, specialization, and outsourc- and decreased trial costs. However, portal solutions can ing are changing the way clinical trials are conducted. The fall short because they present information from diverse industry is moving from a purely transactional environment sources in a unified way and may not be well integrated to one where collaboration is much more important. In with the underlying processes that create, manage, and dis- order to support this transformation, corporate IT is being seminate that information. This is addressed in the model asked to open up the network firewall to support extranet of an integrated clinical collaboration platform. collaboration (i.e., collaboration with individuals outside the organization). The administrative workload of main- The integrated clinical collaboration platform taining external user accounts, in addition to internal user An integrated collaboration platform is a unified collec- accounts, prohibits many organizations from establishing tion of seven discrete components that, in combination, this type of collaborative environment. can provide an environment where diverse constituents Extranet access poses a unique set of challenges that can participate in the creation and management of clini- must be addressed in the integrated collaboration platform: cal trial documentation in real time. Each component, by • How can I automate and manage the process of external itself, has intrinsic value—but the combination of the seven user account requests and account provisioning? components in an integrated platform creates a system that • How can I keep external user account information (e.g., connects trial participants and supports collaborative docu- username and password) segregated from internal user ment creation, review, approval, and ongoing management. account information? • How can I relate external user account provisioning to Element 1: workspace provisioning key prerequisite tasks such as accepting a privacy state- At any given time, a pharmaceutical company can be ac- ment or signing a confidentiality agreement? tively engaged in hundreds of clinical trials. Imagine the ef- • How can external users perform their own password fort and overhead involved with provisioning collaboration changes? websites to support that volume of work using traditional Automating the user account provisioning process elimi- web development methods. Considerations include ensur- nates the need for corporate IT intervention and improves ing consistent adherence to established corporate branding the efficiency of opening the clinical collaboration environ- standards; corporate and regulatory standards; a process ment to extranet users. This automation is accomplished that is repeatable; and computer system validation tasks as- through a workflow that routes extranet user self-registra- sociated with regulated systems. These considerations can tion requests to the Clinical Program Manager for review, be streamlined for the use of workspace templates. credential verification, and approval. Once the request is Workspace templates quickly create collaboration web- approved, the workflow sends an e-mail to the registrant sites and basic content. Any number of new websites (or containing a link to the collaboration workspace, a system workspaces) can be generated from a template, which is a generated username, and a temporary password. When the set of content pages and schemas (which are themselves extranet user logs in for the first time, they are re-directed stored on the web server as a set of HTML and XML files). to an area of the workspace where they must first complete A workspace template contains specific design information the prerequisite tasks and change their password before about a website, including the lists that are part of that web- gaining complete access. Through automation, the admin- site, web parts used in the website, the website’s themes istrative burden typically associated with workspace cre- and borders, and navigation, as well as some content (such ation and external user account provisioning by corporate as document libraries). Different workspace templates can IT is eliminated and another barrier to effective clinical be defined for different types of trials—drug vs. vaccine, trial collaboration is removed.

February 2011 appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS SUPPLEMENT 7 eClinical TRIALS

meet specific needs, and is more than a just an electronic An eTMF collects essential trial filing cabinet. documents and makes them available Element 4: managing clinical content to disparate constituencies. Many drug sponsors rely solely on shared drives and e- mail as the primary mechanisms for storing and sharing Element 3: the electronic trial master file essential trial documentation. While these solutions can All companies in the pharmaceutical industry must main- work somewhat effectively when dealing with moderate tain a TMF for each clinical trial they sponsor. Even though volumes of documents, they cannot scale to meet the regulatory guidance (such as ICH E6) exists, there is no complexity of large global clinical trials. In today’s world, comprehensive common model for managing those docu- the volume of clinical trial documentation is growing, ments. Typically, a company is left to interpret the guidance not shrinking—resulting in increased management costs and develop a unique TMF management strategy—one and the need to disseminate important information both based on institutional knowledge, past experience, and quickly and efficiently. opinion. This is a highly inefficient way for an industry to Enterprise document management systems (EDMS) operate for many reasons: can provide significant advantages in managing the eTMF • All drug development companies and contract research as they address every stage of the document lifecycle— organizations (CROs) spend considerable resources from initial creation through review and approval. Although defining and redefining the content of the trial master many commercial document management solutions provide file for each clinical trial. comprehensive lifecycle management, few companies may • The relative burden on smaller companies that have be able to take full advantage of that function because the limited TMF management expertise and limited lifecycle management process requires collaboration to ex- financial resources is very high. tend document management solutions outside the firewall. • Records and information exchange between collaborating These solutions can be viewed as being complex, clumsy, companies can be cumbersome and at times may inhibit and not well integrated with common productivity tools such or prevent cross-licensing or joint ventures. as e-mail, task lists, and calendars. In many organizations, • Inconsistent terminology and file structure from the electronic management of a document only occurs once sponsor to sponsor wastes time and makes sponsor it becomes final and is marked as record—rendering the audits less efficient. EDMS as nothing more than a very expensive shared drive. In 2009, the Drug Information Association (DIA) em- The clinical collaboration workspace simplifies the man- barked upon an effort to define a standard taxonomy for agement of essential trial documentation by effectively clinical trial master files for use by the industry. This col- integrating document management processes with the way laborative effort involved over 120 representatives from 87 people work on a daily basis. Workflows, not people, drive biopharmaceutical companies, contract research organi- the creation of many documents. For example, at the start zations, consultancies, technical vendors, and regulatory of a trial, when a principal investigator is granted access to agencies and resulted in the definition of the DIA TMF the workspace, the system automatically generates an FDA Reference Model. 1572 Statement of Investigator form, pre-populated with the An electronic trial master file (eTMF) collects essen- investigator’s demographic information, and e-mails a link tial trial documents electronically in a central location to the investigator for final completion and sign-off. Once and makes them available to disparate constituencies, via this is complete, a work item is sent to a Clinical Research the Internet, from any location at any time. As the indus- Associate (CRA) for a final QC check of the submitted form try moves toward larger, more complex, global clinical and electronic approval. If the investigator fails to complete trials, an eTMF becomes even more important. The ben- the task within a specified amount of time, the system can efits of using an eTMF include streamlined processes, in- send them a reminder e-mail as well as a notification to the creased transparency, simplified tracking, and enhanced CRA that a follow-up telephone call might be in order. security. To get the maximum return on an eTMF, includ- ing significant cost savings, it has to be considered as Element 5: workflows—managing clinical tasks a management tool rather than just an electronic docu- Getting work done on a day-to-day basis frequently re- ment repository. With that said, a good eTMF is based on quires information from or tasks to be performed by other industry guidance (such as the DIA Reference Model), people. Options to communicate these needs include e- includes a comprehensive document inventory, provides mail, phone calls, and in-person discussions, but often it’s metadata requirements, organizes content logically, uses difficult to get people to respond to these communications standard nomenclature, may be used “as-is” or adapted to or directives in a timely manner (or at all). Many work

8 APPLIED CLINICAL TRIALS SUPPLEMENT appliedclinicaltrialsonline.com February 2011 'SQTVIWWWXYH]XMQIPMRIW 6IHYGIWXYH]GSWXW -QTVSZIWXYH]JIEWMFMPMX]

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items are dependent on the completion of preceding work that requires the investigator to open the document and items and failure to complete them on time hinders pro- then acknowledge that the document was read—the elec- ductivity and decreases efficiency. Within the context of tronic equivalent of a protocol signature page. In a similar a collaborative clinical trial, a standard work item inven- situation, when an expedited safety report is created by the tory defines what work needs to be done, when the work pharmacovigilance group, a notification is automatically needs to be done, and who is responsible for completing the sent to all of the principal investigators that are participat- work. It also facilitates the tracking and reporting of what ing in clinical trials for the drug(s) referenced in the report. is expected and what is missing from the project. Often, a However, since there is no regulatory requirement for the completed work item or a group of completed work items investigator to acknowledge reading the report, the notifi- may trigger other events (e.g., send a notification to ship cation e-mail only includes a link to the document and not product) which eliminates unnecessary delays. the electronic acknowledgement task. All work items in the inventory should be standard, Notifications can also be used to inform people of up- meaning no “ad hoc” activities exist. Work items can be coming events, of key milestones that have been reached, planned or spontaneous. For example, the creation of the or as reminders for upcoming or past due obligations. They FDA 1572 form is a planned item while the creation of a Se- can also be used as escalation vehicles on the same past rious Adverse Event report is a spontaneous item. In either due obligations. The alerts and notifications that are sent case, once these documents are created, the management should contain standard text and formatting and should of the remaining lifecycle stages is automated using elec- include visual clues regarding the subject and importance tronic workflows. These workflows implement standard level of the communication. Depending on local privacy business processes and enforce consistency by assigning laws, it may be necessary to include an “opt out” for certain tasks to the appropriate people at the appropriate time. By types of communications. allowing people to concentrate on performing the work at hand, and not “what happens next,” variability is removed from the process, which leads to improved operational ef- Communicating critical information to ficiency and enhanced productivity. global collaborators in a timely way Besides standardizing business processes, workflows also provide several other benefits including real-time vis- reduces operational costs and delays. ibility into the process, delegation of work items, assign- ment of work items to members of a group instead of an Element 7: the study portal individual, escalation of incomplete work items, automation Look up the definition of the word portal and you will find of rote tasks, and notifying stakeholders of completed work some very interesting results. In architecture, a portal and key events. is defined as a gate, doorway, or tunnel. In fiction, it is defined as a magical or technological doorway that con- Element 6: alerts and notifications nects two different locations in time or space. And finally, The ability to communicate critical clinical information to in technology, it is defined as a website that functions as a global collaborators in a timely way can reduce operational single point of access to information on the Internet. If you costs and delays through the elimination of postal delivery, further refine the search and look up the term Internet por- overnight couriers, and fax machines. As mentioned previ- tal, the picture becomes pretty clear—an Internet portal ously, the integrated collaborative clinical platform makes presents information from diverse sources in a unified way; extensive use of electronic workflows for things like work- providing a way for enterprises to present a consistent look space creation, user account provisioning, document cre- and feel with access control and procedures for multiple ap- ation, and document lifecycle management. A key aspect of plications and databases, which otherwise would have been electronic workflow is the inclusion of automated alerts and different entities altogether. notifications. Both alerts and notifications are used to keep Internet portals have been used in the life sciences those involved with the collaborative process abreast of what industry for most of the past decade, however the wide- is happening on the trial. Both typically leverage e-mail or spread adoption of the investigator portal concept has SMS technology to communicate with the recipient. Alerts been slow. Like most new, transformational technologies however, require the recipient to complete a reciprocal ac- used in clinical trials (such as electronic data capture), tion while notifications are usually informational in nature. investigator portals are plagued with the reputation of For example, when the clinical protocol is amended, an being unintuitive, cumbersome, and difficult to master. alert is automatically sent out to all active principal inves- Clinical investigators and their supporting site personnel tigators working on the trial to inform them of the new are usually quite comfortable with their existing processes amended protocol. The alert includes a link to a work item and manual workflows—regardless of how inefficient or

10 APPLIED CLINICAL TRIALS SUPPLEMENT appliedclinicaltrialsonline.com February 2011 eClinical TRIALS

error-prone they might be. It is a simple case of the “devil Summary that you know.” It is clear and widely accepted that the cost of clinical When designing an investigator portal to support key ac- trials continues to escalate and increased operational ef- tivities such as study start-up and document exchange, there ficiency is a key component of cost control/reduction and are many things to consider. First and foremost, keep the de- the speed of the trials. Most software investments focus on sign simple. It is critical that the portal is visually attractive managing the data involved in clinical trials, but ignore the and easy to use. A simple and streamlined user interface that documents, despite the massive costs and time involved in requires one or two mouse clicks to navigate is much easier creating and managing that content. Even today, most clini- to learn (and remember) than one that is overly complex and cal trials continue to be paper-based and are supported by appears busy. The investigator should be presented with a manual document management processes. The eTMF is at dashboard-like overview of key trial metrics, current work the heart of a clinical collaboration portal. When combined items, and important communications upon log in. Less with the other six elements—standard work item invento- frequently accessed information can be presented on subse- ries; self registration; complete and compliant document quent pages that can be accessed quickly and easily. management; automated workflows; alerts and notifica- Next, it is very important to provide a comprehensive tions; and a portal that connects the collaborators—the training session on the use of the portal. This usually can result is an integrated platform that can dramatically re- be accomplished in a few-hours during the study start-up duce the time and effort involved in creating and managing meeting. Alternatively a link to an online training video documents. The result is a similarly dramatic reduction in can be included in the portal so that it can be viewed again costs and complexity. if a refresher is needed. Once training is completed it is important to provide the users with the ability to access a Chet Shemanski is Director, Product Management, at Next- frequently asked questions (FAQ) page—this is especially Docs Corporation, King of Prussia, PA, e-mail: cshemanski@ important for casual users of the portal. nextdocs.com.

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February 2011 appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS SUPPLEMENT 11 eClinical TRIALS

Bill Byrom Integrated Technology

Building a technology foundation to support clinical development efficiency.

TOM GRILL/GETTY IMAGES

t is clear that standalone systems to facilitate Data integration. Ensuring that key data are trials do not interoperate sufficiently to maxi- shared by appropriate applications—eliminating mally leverage technology. The challenge duplication of tasks and associated data recon- Ithen is to achieve an integrated solution with ciliation activities. the next generation of technologies that are Convergence of technologies. Blurring aligned to accelerate development. This article the boundaries between applications by mak- considers the eClinical technology foundation re- ing functions contained within one technology quired to bring greater efficiency and productivity product efficiently accessed via another. Conver- to clinical development. To explore this, we need gence goes beyond data integration to making to agree upon a definition of what eClinical is. workflow simpler and more efficient and intui- eClinical means more than simply a clinical trial tive for users. technology, such as an electronic data capture Data consolidation for decision making. (EDC) system, but a combination of technologies Enabling users to access data that is extracted that form an integrated solution. This integra- from multiple technology solutions and pre- tion should focus not simply on sharing data, but sented together to aid their ability to understand around simplifying the way individual applications trial progress and data. operate together to smooth the workflow and ac- A common technology suite. Having a com- cess to information for the key technology end mon navigation and look-and-feel for a collection users: site personnel, study managers, study moni- of technologies to simplify training and usability. tors, clinical supplies teams, senior management, Integrated service delivery. Providing inte- regulatory, and pharmacovigilance teams. This grated project management and support when changes our attention from purely data integra- an integrated combination of technologies is tion, to explore how end user workflow and pro- deployed. cesses can be operated seamlessly when multiple This article will explore some of the key com- technology solutions such as EDC, clinical trial ponents of the technology platform that are re- management systems (CTMS), and randomization quired to deliver this vision of eClinical: a clinical and trial supply management (RTSM)—typically technology integration platform (CTIP), identity delivered using IVR/IWR technology—systems management solution and portal technology, and are in use together. Five objectives underpin the an enterprise reporting application with asso- effective delivery of this definition of eClinical: ciated information architecture. This platform

12 APPLIED CLINICAL TRIALS SUPPLEMENT appliedclinicaltrialsonline.com February 2011 eClinical TRIALS

eClinical Portal: Dashboard Component the interactions between the systems, catalogs the data each system contains, and keeps track of what information

Country Subjects each systems “needs” from the others. With a full audit CRFs 2 Date of FSFC: 16 Mar 2010 240 Partial 817 Completed 2465 trail and an activity monitor, this component of the eClini-

Expected 950 2 200 DCFs cal platform provides full visibility of all the integrations Active Approved Planned 160 Open 1087 Sites Answered 216 and processes through a single interface, increasing the Closed 1563 120 14 16 SDV ability to support a high number of integrated technologies 80 Changed 1153

Completed 1245 6 across a large number of studies. Expected 1788 Active Approved Planned 40 Supplies ePRO In its simplest form, this approach achieves the same 0 0 0 0 0 0 0 0 0 Compliance (%) 97.14 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 1 1 1 1 10 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 010 010 010 010 010 010 010 010 010 0 0 0 0 0 0 0 0 0 010 010 010 010 2 2 2010 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2010201020102 2 2 r 2 r 2 r 2 2 r 2 2 r 2 r 2 r 2 r 2 r 2 r 2 r 2 r 2 r 2 r 2 r 2 t t t t v v v v v v v a a a ar a ar p p p p p p p p p p p n n n n p o o o o o o o A A A A A A A A A A A Ju Ju Ju Ju Se Oc Oc Oc Oc M M M M M M 2 6 8 2 4 6 0 2 7 9 0 2 4 8 0 0 4 8 9 8 N N N N N N N 7 9 3 5 9 1 0 0 0 1 1 1 2 2 2 2 3 5 May7 May1 May3 May7 May9 May1 May5 May7 May1 May0 0 0 1 3 0 0 1 2 3 8 2 8 2 4 0 111 1 2 2 2 3 0 0 1 1 1 1 2 2 2 3 0 0 1 1 2 2 3 data integration as point-to-point integrations but does so Medical Imaging

Screened Screen Failed Randomized withdrawn Completed Visits Expected: 2 Visits Outstanding: 256 in a more scalable and supportable manner. However, data OK Low integration does not need to be a synchronous exchange

Source: Perceptive Informatics. of data files, but some integrations have value when imple- mented in a synchronous manner using web services so Figure 1: The portal provides a single view of that one application performs a live call of another sys- high level study performance metrics with consoli- tem, inputting data, executing commands, and returning dated data from multiple clinical trial technologies. a response directly. This is one of the routes to product convergence and a way for the increased benefit of sim- must be capable of efficiently managing the complexity of plifying the workflow for the end user can be realized. To interactions and data between systems within a defined achieve convergence, however, may require adjustment to suite of technologies, but must also be capable of interacting individual products to ensure the function can be delivered with the potentially more complex combination of solutions effectively and appropriately. Let’s consider two examples operated by other parties within the clinical trial network. of product convergence: Enabling site users to utilize EDC to perform ran- Clinical technology integration platform domization and dispensing activities. Rather than create Until recently, most integration efforts in the clinical trials a monolithic application supporting full EDC and RTSM environment involved point-to-point solutions that require functionality, it is possible to use synchronous integration the creation of customized links between each application. between EDC and RTSM to achieve seamless workflow. The These point-to-point connections between trial technologies user requirement is to action randomization, dispensing, and provide significant benefits in removal of duplication of ac- pack replacement events from within the subject records held tivities and data, and eliminate the need to reconcile common by EDC, without having to exit the EDC application or log data between systems. However, there are inefficiencies and into another application. To achieve this, the CTIP must man- limitations inherent in this approach. Typically, point-to-point age web service interactions between the EDC and RTSM integration requires custom links to be built between each applications to ensure that when a randomization event is set of applications, and these usually require rebuilding for actioned, for example, the appropriate subject data from EDC each study. In addition, because of the number of connections is transmitted to RTSM and the randomization number and often in play, it is complex to support and maintain full visibil- medication pack numbers allocated are returned and pre- ity of all the moving parts in a single study—not to mention sented through the EDC interface. To operate seamlessly, a multiple studies. The number of point-to-point connections number of modifications to the EDC application are required. often required also means more complex testing and valida- First, during the EDC study design phase, the designer tion activities are required and potentially repeated should requires the capability to define visits that map to certain one solution be modified or upgraded mid-study. RTSM events and identify specific data points within specific The objective of the clinical technology integration plat- eCRFs. These need to be provided to identify the subject form (CTIP) is to provide the same data integration bene- and operate the randomization. Second, the EDC interface fits in a more robust, repeatable, and supportable way. The needs modifications to enable RTSM actions to be accessed CTIP is a software platform or hub that sits in the “middle” simply, and the capability to report web-service status, dis- of other applications—serving as a central platform that play returned information appropriately, and alert the user to facilitates and manages all interactions between multiple error details if a subject event cannot be performed for some technology systems. Each application is connected via a reason—for example, the subject is not eligible. Behind the single connection to the CTIP only, providing scalibility scenes, the application needs to be enabled for web-service and increased supportability—these connections can be operations. The end result, a converged product combining made in such a way as they do not require re-building for EDC and RTSM functionality, provides a single application each study, but simply configuration. The CTIP controls for the end user to perform their workflow efficiently.

February 2011 appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS SUPPLEMENT 13 eClinical TRIALS

Enabling sponsor users to action user accounts for As we consider how multiple applications can be pre- clinical trial applications directly from their CTMS sented effectively together through a common framework application. CTMS applications contain the names, ad- it is helpful to look at the example of the Apple iPhone. dresses, and contact details of many of those involved in The utility and popularity of the iPhone are a result of operating a clinical trial—in particular, study site person- three things: value—the convenience and usability that nel. These provide the vital user details required when is achieved by the presentation of multiple applications creating and managing user accounts for the required trial through a single unit; design—great look and feel, intuitive technology applications such as EDC and RTSM. Enabling navigation and (some would say) coolness; and quality— CTMS to write these details into these applications and function underpinned by robust and reliable performance. action automatic creation and distribution of user accounts Examining these in the context of portal and identity man- would assist sponsor workflow and ensure that all applica- agement software helps to focus on some key principles that tions contain the most up-to-date information when user should be aimed to achieve in bringing together data, infor- mation, and applications through a portal framework. Value. We’ve stopped expecting to carry multiple de- vices to perform the things we like to do—phone, music Portal software provides a framework player, camera, GPS—yet we have this precise expectation for web-based access to a broad range of our study sites and study teams whom we require to uti- lize more and more independent technology applications to of data and applications. perform their clinical trial activities. Portal software pro- vides an opportunity to develop a framework within which details change. Again, implementing this concept requires all trial applications and data can be accessed with the ap- changes to the individual applications. For example, CTMS propriate rights and security. The portal, however, is only may not contain all the user types and details required of value if it does not add to the burden of specific users but by the receiving applications, and changes to the user ac- helps them to work efficiently. Site-sponsor collaboration count creation and management processes may need to be portals, for example, can only be effective if they help sites implemented in the receiving application. This is just one to complete their work and activities and don’t simply cre- example of convergence that could utilize CTMS to trigger ate additional tasks to perform for the benefit of the spon- actions in other systems. sor or CRO. Bringing applications together within a single This approach to simplifying workflow through appropri- framework provides value greater than the sum individual ate product convergence can be brought further forward components when: through the effective use of portal and identity manage- • Users have a single point of authentication providing ment applications. access to all their applications without multiple log-ons, achieved through effective use of identity management Portal and identity management applications applications. In its broadest definition, the Oxford English Dictionary • Data and metrics are consolidated from multiple defines a portal to be “a doorway, gate, or other entrance...” databases such as CTMS, EDC, ePRO, and RTSM, That in mind, portal software is an essential component of and displayed in a user-role-specific manner that helps the eClinical-enabling platform as it can provide a framework the specific user type understand their progress and through which to provide web-based access to a broad range manage their work, achieved through data integration of data and applications, consolidated through a single entry and effective information architecture to enable data to point. For example, entering the portal could give a user ac- be consolidated and reported effectively (Figure 1). cess to information (study protocols and documents, study • Functions that live in specific applications can be news and announcements), data (study metrics and data exposed in a way that guides the workflow of the reports consolidated from multiple applications, for example user. For example, the portal might bring together all CTMS, EDC, RTSM, and others), and study applications they queries from EDC, ePRO, imaging and safety systems have rights to access, such as EDC. This is a critical com- and present them together as outstanding tasks to the ponent of further product convergence in providing a single site user. framework from which all applications and activities can be • Additional application portlets can be included that accessed via a single log-on. Achieving this also requires an broaden the activities and information users can access, identity management application to ensure that users can such as collaboration, news, and discussion areas. be granted access to multiple applications via a single user • The framework permits access to multiple studies, ID, and ultimately that active sessions can be recognized be- programs, and portfolios through a single entry point tween applications so that additional sign-on is not required. dependent upon the access rights of the user.

14 APPLIED CLINICAL TRIALS SUPPLEMENT appliedclinicaltrialsonline.com February 2011 Clinical Program Strategy Data Collection Services Approval Services/Market Access Concept evaluation DiaryPRO®: Patient eDiaries PRO dossier development and management Instrument evaluation, selection SitePRO®: Site-based assessments Regulatory meeting and inspection support and modifi cation EPX™: Web-based ePRO management system Scientifi c communication services Migration of instrument to electronic format

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In creating iPhone, Apple has also created a framework ing technology and applying consistent reporting stan- standard enabling others to design and publish “apps.” dards facilitates this. This is a value add for iPhone and the same holds true for a Devising an architecture that enables data from across portal—additional value comes from a standard framework multiple applications to be consolidated in a warehouse or that makes it easy to construct new compatible portlets that mart means that all essential data from multiple technolo- can be applied in combination with others to comprise a gies can be accessed and reported alongside each other specific portal application. through a single interface. More importantly, pulling to- Design. Usability is a key requirement for any trial gether data from disparate applications can provide more technology. Intuitive to use, simple navigation should en- valuable metrics and insights. An example is measurement able the user to rapidly access the data, information, or of the data visibility gap. An RTSM system contains real- function they require to perform their activities. Combined time data on patient visits, as randomization and dispens- with an understanding of user-specific workflow, portal ing actions within RTSM are performed while the patient applications can present activities and data in a way that is is in clinic. This data provides insight into the progress of able to guide the user to their most critical tasks and help other activities—for example, how long does it take the site them complete their work efficiently. The applications and to begin the data entry activities on the EDC application, or data presented with most prominence may change depend- to ship a medical image to the core laboratory. Consolidat- ing on the stage of the study, making it easy for users to ing the data from these applications in near real time facili- get to where they need to rapidly. Application of design tates such measurements. In turn, a CTIP technology read- principles and user interface standards will ensure that ily enables consolidation, ensuring that the data warehouse users do not have steep learning curves when utilizing new or mart is fed with up-to-date data from each solution. functions exposed through the portal. When providing or An important consideration around implementation is exposing access to other applications through the portal, data security. In the individual technology solutions, ac- common interface and navigation rules and standards cess rights within the application controls access to data make the use of a product suite more effective. Microsoft (or subsets of the data). For example, within RTSM certain achieved this in the creation of their Office suite where users such as those managing clinical supplies may require diverse products can be used with a familiar and common access to unblinded data to monitor the usage of medica- navigation and interface. tion units within each treatment group. Access to this data Quality. All the above are great conceptually, but with- is controlled through the rights management of the RTSM out a powerful enabling platform and well considered ar- application. When you remove the data from the RTSM ap- chitecture and infrastructure it is unlikely to be successful. plication, you need to apply the same security rules to en- Users seek reliable and robust solutions that improve and sure users are only exposed to data their role type allows. aid the completion of their required activities. This is one of the methodologies that can be applied by an As an industry we may have some way to go to deliver identity management solution. the vision described above, but knowing the vision enables us to determine the steps toward achieving that end game. Conclusion Achieving this vision for the future requires a powerful Enterprise reporting application enabling platform composed of the right building blocks Each technology used in clinical trials contains data to enable the delivery of fully integrated and interoperable from which valuable reports can be delivered. One prob- systems to support comprehensive data access, streamlined lem is that a user, such as a trial director, may have to workflow, and overall greater efficiency improvements in visit the reports contained in multiple applications to clinical development. This vision is focused not simply on obtain the information they need. These reports display providing advanced and tighter integration between a de- the data in different styles and formats—meaning that fined suite of products, but also on providing a framework if you were to compile these into a summary report the to enable effective interaction with a complex collection of result would be a mismatch of styles and formats. This applications hosted remotely by other organizations. Only makes it difficult for the reviewer to easily interpret the then will there be effective information flow across various contents due to having to reorientate when viewing data functions and organizations involved in executing clinical presented using a variety of approaches. For example, studies. A key goal is to enable greater visibility into trials bar charts created by two applications may present coun- and improve data access for faster, better decision making. try totals using an alternate color key and differing axis scales. Studies have shown that the use of color can be Bill Byrom, PhD, is Senior Director of Product Strategy, used to make quick association; conversely, inconsistent Perceptive Informatics, Nottingham, UK, e-mail: Bill. color schemes can confuse. Utilizing a common report- [email protected].

16 APPLIED CLINICAL TRIALS SUPPLEMENT appliedclinicaltrialsonline.com February 2011

eClinical TRIALS

Vito Anthony Losito and Rodd Schlerf Manage Trial Master Files via Investigative Portals Automated eTMF solutions reduce costs, improve productivity, and enhance data management.

s pharmaceutical companies face field-based personnel—is located in a centralized intense pressures from looming patent place, making it readily available for viewing and expirations, weak drug pipelines, tracking by trial personnel from any geographic Aand heightened competition, they are location. eTMF solutions also allow assembly of implementing new technologies to the TMF to occur gradually during the course of improve operational efficiencies in clinical trials the study. As such, eTMFs accelerate the produc- and speed drugs to market. Document workflows tion, review, approval, and submission stages in in a clinical trial environment require coordination addition to eliminating time-consuming and costly of tasks and people from multiple organizations processes that diminish clinical trial efficiency. including the study sponsors, CROs, investigator EntraLogix, a site management organization sites, academic institutions, and research ethics that developed an investigator portal solution for its boards. During study start-up and throughout the own needs, which is now commercialized, reports course of a trial, a number of essential regulatory cutting study site initiation time from an average documents have to be processed in a short period of 102 days to an average of 49 days through the of time. Most recently, CTMS and investigator use of its investigator portal system. By automating portals have automated trial master files (TMF) the clinical development process and cutting down and regulatory workflows and played a central role the days to site initiation, CROs and sponsors in enabling companies to expedite study start-up can potentially gain valuable time to market their while significantly reducing costs, improving approved compounds under patent protection. collaboration and data management, and speeding site/study initiation. Evolution of the investigator portal A TMF consists of thousands of pages, and Second generation investigator portals are includes everything from regulatory documents, web-based collaboration platforms designed to correspondence, and data to documentation that aid in TMF management. The TMF consists supports compliance with local regulations. With of regulatory documents as well as artifacts paper-based TMF systems, managing documenta- related to the clinical trial that permit the tion is a time-consuming and cumbersome task evaluation of the trial conduct and quality of the that often involves eliminating duplicates (gener- data produced. The latest portal technologies ated in multi-center clinical trial environments leverage enterprise-level collaboration, where documents reside in various organizations document management, electronic forms, and and/or across geographical regions), replacing digital signature technology to integrate the lost documents, scanning, indexing, and filing. En- TMF with investigator site files (ISF), data, and suring that all required documents are included in metadata. These new clinical trial applications the final TMF, with required approvals, and man- handle documents electronically throughout the aging metadata also become arduous tasks when entire document lifecycle, and cover all steps using a paper-based system. With an eTMF solu- from site selection to study close out. Third tion, however, all documentation—including docu- generation investigator portals are designed and ments from sponsors, subsidiaries, CROs, and developed specifically for TMF requirements.

18 APPLIED CLINICAL TRIALS SUPPLEMENT appliedclinicaltrialsonline.com February 2011 eClinical TRIALS

Investigator Portal Workflow Study start-up time In the past 12 months, EntraLogix has been using an eTMF

Start system built on enterprise level portal web application PDF FDF PDF FDF technology, electronic forms, and digital signatures. The company started eight new clinical trials and reduced PDF FDF its average study start-up from 102 days to 49 days from initial site contact to site initiation. EntraLogix’s regulatory Sponsor alerted via Sponsor approves email to QC form form online documents remain in electronic format from conception online as per SOP to archiving. Digital signatures are a key part of the Sponsor uploads PDF smart Form End solution because investigators sign documents from their

PDF FDF computers, regardless of their geographic location. Equally important, digital signatures allow maintenance of an eTMF without the need to digitize documents. Figure 1 uses a financial disclosure form to demonstrate how Investigator alerted by email with link to access form online Investigator fills and documents are processed electronically. signs electronically Evaluating automated eTMF solutions Source: Entralogix and ARX. Investigator portals have evolved from information Figure 1. Investigator portal process broken down gateways to web-based automated eTMF applications that into five steps. allow online collaboration, centralization of documents, and control over the regulatory process. These systems are built on business process automation, and the integration Using enterprise level portal/application technology such of disparate applications, workflows, and data. as Websphere or Weblogic, the clinical trial web applications Portal technology. Possibly the most important factor offer a full set of features for online collaboration, regulatory to consider when evaluating an eTMF solution is the document processing, and data integration. Through portal’s adherence to standards. An eTMF solution must document workflow and task management capabilities be able to easily integrate with disparate applications. combined with electronic forms and digital signatures, To be able to integrate, the portal technology used organizations are using these investigator portals needs to comply with Java Portlet Specification (JSR) to streamline operations while significantly shortening 168. This enables interoperability among portlets and timelines, reducing costs, and speeding development. portals by defining a set of APIs for portlets and addresses With investigator portals, life science companies are standardization for preferences, user information, portlet also meeting the desire of regulatory authorities to have requests, responses, deployment packaging, and security. clinical documents submitted electronically. One of the key Examples of compliant portal technologies are: BEA initiatives of investigator portals is referred to by the FDA Weblogic, IBM Websphere Portal, and Oracle Portal. as “Leaving the Paper-Based World Behind—Creating an Electronic forms. Instrumental to business process All-Electronic Environment for Managing Data on FDA- automation is the electronic form. Aside from eliminating the Regulated Products.”1 The Agency has been developing hassle and cost associated with printing, distributing, and standards and systems that will enable the electronic archiving paper forms, electronic forms can be completed receipt, management, and storage of FDA-regulated product more quickly because they can automatically format, calculate, information. The FDA will use the Janus data warehouse to look up, and validate information for the user. Further, with store and manage study data about the products it regulates, digital authorization and routing via secure web server, review as well as clinical study information. Further, data exchange and approval cycle times can be significantly reduced. standards are being developed to provide a consistent way Electronic forms initially emerged as a means to for information across organizations to be handled and to replicate a paper document on a computer screen. Today, ensure that sending and receiving systems both understand electronic forms provide a richer, interactive environment what information is being exchanged. This is a significant for end users. For instance, an investigator attempting to leap forward as it demonstrates direct exchange of data from complete a financial disclosure form can be guided through the systems of life science companies to the FDA’s system. the process of completing the form. After investigators Whereas transmission of scanned PDF documents provides have completed the electronic form they simply submit it information that is static, difficult to query, and non-relational, online. The next person in the business process, such as electronic forms allow end users to enter, retrieve, and display the sponsor’s document reviewer, is then automatically data, while digital signatures are used to authorize it. notified to review and approve the form online.

February 2011 appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS SUPPLEMENT 19 eClinical TRIALS

Digital signatures that the signature solution is intuitive for site personnel. A Digital signatures allow source documents to be signed digital signature solution that requires extensive training and maintained electronically without ever introducing will not be adopted as easily or quickly as one that is intuitive paper into the process. They eliminate the cumbersome and simple for end users to adopt. This carries the risk of processes of printing, routing, scanning, and archiving reintroduction of paper into the regulatory workflow for paper documents solely for the purpose of obtaining signature authorization purposes, which would consequently signature authorizations. Further, digitally-signed delay site initiation and other processes in addition to electronic records are compliant with worldwide regulations incurring added costs. It is also important for the digital including the FDA 21 CFR, Part 11. As a result, they provide signature system to allow for easy system administration legally enforceable electronic records that are recognized including the ability to quickly add signing permissions to by sponsor organizations and regulatory authorities. remote personnel, and also remove signing capabilities once Organizations that implement automated eTMF solutions the signing requirements and/or study are completed. with digital signatures benefit from expedited business processes and significant cost reduction, while maintaining Practical considerations legal and regulatory compliance. The use of eTMF is well underway, and certainly beyond It is essential to understand the difference between the early adoption stage. Well-designed eTMF solutions “digital signatures” and “electronic signatures.” Digital that make it easier for organizations to manage the signatures are a sub-category of electronic signatures that investigator site file and related documents have been well- provide heightened levels of integrity and non-repudiation. received and easily implemented across hundreds of sites. Whereas proprietary (closed-system) electronic signatures The bigger challenge to adoption of eTMF solutions are can only be trusted and verified within a specific the life science companies. With workflows and processes application, standard digital signatures allow any party that span many disparate systems, hundreds to thousands of to verify the signature for signer identity and intent, users, various departments, different geographic locations, and content integrity, regardless of the system(s) they and well-established standard operating procedures, are using. In eTMF solutions, digital signatures have implementing an eTMF solution naturally seems daunting. various advantages, including: open system trust, where Thankfully, experience with eTMF solutions has shown that signed electronic records are portable, sustainable, and there is a golden path for successful implementation within completely self-contained; security, where non-repudiation life sciences organizations. is ensured and indication of tampering is always provided; The first step is to develop a vision for your organization. and compliance with the strictest industry regulations. Implementing a good eTMF solution is a gated process that Investigator portals with integrated digital signature takes between two to five years. The eTMF solution should capabilities enable the various participants in a clinical be a transactional system that includes electronic forms trial, including sponsors, CROs, investigators, and IRBs, and digital signatures, and captures data in a relational to sign the documents that constitute TMFs. These database system. The system should be a robust, external- documents include NDAs, financial disclosures, 1572s, facing portal web application with functions for all clinical CVs, protocols, IRB approvals, informed consents, trial service providers including investigators, site personnel, agreements, contracts, certifications, safety letters, drug IRBs, auditors, and third-party vendors. Further, it shipment and handling forms, delegation of duties forms, should include integration with existing internal-facing and others. Digital signatures are also being used to document management systems and data exchange with authorize project plans, internal audit reports, archiving organizations such as the FDA. forms and expense reports, as well as in other clinical With a vision in place, it is possible to start developing activities such as site monitoring reporting and site close the requirements that your organization needs to achieve out reports. By enabling the participants in a clinical the end goal. List, in no specific order, all the functions trial to digitally sign off on these electronic documents, your eTMF solution must be able to do. In addition to a delays, costs and low-level security associated with paper- functional requirements list, you also need to consider the based documentation are eliminated. In addition, since technical requirements. There are a number of important the documents are being created, signed, and distributed technical items to consider when looking at purchasing electronically using standard digital signatures, any party or developing an eTMF solution that are consistent with with access to the documents can verify the signer’s the industry’s migration to paperless clinical trials. identity and document content integrity—inside or outside First, the future of clinical trials will depend heavily on of the investigator portal. data interchange; as such, your eTMF solution must be When evaluating the digital signature solution in use designed and built for data interchange. The solution must with an automated eTMF system, it’s important to ensure have electronic forms that produce pure XML. Also, the

20 APPLIED CLINICAL TRIALS SUPPLEMENT appliedclinicaltrialsonline.com February 2011 eClinical TRIALS

electronic forms must be able to capture data in a relational service providers to track and manage their documents database. The electronic forms must be compliant with electronically. The second stage of implementation should ODM and HL7 standards. Lastly, the electronic forms must include the implementation of electronic forms and digital be integrated with a compliant digital signature solution. signatures. This will significantly reduce the need to digitize, Second, your solution should be J2EE compliant as there index and file documents. Document, workflow, and task are a number of important advantages to this architecture. management is now completely electronic and spans the With J2EE servlets and portlets, the solution can use entire spectrum of clinical service providers regardless server-side to process all requests such that the client only of organization or time zone. This is when significant needs a web browser. Also, J2EE is a services oriented gains are made in productivity and study start-up times architecture with compliance with a number of important are significantly shortened. The final stage of eTMF standards, making integration with back-end document implementation is integration with existing internal management systems and data interchange much simpler. document management systems and data exchange. With functional and technical requirements in place, it is now time to investigate the eTMF solutions available on the References market. If you can find a commercial eTMF solution that 1. Food and Drug Administration, Innovation/Stagnation: Chal- meets the top 80 percent of your requirements out of the box, lenge and Opportunity on the Critical Path to New Medical Prod- the chances of successfully implementing the system are ucts (FDA, Rockville, MD 2004). very high. With your solution selected, it is time to plan the implementation gates for key functions. When it comes time Vito Anthony Losito* is Director, Clinical Trial Systems at to start implementing your eTMF solution, start with the EntraLogix Systems Inc., 38 Prospect Street, Newmarket, ON, most fundamental piece: a portal for all the TMF documents. L3Y 3S9, e-mail: [email protected]. Rodd Schlerf, is Documents that must be printed for signatures are digitized FDA and USDA Markets Manager at ARX. during the study and placed in the eTMF. The first stage of implementation should include functions for all the clinical *To whom all correspondence should be addressed.

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February 2011 appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS SUPPLEMENT 21 eClinical TRIALS

Website: www.criteriuminc.com Business: 919-673-4001 Contact: Ronny Schnel Fax: 206-338-3663 DATATRAK INTL INC E-mail: [email protected] eCLINICAL TRIALS Website: www.eolusinc.com 6150 Parkland Blvd Ste 100 Contact: Phyllis Weldon Mayfi eld Heights, OH 44124 Toll free: 888-677-3282 FIRECREST CLINICAL Business: 440-443-0082 One Mary Rosse Centre, Holland Rd Fax: 440-442-3482 National Technology Park DIRECTORY E-mail: [email protected] Limerick, Ireland Website: www.datatrak.net Business: 353-6-134-5222 Contact: Lisa Pahl E-mail: info@fi recrestclinical.com DECISIONVIEW INC Website: www.fi recrestclinical.com Contact: Alan Horgan CTMS Toll free: 877-654-0033 330 Townsend St #234 Business: 650-292-5300 San Francisco, CA 94107 FORTRESS MEDICAL ACORN CRO Fax: 650-292-5301 Business: 415-538-1800 SYSTEMS LLC 1770 Kirby Pkwy Ste 400 E-mail: [email protected] Fax: 415-538-1810 32 10th Ave S Ste 205 Memphis, TN 38138 Website: www.biopharm.com E-mail: [email protected] Hopkins, MN 55343 Toll free: 877-767-2267 Contact: Michelle Zubatch Website: www.decisionview.com Business: 952-238-9010 Business: 901-435-5570 Contact: Lucy Lopez E-mail: [email protected] Fax: 901-260-9280 CHILTERN DEDICATED PHASE 1 INC Website: www.fortressmedical.com E-mail: [email protected] 1241 Volunteer Pkwy Ste 950 734 W Highland Ave Contact: Patricia Feulner Website: www.acorncro.com Bristol, TN 37620 Phoenix, AZ 85013 GxPi LTD Contact: Kristie Lively Business: 423-968-9533 Business: 602-279-7300 Fax: 423-968-3567 Unit 13 Poplars Ct, Lenton Lane ACUMEN HEALTHCARE Fax: 602-279-7311 E-mail: [email protected] Nottingham, NG7 2PW SOLUTIONS LLC E-mail: santino.bonanza@ United Kingdom Website: www.chiltern.com dedicatedphase1.com 14252 23rd Ave N Contact: Stuart McGuire Business: 44-1159-248-475 Plymouth, MN 55447 Website: www.dedicatedphase1.com Fax: 44-1159-248-472 Business: 763-559-8232 CISYS LIFESCIENCES Contact: Santino Bonanza E-mail: [email protected] Fax: 763-559-2821 eClinical Research Technologies DR OESTREICH + PARTNER GMBH Website: www.gxpi.com E-mail: [email protected] 8386-103 Six Forks Rd Hansaring 102-104 Contact: Mark Stevens Website: www.acumenhealthcare.com Raleigh, NC 27615 Cologne, D-50670 Germany HEALTH DECISIONS Contact: William Kobi Business: 919-870-1436 Business: 49-2219-128-710 2510 Meridian Pkwy Fax: 919-870-8626 Fax: 49-2219-128-711 AKAZA RESEARCH Durham, NC 27713 E-mail: [email protected] E-mail: [email protected] Business: 919-967-1111 460 Totten Pond Rd Website: www.cisys.com Website: www.oandp-cro.com Fax: 919-967-1145 Waltham, MA 02451 Contact: Jim Kelley Contact: Wolfgang Oestreich Business: 617-621-8585 E-mail: [email protected] Fax: 617-621-0065 CLINICAL DATAFAX SYSTEMS INC DSG INC Website: www.healthdec.com E-mail: [email protected] 25 Main St W Ste 500 325 Technology Dr Contact: Katie Hendrick Website: www.openclinica.com Hamilton, ON L8P 1H1 Canada Malvern, PA 19355 ICSE EUROPE Contact: Stan Wysocki Business: 905-522-3282 Business: 484-913-0210 E-mail: [email protected] Expoconsult BV, Industrieweg 54 BEARDSWORTH—GLOBAL CRO Fax: 905-522-7284 Maarssen, 3606 The Netherlands E-mail: [email protected] Website: www.dsg-us.com SPECIALIST FOR COMPLEX Contact: David Grace Business: 31-03-465-59444 CLINICAL TRIALS Website: www.datafax.com Fax: 31-03-465-73811 Contact: Wayne Taylor DUKE CLINICAL RESEARCH E-mail: [email protected] 70 Church St INSTITUTE Flemington, NJ 08822 CLINOVO Website: www.icsexpo.com Business: 908-788-1729 1208 E Arques Ave Ste 114 2400 Pratt St, P.O. 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Box 3090 ECLINSO Wilmington, DE 19806 826 Newtown-Yardley Rd Iowa City, IA 52244-3090 160 Chubb Ave Ste 206 Business: 302-658-8444 Newtown, PA 18940 Business: 319-626-8888 Lyndhurst, NJ 08550 Fax: 302-658-7894 Toll free: 888-392-7456 Fax: 319-626-8750 Business: 201-372-1465 E-mail: [email protected] Business: 267-757-3000 E-mail: [email protected] Fax: 201-372-0406 Website: www.labware.com Fax: 267-757-3010 Website: www.compleware.com E-mail: [email protected] Contact: Steve Neri Contact: John Weiler, MD E-mail: [email protected] Website: www.eclinso.com LOGOS TECHNOLOGIES INC Website: www.bioclinica.com CRITERIUM INC Contact: Howard Goldberg Contact: Mark Endres 91 Peterborough Rd 358 Broadway Ste 201 EOLUS COMPLIANCE London, SW6 3BU United Kingdom BIOPHARM SYSTEMS Saratoga Springs, NY 12866 SOLUTIONS LLC Business: 44-8458-385-900 2000 Alameda de las Pulgas Ste 154 Business: 518-583-0095 9660 Falls of Neuse Rd Ste 138-154 Fax: 44-8707-478-600 San Mateo, CA 94403-1270 E-mail: [email protected] Raleigh, NC 27615 E-mail: [email protected]

22 APPLIED CLINICAL TRIALS SUPPLEMENT appliedclinicaltrialsonline.com February 2011 eClinical TRIALS

Website: www.logostechnologies.com Fax: 650-506-7200 Business: 33-5-5331-9716 Business: 781-449-7032 Contact: Giles Wilson E-mail: [email protected] Fax: 33-5-5331-6291 Fax: 781-444-1763 MAJARO INFOSYSTEMS INC Website: www.oracle.com/ E-mail: [email protected] E-mail: [email protected] healthsciences Website: www.sigmasoftintl.com Website: www.waife.com 2350 Mission College Blvd Ste 700 Contact: Dennis Constantinou Contact: Steve M. Colville Contact: Ronald Waife Santa Clara, CA 95054 Business: 408-330-9400 PAREXEL INTL SIMBEC RESEARCH LTD WINCHESTER BUSINESS E-mail: [email protected] 195 West St Merthyr Tydfi l Ind Park, Cardiff Rd SYSTEMS INC Website: www.majaro.com Waltham, MA 02451 Merthyr Tydfi l, South Wales CF48 4DR 237 Lexington St Ste 10 Contact: Katie Fortman Business: 781-487-9900 United Kingdom Woburn, MA 01891 Business: 44-1443-694-309 Toll free: 888-749-7150 MEDELIS INC Fax: 781-768-5512 E-mail: [email protected] Fax: 44-1443-692-499 Business: 781-503-0200 2200 21 Ave S Website: www.parexel.com E-mail: [email protected] Fax: 781-503-0207 Nashville, TN 37212 Contact: Sean McIntosh Website: www.simbec.co.uk E-mail: [email protected] Business: 615-297-6105 Contact: Alan Woodward Website: www.wbsnet.com PERCEPTIVE INFORMATICS Fax: 615-297-6539 SRA INTL Contact: Michael O. Regentz E-mail: [email protected] 195 West St 79 TW Alexander Blvd WORLDWIDE CLINICAL TRIALS Website: www.medelis.com Waltham, MA 02451 Research Triangle Park, NC 27709 Contact: David Browning Toll free: 866-289-4464 1000 Continental Dr Business: 919-607-3070 Business: 781-487-9900 King of Prussia, PA 19406 MEDIDATA SOLUTIONS E-mail: [email protected] Business: 610-964-2000 WORLDWIDE Fax: 781-768-5512 E-mail: [email protected] Contact: Dave Dworaczyk E-mail: [email protected] 79 Fifth Ave 8th Flr Website: www.perceptive.com STUDYMANAGER Website: www.wwctrials.com New York, NY 10003 Contact: Kathleen Pomykola Contact: Laura Fleming Toll free: 877-511-4200 520 Pike St Ste 2522 Seattle, WA 98101 Business: 212-918-1791 PERCIPENZ TECHNOLOGIES INC EDC (PDAs, eDiaries) Fax: 212-918-1818 Business: 206-728-0313 708 Heartland Trail Ste 1800 ACORN CRO E-mail: [email protected] E-mail: [email protected] Madison, WI 53717 Website: www.mdsol.com Website: www.studymanager.com 1770 Kirby Pkwy Ste 400 Business: 608-826-6000 Contact: Peter Fama Contact: Larissa Amoroso Memphis, TN 38138 Fax: 608-826-6005 SYREON CORP Toll free: 877-767-2267 MEDNET SOLUTIONS E-mail: [email protected] Business: 901-435-5570 601 Carlson Pkwy Ste 605 Website: www.percipenz.com 260 - 1401 W 8th Ave Fax: 901-260-9280 Minnetonka, MN 55305 Contact: Kerri Phillips Vancouver, BC V6H 1C9 Canada E-mail: [email protected] Business: 604-676-5900 Toll free: 866-258-2735 PHARM-OLAM INTL Website: www.acorncro.com Business: 763-258-2735 Fax: 604-676-5911 Contact: Kristie Lively 450 N Sam Houston Pkwy Fax: 763-258-2737 E-mail: [email protected] E Ste 250 ACUMEN HEALTHCARE E-mail: [email protected] Website: www.syreon.com Houston, TX 77060 SOLUTIONS LLC Website: www.mednetstudy.com Contact: Brendan Keown Business: 713-559-7900 14252 23rd Ave N Contact: Brian Sweeney TFS TRIAL FORM SUPPORT Fax: 713-559-7901 Plymouth, MN 55447 MEDPACE E-mail: [email protected] Ruben Rausings gata 11 B Business: 763-559-8232 4620 Wesley Ave Website: www.pharm-olam.com Lund, SE-223 55 Sweden Fax: 763-559-2821 Cincinnati, OH 45212 Contact: Eric Rupprath Business: 46-4-62-801-800 E-mail: [email protected] Business: 513-579-9911 PHARMANET Fax: 46-4-62-801-801 Website: www.acumenhealthcare.com E-mail: tfs.international@ Fax: 513-579-0444 504 Carnegie Center Contact: William Kobi trialformsupport.com E-mail: [email protected] Princeton, NJ 08540-6242 Website: www.trialformsupport.com ADVANCED CLINICAL Website: www.medpace.com Business: 609-951-6842 Contact: Catherine Soldano Contact: Daniel Spasic 1901 Butterfi eld Rd Ste 190 E-mail: [email protected] Downers Grove, IL 60515 MEDRIO Website: www.pharmanet.com TRANSPERFECT LIFE SCIENCES Business: 877-995-9222 1330 Broadway Ste 831 Contact: Anne-Marie Hess 3 Park Ave 39 Flr Fax: 312-506-8568 Oakland, CA 94612 PPD New York, NY 10016 E-mail: jheneghan@ Toll free: 877-763-3746 929 N Front St Business: 212-689-5555 advancedclinical.com Business: 415-963-3700 Wilmington, NC 28401-3331 E-mail: [email protected] Website: www.advancedclinical.com E-mail: [email protected] Toll free: 800-948-8002 Website: lifesciences.transperfect.com Contact: Julie Heneghan Contact: Ryan Simper Website: www.medrio.com Business: 910-251-0081 AKAZA RESEARCH Contact: Daniel Casentini Fax: 910-762-5820 TRIO CLINICAL RESEARCH 460 Totten Pond Rd E-mail: [email protected] OBIS INC 8045 Arco Corporate Dr Ste 200 Waltham, MA 02451 Website: www.ppdi.com 670 Bradway Raleigh, NC 27617 Business: 617-621-8585 Contact: Betty Vermillion New York, NY 10012 Toll free: 877-309-8746 Fax: 617-621-0065 Business: 212-254-2508 REALITY CORP INC Business: 919-401-1800 E-mail: [email protected] E-mail: [email protected] 240 N James St Ste 103 Fax: 919-403-7139 Website: www.openclinica.com Website: www.obis.com Newport, DE 19804 E-mail: [email protected] Contact: Stan Wysocki Website: www.trioclinicalresearch.com Contact: Rick Beasley Business: 302-995-2770 ALLPHASE CLINICAL Contact: Kurt Mussina OMNICOMM SYSTEMS INC Website: www.realitycorp.com RESEARCH INC Contact: Robert Pochadt 2101 W Commercial Blvd Ste 4000 VIRTIFY 33 Wood Ave Ste 675-B Flr 6 Ft Lauderdale, FL 33309 RHOMBUS CONSULTING INC 55 Cambridge Pkwy Ste 410 Iselin, NJ 08830 Business: 954-473-1254 1404 Granby Way Cambridge, MA 02142 Toll free: 877-223-1990 Fax: 954-473-1256 West Chester, PA 19380 Business: 617-252-0770 Business: 732-744-3435 E-mail: [email protected] Business: 610-209-2092 Fax: 617-812-0378 Fax: 732-744-3436 Website: www.omnicomm.com E-mail: [email protected] E-mail: [email protected] E-mail: [email protected] Contact: Steve Johnson Website: www.rhombusconsulting.com Website: www.virtify.com Website: www.allphaseclinical.com ORACLE HEALTH SCIENCES Contact: Brian Dakin Contact: Dwight Galler Contact: Angelo Panzica 500 Oracle Pkwy SIGMASOFT INTL WAIFE & ASSOCIATES INC ALMAC Redwood Shores, CA 94065 Mas de Cause 62 Warren St Clinical Technologies Toll free: 800-ORACLE1 Daglan, 24250 France Needham, MA 02492 1040 Stony Hill Rd Ste 200 February 2011 appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS SUPPLEMENT 23 eClinical TRIALS

Yardley, PA 19067 Business: 905-522-3282 Toll free: 888-677-3282 Website: www.eolusinc.com Business: 267-685-4284 Fax: 905-522-7284 Business: 440-443-0082 Contact: Phyllis Weldon E-mail: clinicaltechnologies@ E-mail: [email protected] Fax: 440-442-3482 almacgroup.com Website: www.datafax.com E-mail: [email protected] ERT Website: www.almacgroup.com Contact: Wayne Taylor Website: www.datatrak.net 1818 Market St Ste 1000 Contact: Meghan Adams Contact: Lisa Pahl Philadelphia, PA 19103-3638 CLINILABS INC Business: 215-972-0420 ASIAN CLINICAL TRIALS 423 W 55th St 4th Flr DECISIONVIEW INC Fax: 215-972-0414 Serene Chambers, Rd #5 Ave 7, New York, NY 10019 330 Townsend St #234 E-mail: [email protected] Banjara Hills Business: 646-215-6400 San Francisco, CA 94107 Website: www.ert.com Hyderabad, 500 034 India Fax: 646-215-6401 Business: 415-538-1800 Contact: Sheryl Walder Business: 91-40-2354-3314 E-mail: [email protected] Fax: 415-538-1810 Fax: 91-40-2355-0501 Website: www.clinilabs.com E-mail: [email protected] EXCO INTOUCH LTD E-mail: [email protected] Contact: Jeanine Estrada Website: www.decisionview.com Pishiobury House, Pishiobury Dr Website: www.act-india.com Sawbrideworth, Herts CM21 0AF CLINOVO Contact: Lucy Lopez Contact: Venkatraman Sunder United Kingdom 1208 E Arques Ave Ste 114 DEDICATED PHASE 1 INC Business: 44-1279-709-040 BEARDSWORTH—GLOBAL CRO Sunnyvale, CA 94085 734 W Highland Ave Fax: 44-1279-201-234 SPECIALIST FOR COMPLEX Toll free: 800-987-6007 Phoenix, AZ 85013 E-mail: [email protected] E-mail: [email protected] CLINICAL TRIALS Business: 602-279-7300 Website: www.excointouch.com Contact: Sophie McCallum 70 Church St Fax: 602-279-7311 Contact: Tim Davis Flemington, NJ 08822 CLINSYS CLINICAL RESEARCH E-mail: santino.bonanza@ Business: 908-788-1729 dedicatedphase1.com FORTRESS MEDICAL Bldg A 2nd Flr, One Crossroads Dr Fax: 908-788-5281 Website: www.dedicatedphase1.com SYSTEMS LLC Bedminster, NJ 07921 E-mail: [email protected] Business: 908-947-7777 Contact: Santino Bonanza 32 10th Ave S Ste 205 Website: www.beardsworth.com Fax: 908-947-7953 DR OESTREICH + Hopkins, MN 55343 Contact: Dan P. Diaz Business: 952-238-9010 E-mail: [email protected] PARTNER GMBH E-mail: [email protected] BIOCLINICA INC Website: www.clinsys.com Hansaring 102-104 Website: www.fortressmedical.com 826 Newtown-Yardley Rd Contact: Mitchell Winfree Cologne, D-50670 Germany Contact: Patricia Feulner Newtown, PA 18940 COLORADO ALLERGY & ASTHMA Business: 49-2219-128-710 Toll free: 888-392-7456 CENTERS Fax: 49-2219-128-711 GLOBAL IQ INC Business: 267-757-3000 Research E-mail: [email protected] 10230 Jasper Ave Ste 4-570 Fax: 267-757-3010 1667 Cole Blvd Bldg 19 #205 Website: www.oandp-cro.com Edmonton, AB T5J 4P6 Canada E-mail: [email protected] Lakewood, CO 80401 Contact: Wolfgang Oestreich Business: 780-420-0633 Website: www.bioclinica.com Business: 303-432-9707 DSG INC Fax: 780-420-0646 Contact: Mark Endres E-mail: [email protected] Fax: 303-420-5974 325 Technology Dr BIOPHARM SYSTEMS E-mail: [email protected] Malvern, PA 19355 Website: www.globaliq.com 2000 Alameda de las Pulgas Ste 154 Website: www.coloradoallergy.com Business: 484-913-0210 Contact: Paul Braconnier San Mateo, CA 94403-1270 Contact: Gail Facciolo E-mail: [email protected] GVK BIOSCIENCES Toll free: 877-654-0033 COMPLEWARE CORP Website: www.dsg-us.com Cinical Research Business: 650-292-5300 P.O. 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Box 138 Contact: Doug Moehring 601 Carlson Pkwy Ste 605 Website: www.outcome.com Miamiville, OH 45147 Minnetonka, MN 55305 Contact: Kristin Narolewski KFORCE CLINICAL RESEARCH INC Toll free: 800-785-2693 Toll free: 866-258-2735 PARAGON BIOMEDICAL Business: 513-831-3114 1001 E Palm Ave Business: 763-258-2735 Fax: 513-831-1217 Tampa, FL 33605 Fax: 763-258-2737 9685 Research Dr E-mail: [email protected] Toll free: 866-230-7992 E-mail: [email protected] Irvine, CA 92618 Website: www.hill-top.com E-mail: [email protected] Website: www.mednetstudy.com Toll free: 6 PARAGON Contact: John Lyssikatos Website: www.kforce.com/ Contact: Brian Sweeney Business: 949-224-2800 clinicalresearch E-mail: [email protected] ICON CLINICAL RESEARCH Contact: Eleanore Doyle MEDPACE Website: www.parabio.com 212 Church Rd 4620 Wesley Ave Contact: Jared Byer North Wales, PA 19454 KIKA CLINICAL SOLUTIONS Cincinnati, OH 45212 PAREXEL INTL Business: 215-616-3000 21 Milk St Business: 513-579-9911 Fax: 215-699-6288 Boston, MA 02109 Fax: 513-579-0444 195 West St E-mail: [email protected] Business: 617-422-0854 E-mail: [email protected] Waltham, MA 02451 Website: www.iconclinical.com E-mail: [email protected] Website: www.medpace.com Business: 781-487-9900 Website: www.kikaclinicalsolutions.com Fax: 781-768-5512 ICSE EUROPE Contact: Catherine Soldano Contact: Zaher El-Assi E-mail: [email protected] Expoconsult BV, Industrieweg 54 MEDRIO Website: www.parexel.com Maarssen, 3606 AS The Netherlands KRONOS COMMUNICATED 1330 Broadway Ste 831 Contact: Sean McIntosh Business: 31-03-465-59444 DATA INC Oakland, CA 94612 Fax: 31-03-465-73811 456 N Tamiami Trail Toll free: 877-763-3746 PERCEPTIVE INFORMATICS E-mail: [email protected] Osprey, FL 34229 Business: 415-963-3700 195 West St Website: www.icsexpo.com Toll free: 888-538-1690 E-mail: [email protected] Waltham, MA 02451 Contact: Ian O’Malley Business: 941-966-1400 Website: www.medrio.com Toll free: 866-289-4464 INFERMED Fax: 941-966-6191 Contact: Daniel Casentini Business: 781-487-9900 E-mail: [email protected] Fax: 781-768-5512 25 Bedford Sq Website: www.kronosdata.com NEXTRIALS INC E-mail: [email protected] London, WC1B 3HW United Kingdom Contact: Elida Ramberger 5000 Executive Pkwy Ste 540 Website: www.perceptive.com Business: 44-2072-917-410 San Ramon, CA 94583 Contact: Kathleen Pomykola Fax: 44-2072-917-489 LABWARE INC Business: 925-355-3000 E-mail: [email protected] 3 Mill Rd Ste 102 E-mail: [email protected] PERCIPENZ TECHNOLOGIES INC Website: www.infermed.com Wilmington, DE 19806 Website: www.nextrials.com 708 Heartland Trail Ste 1800 Contact: Duane Lawrence Business: 302-658-8444 Contact: Alan Arroyo Madison, WI 53717 INTEGRATED RESEARCH INC Fax: 302-658-7894 NOVELLA CLINICAL Business: 608-826-6000 E-mail: [email protected] 1351 Sunnybrooke Blvd Fax: 608-826-6005 Website: www.labware.com 4309 Emperor Blvd Ste 400 Dollard-des-Ormeaux, QC H9B 3K9 E-mail: [email protected] Contact: Steve Neri Durham, NC 27703 Canada Website: www.percipenz.com Business: 919-484-1921 Contact: Kerri Phillips Business: 514-683-1909 LOGOS TECHNOLOGIES INC E-mail: [email protected] Fax: 514-683-0121 91 Peterborough Rd Website: www.novellaclinical.com PFC PHARMA FOCUS LTD E-mail: [email protected] London, SW6 3BU United Kingdom Contact: Kristi Robison Chriesbaumstrasse 2 Website: www.iricanada.com Business: 44-8458-385-900 Volketswil, Zurich 8604 Switzerland Contact: Joanne E. Watson OCTAGON RESEARCH Fax: 44-8707-478-600 SOLUTIONS INC Business: 41-44-908-66-66 E-mail: [email protected] Fax: 41-44-908-66-77 INVENTIV CLINICAL SOLUTIONS 585 E Swedesford Rd Website: www.logostechnologies.com E-mail: birgit.hennecke-janzer@ 16225 Park Ten Place Ste 200 Wayne, PA 19087 Contact: Giles Wilson pfc-cro.com Houston, TX 77084 Business: 610-535-6500 Toll free: 877-559-6699 MAX NEEMAN INTL Fax: 610-535-6515 Website: www.pfc-cro.com Contact: Birgit Hennecke-Janzer Business: 281-829-1110 121 Edinburgh S Dr Ste 103 E-mail: [email protected] E-mail: [email protected] Cary, NC 27511 Website: www.octagonresearch.com PHARM-OLAM INTL Website: www.inventivclinical.com Business: 919-424-3302 Contact: Kathleen Bouldin 450 N Sam Houston Pkwy E Ste 250 Contact: Chris Crucitti Fax: 919-852-5574 OMNICOMM SYSTEMS INC Houston, TX 77060 INVIVODATA INC E-mail: donald.swankie@ 2101 W Commercial Blvd Ste 4000 Business: 713-559-7900 2100 Wharton St Ste 505 neeman-medical.com Ft Lauderdale, FL 33309 Fax: 713-559-7901 Pittsburgh, PA 15203 Website: www.neeman-medical.com Business: 954-473-1254 E-mail: [email protected] Business: 412-390-3000 Contact: Donald Swankie Fax: 954-473-1256 Website: www.pharm-olam.com E-mail: [email protected] MEDELIS INC E-mail: [email protected] Contact: Eric Rupprath Website: www.invivodata.com 2200 21 Ave S Website: www.omnicomm.com PHARMANET Contact: Jodi Andrews Nashville, TN 37212 Contact: Steve Johnson 504 Carnegie Center KAI RESEARCH INC Business: 615-297-6105 ORACLE HEALTH SCIENCES Princeton, NJ 08540-6242 11300 Rockville Pike Ste 500 Fax: 615-297-6539 500 Oracle Pkwy Business: 609-951-6842 Rockville, MD 20852-43008 E-mail: [email protected] Redwood Shores, CA 94065 E-mail: [email protected] Business: 301-770-2730 Website: www.medelis.com Toll free: 800-ORACLE1 Website: www.pharmanet.com Fax: 301-770-4183 Contact: David Browning Fax: 650-506-7200 Contact: Anne-Marie Hess E-mail: [email protected] MEDIDATA SOLUTIONS E-mail: [email protected] PPD Website: www.kai-research.com Website: www.oracle.com/ WORLDWIDE 929 N Front St Contact: Selma C. Kunitz healthsciences 79 Fifth Ave 8th Flr Wilmington, NC 28401-3331 Contact: Dennis Constantinou KENDLE New York, NY 10003 Toll free: 800-948-8002 441 Vine St Ste 500 Toll free: 877-511-4200 OUTCOME Business: 910-251-0081 Cincinnati, OH 45202 Business: 212-918-1791 201 Broadway 5th Flr Fax: 910-762-5820 Toll free: 800-733-1572 Fax: 212-918-1818 Cambridge, MA 02139 E-mail: account.development@ Business: 513-381-5550 E-mail: [email protected] Toll free: 888-526-6700 rtp.ppdi.com Fax: 513-381-5870 Website: www.mdsol.com Business: 617-621-1600 Website: www.ppdi.com E-mail: [email protected] Contact: Peter Fama Fax: 617-621-1620 Contact: Betty Vermillion

26 APPLIED CLINICAL TRIALS SUPPLEMENT appliedclinicaltrialsonline.com February 2011 eClinical TRIALS

PREMIER RESEARCH GROUP LTD Website: www.rhombusconsulting.com Business: 919-401-1800 Business: 816-767-3900 Centre Square West, 1500 Market St Contact: Brian Dakin Fax: 919-403-7139 E-mail: [email protected] Ste 3500 E-mail: [email protected] Website: www.aptuit.com S-CLINICA Philadelphia, PA 19102 Website: www.trioclinicalresearch.com Contact: Rebecca Jackson Business: 215-282-5500 33 Wood Ave S Contact: Kurt Mussina E-mail: [email protected] Iselin, NJ 08830 ASIAN CLINICAL TRIALS UNITED BIOSOURCE CORP Website: www.premier-research.com Business: 732-767-5319 Serene Chambers, Rd #5 Ave 7, Contact: Jessica Barag Fax: 484-461-7591 7501 Wisconsin Ave Ste 705 Banjara Hills E-mail: temitope.koledoye@ Bethesda, MD 20814 Hyderabad, 500 034 India PRIMORUS CLINICAL TRIALS LTD s-clinica.com Business: 240-644-0420 Business: 91-40-2354-3314 Clinical Operations Website: www.s-clinica.com Fax: 240-644-0421 Fax: 91-40-2355-0501 40 Stewart St, P.O. Box 25081 (8013) Contact: Temitope Koledoye E-mail: [email protected] E-mail: [email protected] Website: www.unitedbiosource.com Christchurch, Canterbury 8011 SIGMASOFT INTL Website: www.act-india.com New Zealand Contact: Teresa Pokladowski Mas de Cause Contact: Venkatraman Sunder Business: 64-3-978-1278 Daglan, 24250 France VERISTAT Fax: 64-3-961-1579 AVERION INTERNATIONAL CORP Business: 33-5-5331-9716 1750 Washington St E-mail: [email protected] 225 Turnpike Rd Fax: 33-5-5331-6291 Holliston, MA 01746 Website: www.primorus.com E-mail: [email protected] Business: 508-429-7340 Southborough, MA 01772 Contact: Joanne Kepple Website: www.sigmasoftintl.com Fax: 508-429-5741 Business: 508-597-6000 PROMEDICA INTL Contact: Steve M. Colville E-mail: [email protected] Fax: 508-597-5789 Website: www.veristat.com E-mail: [email protected] 3100 Bristol St Ste 250 SIMBEC RESEARCH LTD Contact: Nicole Powell Website: www.averionintl.com Costa Mesa, CA 92626 Merthyr Tydfi l Ind Park, Cardiff Rd Business: 714-460-7363 Merthyr Tydfi l, South Wales CF48 4DR WAIFE & ASSOCIATES INC AXIOM ACCELERATED CLINICAL Fax: 714-460-7364 United Kingdom 62 Warren St PATIENT RECRUITMENT E-mail: [email protected] Business: 44-1443-694-309 Needham, MA 02492 624 E Park Ave, P.O. Box 7122 Website: www.promedica-intl.com Fax: 44-1443-692-499 Business: 781-449-7032 Libertyville, IL 60048 Contact: Ginger Clasby E-mail: [email protected] Fax: 781-444-1763 Toll free: 888-859-4656 QUADRATEK DATA Website: www.simbec.co.uk E-mail: [email protected] Fax: 847-362-7788 SOLUTIONS LTD Contact: Alan Woodward Website: www.waife.com E-mail: [email protected] Website: www.recruitpatients.com Old Potbridge Rd STUDYMANAGER Contact: Ronald Waife Contact: Jeffrey Clausing Winchfi eld, Hampshire RG27 8BT 520 Pike St Ste 2522 WATERS CORP United Kingdom Seattle, WA 98101 34 Maple St BILCARE GCS Business: 44-870-428-9039 Business: 206-728-0313 Milford, MA 01748 1-3 Waller House, Evicta Business Park E-mail: [email protected] E-mail: [email protected] Contact: Gregory Murphy Website: www.clincase.com Crickhowell, Powys NP8 1DF Website: www.studymanager.com United Kingdom Contact: Martin Krainz Contact: Larissa Amoroso WESTAT 1650 Research Blvd Business: 44-1873-812-182 QUALITYMETRIC INC SYMFO Rockville, MD 20850 Fax: 44-1873-810-836 24 Albion Rd Bldg 400 11 Beacon St Ste 1230 Business: 301-251-1500 E-mail: [email protected] Lincoln, RI 02865 Boston, MA 02108 E-mail: [email protected] Website: www.bilcaregcs.com Toll free: 800-572-9394 Toll free: 866-88-SYMFO Website: www.westat.com/ BIOCLINICA INC Business: 401-334-8800 Business: 617-577-9484 clinical_trials 826 Newtown-Yardley Rd Fax: 401-334-8801 E-mail: [email protected] Contact: Paul Milne E-mail: [email protected] Website: www.symfo.com Newtown, PA 18940 Website: www.qualitymetric.com Contact: Serge Bodart WORLDWIDE CLINICAL TRIALS Toll free: 888-392-7456 Contact: Sheila Hetu 1000 Continental Dr Business: 267-757-3000 SYREON CORP King of Prussia, PA 19406 Fax: 267-757-3010 QUINTILES 260 - 1401 W 8th Ave Business: 610-964-2000 E-mail: [email protected] 4820 Emperor Blvd Vancouver, BC V6H 1C9 Canada E-mail: [email protected] Website: www.bioclinica.com Durham, NC 27703 Business: 604-676-5900 Website: www.wwctrials.com Contact: Mark Endres Business: 919-998-2000 Fax: 604-676-5911 Contact: Laura Fleming Fax: 919-998-9113 E-mail: [email protected] CENDUIT LLC E-mail: [email protected] Website: www.syreon.com IVRS 1007 Slater Rd Ste 301 Website: www.quintiles.com Durham, NC 27703 Contact: Brendan Keown ALMAC REALITY CORP INC Business: 919-998-3891 TFS TRIAL FORM SUPPORT Clinical Technologies Fax: 919-998-3895 240 N James St Ste 103 Ruben Rausings gata 11 B 1040 Stony Hill Rd Ste 200 E-mail: [email protected] Newport, DE 19804 Lund, SE-223 55 Sweden Yardley, PA 19067 Website: www.cenduit.com Business: 302-995-2770 Business: 267-685-4284 Business: 46-4-62-801-800 Contact: Robert MacDougall Website: www.realitycorp.com Fax: 46-4-62-801-801 E-mail: clinicaltechnologies@ Contact: Robert Pochadt E-mail: tfs.international@trialformsup- almacgroup.com CISYS LIFESCIENCES Website: www.almacgroup.com REGISTRAT-MAPI port.com eClinical Research Technologies Website: www.trialformsupport.com Contact: Meghan Adams 2343 Alexandria Dr Ste 400 8386-103 Six Forks Rd Contact: Daniel Spasic Lexington, KY 40504 ANDERSON BRELON Raleigh, NC 27615 Toll free: 800-381-7878 TRANSPERFECT LIFE SCIENCES CLINICAL SERVICES Business: 919-870-1436 Business: 859-223-4334 3 Park Ave 39 Flr 4545 Assembly Dr Fax: 919-870-8626 Fax: 859-514-4350 New York, NY 10016 Rockford, IL 61109 E-mail: [email protected] E-mail: [email protected] Business: 212-689-5555 Business: 815-484-8900 Website: www.cisys.com Website: www.registratmapi.com E-mail: [email protected] Fax: 815-484-8904 Contact: Jim Kelley Contact: Amy Wynn Website: lifesciences.transperfect.com E-mail: [email protected] CLINOVO Contact: Ryan Simper Website: www.andersonpackaging.com RHOMBUS CONSULTING INC 1208 E Arques Ave Ste 114 Contact: Justin Schroeder 1404 Granby Way TRIO CLINICAL RESEARCH Sunnyvale, CA 94085 West Chester, PA 19380 8045 Arco Corporate Dr Ste 200 APTUIT INC Toll free: 800-987-6007 Business: 610-209-2092 Raleigh, NC 27617 Two Greenwich Offi ce Park E-mail: [email protected] E-mail: [email protected] Toll free: 877-309-8746 Greenwich, CT 06831 Contact: Sophie McCallum February 2011 appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS SUPPLEMENT 27 eClinical TRIALS

COLORADO ALLERGY & Business: 919-673-4001 MEDELIS INC Fax: 713-559-7901 ASTHMA CENTERS Fax: 206-338-3663 2200 21 Ave S E-mail: [email protected] Research E-mail: [email protected] Nashville, TN 37212 Website: www.pharm-olam.com 1667 Cole Blvd Bldg 19 #205 Website: www.eolusinc.com Business: 615-297-6105 Contact: Eric Rupprath Lakewood, CO 80401 Contact: Phyllis Weldon Fax: 615-297-6539 PHARMANET Business: 303-432-9707 E-mail: [email protected] ERT Fax: 303-420-5974 Website: www.medelis.com 504 Carnegie Center E-mail: [email protected] 1818 Market St Ste 1000 Contact: David Browning Princeton, NJ 08540-6242 Website: www.coloradoallergy.com Philadelphia, PA 19103-3638 Business: 609-951-6842 Contact: Gail Facciolo Business: 215-972-0420 MEDNET SOLUTIONS E-mail: [email protected] Fax: 215-972-0414 601 Carlson Pkwy Ste 605 Website: www.pharmanet.com COMPLEWARE CORP E-mail: [email protected] Minnetonka, MN 55305 Contact: Anne-Marie Hess P.O. Box 3090 Website: www.ert.com Toll free: 866-258-2735 PHASE FORWARD Iowa City, IA 52244-3090 Contact: Sheryl Walder Business: 763-258-2735 Business: 319-626-8888 Fax: 763-258-2737 77 Fourth Ave GxPi LTD Fax: 319-626-8750 E-mail: [email protected] Waltham, MA 02451 E-mail: [email protected] Unit 13 Poplars Ct, Lenton Lane Website: www.mednetstudy.com Toll free: 888-703-1122 Website: www.compleware.com Nottingham, NG7 2PW United Kingdom Contact: Brian Sweeney Business: 781-890-7878 Contact: John Weiler, MD Business: 44-1159-248-475 Fax: 781-890-4848 Fax: 44-1159-248-472 MEDPACE E-mail: elaine.maynard@ CRITERIUM INC E-mail: [email protected] 4620 Wesley Ave phaseforward.com 358 Broadway Ste 201 Website: www.gxpi.com Cincinnati, OH 45212 Website: www.phaseforward.com Saratoga Springs, NY 12866 Contact: Mark Stevens Business: 513-579-9911 Contact: Elaine Maynard Business: 518-583-0095 Fax: 513-579-0444 ICON CLINICAL RESEARCH PPD E-mail: [email protected] E-mail: [email protected] Website: www.criteriuminc.com 212 Church Rd Website: www.medpace.com 929 N Front St Contact: Ronny Schnel North Wales, PA 19454 Contact: Catherine Soldano Wilmington, NC 28401-3331 DATATRAK INTL INC Business: 215-616-3000 Toll free: 800-948-8002 Fax: 215-699-6288 OMNICOMM SYSTEMS INC 6150 Parkland Blvd Ste 100 Business: 910-251-0081 E-mail: [email protected] Mayfi eld Heights, OH 44124 2101 W Commercial Blvd Ste 4000 Fax: 910-762-5820 Website: www.iconclinical.com Toll free: 888-677-3282 Ft Lauderdale, FL 33309 E-mail: account.development@ rtp.ppdi.com Business: 440-443-0082 ICSE EUROPE Business: 954-473-1254 Fax: 954-473-1256 Website: www.ppdi.com Fax: 440-442-3482 Expoconsult BV, Industrieweg 54 E-mail: [email protected] Contact: Betty Vermillion E-mail: [email protected] Maarssen, 3606 The Netherlands Website: www.omnicomm.com Website: www.datatrak.net Business: 31-03-465-59444 PREMIER RESEARCH GROUP LTD Contact: Steve Johnson Contact: Lisa Pahl Fax: 31-03-465-73811 Centre Square West, 1500 Market St DECISIONVIEW INC E-mail: [email protected] OUTCOME Ste 3500 330 Townsend St #234 Website: www.icsexpo.com 201 Broadway 5th Flr Philadelphia, PA 19102 San Francisco, CA 94107 Contact: Ian O’Malley Cambridge, MA 02139 Business: 215-282-5500 E-mail: [email protected] Business: 415-538-1800 INVENTIV CLINICAL SOLUTIONS Toll free: 888-526-6700 Business: 617-621-1600 Website: www.premier-research.com Fax: 415-538-1810 16225 Park Ten Place Ste 200 Fax: 617-621-1620 Contact: Jessica Barag E-mail: [email protected] Houston, TX 77084 E-mail: [email protected] Website: www.decisionview.com Toll free: 877-559-6699 PROMEDICA INTL Website: www.outcome.com Contact: Lucy Lopez Business: 281-829-1110 Contact: Kristin Narolewski 3100 Bristol St Ste 250 DEDICATED PHASE 1 INC E-mail: [email protected] Costa Mesa, CA 92626 734 W Highland Ave Website: www.inventivclinical.com PAREXEL INTL Business: 714-460-7363 Phoenix, AZ 85013 Contact: Chris Crucitti 195 West St Fax: 714-460-7364 Business: 602-279-7300 KAI RESEARCH INC Waltham, MA 02451 E-mail: [email protected] Business: 781-487-9900 Website: www.promedica-intl.com Fax: 602-279-7311 11300 Rockville Pike Ste 500 E-mail: santino.bonanza@ Fax: 781-768-5512 Contact: Ginger Clasby Rockville, MD 20852-43008 dedicatedphase1.com E-mail: [email protected] Business: 301-770-2730 QUALITYMETRIC INC Website: www.dedicatedphase1.com Website: www.parexel.com Fax: 301-770-4183 Contact: Santino Bonanza Contact: Sean McIntosh 24 Albion Rd Bldg 400 E-mail: [email protected] Lincoln, RI 02865 DR OESTREICH + Website: www.kai-research.com PERCEPTIVE INFORMATICS Toll free: 800-572-9394 PARTNER GMBH Contact: Selma C. Kunitz 195 West St Business: 401-334-8800 Hansaring 102-104 KENDLE Waltham, MA 02451 Fax: 401-334-8801 Cologne, D-50670 Germany Toll free: 866-289-4464 E-mail: [email protected] 441 Vine St Ste 500 Business: 49-2219-128-710 Business: 781-487-9900 Website: www.qualitymetric.com Cincinnati, OH 45202 Fax: 49-2219-128-711 Fax: 781-768-5512 Contact: Sheila Hetu Toll free: 800-733-1572 E-mail: [email protected] E-mail: [email protected] Business: 513-381-5550 QUEENSLAND CLINICAL TRIALS Website: www.oandp-cro.com Website: www.perceptive.com Fax: 513-381-5870 Contact: Wolfgang Oestreich Contact: Kathleen Pomykola NETWORK INC (QCTN) E-mail: [email protected] Level 3 88 Jephson St ECLINSO Website: www.kendle.com PFC PHARMA FOCUS LTD Toowong, Queensland 4066 Australia 160 Chubb Ave Ste 206 Contact: Doug Moehring Chriesbaumstrasse 2 Business: 61-7-3331-3955 Lyndhurst, NJ 08550 Volketswil, Zurich 8604 Switzerland Fax: 61-7-3870-9101 Business: 201-372-1465 KRONOS COMMUNICATED Business: 41-44-908-66-66 E-mail: [email protected] Fax: 201-372-0406 DATA INC Fax: 41-44-908-66-77 Website: www.qctn.com.au E-mail: [email protected] 456 N Tamiami Trail E-mail: [email protected] Contact: Mario Pennisi Website: www.eclinso.com Osprey, FL 34229 Website: www.pfc-cro.com Contact: Howard Goldberg Toll free: 888-538-1690 Contact: Birgit Hennecke-Janzer REALITY CORP INC Business: 941-966-1400 240 N James St Ste 103 EOLUS COMPLIANCE Fax: 941-966-6191 PHARM-OLAM INTL Newport, DE 19804 SOLUTIONS LLC E-mail: [email protected] 450 N Sam Houston Pkwy E Ste 250 Business: 302-995-2770 9660 Falls of Neuse Rd Ste 138-154 Website: www.kronosdata.com Houston, TX 77060 Website: www.realitycorp.com Raleigh, NC 27615 Contact: Elida Ramberger Business: 713-559-7900 Contact: Robert Pochadt

28 APPLIED CLINICAL TRIALS SUPPLEMENT appliedclinicaltrialsonline.com February 2011 eClinical TRIALS

REGISTRAT-MAPI E-mail: [email protected] BIOPHARM SYSTEMS DSG INC 2343 Alexandria Dr Ste 400 Website: www.veracitylogic.com 2000 Alameda de las Pulgas Ste 154 325 Technology Dr Lexington, KY 40504 Contact: David Goldston San Mateo, CA 94403-1270 Malvern, PA 19355 Toll free: 800-381-7878 VERISTAT Toll free: 877-654-0033 Business: 484-913-0210 Business: 859-223-4334 Business: 650-292-5300 E-mail: [email protected] 1750 Washington St Fax: 859-514-4350 Fax: 650-292-5301 Website: www.dsg-us.com Holliston, MA 01746 E-mail: [email protected] E-mail: [email protected] Contact: David Grace Business: 508-429-7340 Website: www.registratmapi.com Website: www.biopharm.com Fax: 508-429-5741 DZS SOFTWARE SOLUTIONS INC Contact: Amy Wynn Contact: Michelle Zubatch E-mail: [email protected] 1661 Rte 22 W RHOMBUS CONSULTING INC Website: www.veristat.com CISYS LIFESCIENCES Bound Brook, NJ 08805 1404 Granby Way Contact: Nicole Powell eClinical Research Technologies Business: 732-764-6969 West Chester, PA 19380 WESTAT 8386-103 Six Forks Rd Fax: 732-764-6755 Business: 610-209-2092 Raleigh, NC 27615 E-mail: [email protected] 1650 Research Blvd E-mail: [email protected] Business: 919-870-1436 Website: www.clinplus.com Rockville, MD 20850 Website: www.rhombusconsulting.com Fax: 919-870-8626 Contact: Kim Vadney Business: 301-251-1500 Contact: Brian Dakin E-mail: [email protected] E-mail: [email protected] ECLINSO S-CLINICA Website: www.westat.com/clinical_trials Website: www.cisys.com Contact: Jim Kelley 160 Chubb Ave Ste 206 33 Wood Ave S Contact: Paul Milne Lyndhurst, NJ 08550 Iselin, NJ 08830 WORLDWIDE CLINICAL TRIALS CLEARTRIAL Business: 201-372-1465 Business: 732-767-5319 1000 Continental Dr 900 Oakmont Lane, 301 Fax: 201-372-0406 Fax: 484-461-7591 King of Prussia, PA 19406 Westmont, IL 60559 E-mail: [email protected] E-mail: [email protected] Business: 610-964-2000 Business: 630-986-9800 Website: www.eclinso.com Website: www.s-clinica.com E-mail: [email protected] Fax: 630-986-9801 Contact: Howard Goldberg Contact: Temitope Koledoye Website: www.wwctrials.com E-mail: [email protected] ENTIMO AG SIMBEC RESEARCH LTD Contact: Laura Fleming Website: www.cleartrial.com Contact: Mike Lange Stralauer Platz 33-34 Merthyr Tydfi l Ind Park, Cardiff Rd Berlin, 10243 Germany SOFTWARE PROGRAM CLINOVO Merthyr Tydfi l, South Wales CF48 4DR DEVELOPMENT Business: 49-3052-0024100 United Kingdom 1208 E Arques Ave Ste 114 Fax: 49-3052-0024101 Business: 44-1443-694-309 ACUMEN HEALTHCARE Sunnyvale, CA 94085 E-mail: [email protected] Fax: 44-1443-692-499 SOLUTIONS LLC Toll free: 800-987-6007 Website: www.entimo.com E-mail: [email protected] 14252 23rd Ave N E-mail: [email protected] Contact: Dimitri Kutsenko Website: www.simbec.co.uk Plymouth, MN 55447 Contact: Sophie McCallum EOLUS COMPLIANCE Contact: Alan Woodward Business: 763-559-8232 COGSTATE SOLUTIONS LLC TFS TRIAL FORM SUPPORT Fax: 763-559-2821 P.O. Box 302 9660 Falls of Neuse Rd Ste 138-154 Ruben Rausings gata 11 B E-mail: [email protected] Carlton South, Victoria 3053 Australia Raleigh, NC 27615 Lund, SE-223 55 Sweden Website: www.acumenhealthcare.com Business: 61-3-9664-1300 Business: 919-673-4001 Business: 46-4-62-801-800 Contact: William Kobi Fax: 61-3-9664-1301 Fax: 206-338-3663 Fax: 46-4-62-801-801 APPOINTMENT SEARCH E-mail: [email protected] E-mail: [email protected] E-mail: tfs.international@ 7830 Camino Real K 405 Contact: Sam Yeo Website: www.eolusinc.com trialformsupport.com Miami, FL 33143 COMPLEWARE CORP Contact: Phyllis Weldon Website: www.trialformsupport.com E-mail: [email protected] ERT Contact: Daniel Spasic P.O. Box 3090 Website: www.appointmentsearch.com Iowa City, IA 52244-3090 1818 Market St Ste 1000 TRANSPERFECT LIFE SCIENCES Contact: Manny Ormaza Business: 319-626-8888 Philadelphia, PA 19103-3638 3 Park Ave 39 Flr APTUIT INC Fax: 319-626-8750 Business: 215-972-0420 New York, NY 10016 Two Greenwich Offi ce Park E-mail: [email protected] Fax: 215-972-0414 Business: 212-689-5555 Greenwich, CT 06831 Website: www.compleware.com E-mail: [email protected] E-mail: [email protected] Business: 816-767-3900 Contact: John Weiler, MD Website: www.ert.com Website: lifesciences.transperfect.com E-mail: [email protected] CRITERIUM INC Contact: Sheryl Walder Contact: Ryan Simper Website: www.aptuit.com 358 Broadway Ste 201 FIRECREST CLINICAL Contact: Rebecca Jackson TRIO CLINICAL RESEARCH Saratoga Springs, NY 12866 One Mary Rosse Centre, Holland Rd 8045 Arco Corporate Dr Ste 200 ARX Business: 518-583-0095 National Technology Park Raleigh, NC 27617 855 Folsom Street, Suite 939 E-mail: [email protected] Limerick, Ireland Toll free: 877-309-8746 San Francisco, CA 94107 Website: www.criteriuminc.com Business: 353-6-134-5222 Business: 919-401-1800 E-mail: [email protected] Contact: Ronny Schnel E-mail: info@fi recrestclinical.com Fax: 919-403-7139 Contact: Rodd Schlerf DATATRAK INTL INC Website: www.fi recrestclinical.com E-mail: [email protected] Contact: Alan Horgan BIO/DATA CORP 6150 Parkland Blvd Ste 100 Website: www.trioclinicalresearch.com FORMEDIX Contact: Kurt Mussina 155 Gibraltar Rd, P.O. Box 347 Mayfi eld Heights, OH 44124 Horsham, PA 19044-0347 Toll free: 888-677-3282 15 New England Executive Park UNITED BIOSOURCE CORP Toll free: 800-257-3282 Business: 440-443-0082 Burlington, MA 01803 7501 Wisconsin Ave Ste 705 Business: 215-441-4000 Fax: 440-442-3482 Business: 781-685-4995 Bethesda, MD 20814 Fax: 215-443-8820 E-mail: [email protected] Fax: 781-685-4601 Business: 240-644-0420 E-mail: [email protected] Website: www.datatrak.net E-mail: [email protected] Fax: 240-644-0421 Website: www.biodatacorp.com Contact: Lisa Pahl Website: www.formedix.com E-mail: [email protected] Contact: William M. Trolio DR OESTREICH + PARTNER GMBH Contact: Sharon Forrester Website: www.unitedbiosource.com BIOCIS LTD THE BIOTECHNOL- FORTRESS MEDICAL SYSTEMS LLC Contact: Teresa Pokladowski Hansaring 102-104 OGY CENTER FOR INTL SERVICE Cologne, D-50670 Germany 32 10th Ave S Ste 205 VERACITY LOGIC LLC 245 First St 18th Flr Business: 49-2219-128-710 Hopkins, MN 55343 417 Colony Woods Dr, P.O. Box 2692 Cambridge, MA 02142 Fax: 49-2219-128-711 Business: 952-238-9010 Chapel Hill, NC 27515-2692 Business: 617-444-8727 E-mail: [email protected] E-mail: [email protected] Business: 919-338-8120 E-mail: [email protected] Website: www.oandp-cro.com Website: www.fortressmedical.com Fax: 919-869-2099 Contact: Philippa Wisseh Contact: Wolfgang Oestreich Contact: Patricia Feulner February 2011 appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS SUPPLEMENT 29 eClinical TRIALS

GVK BIOSCIENCES Website: www.kronosdata.com Fax: 303-666-4044 Business: 33-5-5331-9716 Cinical Research Contact: Elida Ramberger E-mail: [email protected] Fax: 33-5-5331-6291 Plot No 28A, IDA Nacharam LABWARE INC Website: www.nspirehealth.com E-mail: [email protected] Hyderabad, 500016 India Contact: Michael Brown Website: www.sigmasoftintl.com 3 Mill Rd Ste 102 Business: 91-12-4432-4000 Contact: Steve M. Colville Wilmington, DE 19806 OBIS INC Fax: 91-12-4432-4001 Business: 302-658-8444 670 Bradway SIMBEC RESEARCH LTD E-mail: [email protected] Fax: 302-658-7894 New York, NY 10012 Merthyr Tydfi l Ind Park, Cardiff Rd Website: www.gvkbio.com E-mail: [email protected] Business: 212-254-2508 Merthyr Tydfi l, South Wales CF48 4DR Contact: Vijay Rajan Vanchi Website: www.labware.com E-mail: [email protected] United Kingdom GxPi LTD Contact: Steve Neri Website: www.obis.com Business: 44-1443-694-309 Contact: Rick Beasley Unit 13 Poplars Ct, Lenton Lane LOGOS TECHNOLOGIES INC Fax: 44-1443-692-499 E-mail: [email protected] Nottingham, NG7 2PW 91 Peterborough Rd OCTAGON RESEARCH United Kingdom SOLUTIONS INC Website: www.simbec.co.uk London, SW6 3BU United Kingdom Contact: Alan Woodward Business: 44-1159-248-475 Business: 44-8458-385-900 585 E Swedesford Rd Fax: 44-1159-248-472 Fax: 44-8707-478-600 Wayne, PA 19087 TRIALYTICS E-mail: [email protected] E-mail: [email protected] Business: 610-535-6500 220 W Germantown Pike Website: www.gxpi.com Website: www.logostechnologies.com Fax: 610-535-6515 Plymouth Meeting, PA 19462 Contact: Mark Stevens Contact: Giles Wilson E-mail: [email protected] Business: 610-238-5289 HEALTH DECISIONS MASTERCONTROL INC Website: www.octagonresearch.com Fax: 610-834-8817 Contact: Kathleen Bouldin E-mail: [email protected] 2510 Meridian Pkwy 6322 S 3000 E Ste 110 PHARMANET Website: www.trialytics.com Durham, NC 27713 Salt Lake City, UT 84121 Contact: Malcolm Bohm Business: 919-967-1111 Toll free: 800-825-9117 v504 Carnegie Center Fax: 919-967-1145 Business: 801-942-4000 Princeton, NJ 08540-6242 VIRTU STAT LTD E-mail: [email protected] Fax: 801-942-7088 Business: 609-951-6842 1200 Turnbury Lane Website: www.healthdec.com E-mail: [email protected] E-mail: [email protected] North Wales, PA 19454-3656 Contact: Katie Hendrick Website: www.mastercontrol.com Website: www.pharmanet.com Business: 215-699-2424 Contact: Jason Clegg Fax: 215-699-3227 INFERMED Contact: Anne-Marie Hess MEDELIS INC PHARSIGHT—A CERTARA CO E-mail: [email protected] 25 Bedford Sq Website: www.virtustat.com 1699 S Hanley Rd London, WC1B 3HW United Kingdom 2200 21 Ave S Contact: Tad Archambault Business: 44-2072-917-410 Nashville, TN 37212 St Louis, MO 63144-2319 Fax: 44-2072-917-489 Business: 615-297-6105 Toll free: 800-323-2960 VITAL SYSTEMS INC E-mail: [email protected] Fax: 615-297-6539 Business: 919-859-6868 650 E Algonquin Rd Ste 205 Website: www.infermed.com E-mail: [email protected] E-mail: [email protected] Schaumburg, IL 60173-3846 Contact: Duane Lawrence Website: www.medelis.com Website: www.pharsight.com Business: 847-458-2900 Contact: David Browning Contact: Adam Rutkin Fax: 847-241-0116 INTELLITRIAL MEDPOINT COMM INC PPD E-mail: [email protected] 100 Portland Ave #250 929 N Front St Website: www.vtlsys.com Minneapolis, MN 55401 1603 Orrington Ave Ste 1900 Contact: George Stoms Evanston, IL 60201 Wilmington, NC 28401-3331 INTERLAB CENTRAL LAB Business: 847-869-4700 Toll free: 800-948-8002 WAIFE & ASSOCIATES INC SERVICES—WORLDWIDE E-mail: [email protected] Business: 910-251-0081 62 Warren St Fax: 910-762-5820 Bayerstr 53 Website: www.medpt.com Needham, MA 02492 E-mail: account.development@ Munich, D-80335 Germany Contact: Bill Cooney Business: 781-449-7032 rtp.ppdi.com Business: 49-8974-139-30 Fax: 781-444-1763 META SOLUTIONS INC Website: www.ppdi.com Fax: 49-8974-139-339 E-mail: [email protected] 63 Grove St Contact: Betty Vermillion E-mail: [email protected] Website: www.waife.com Somerville, NJ 08876 PROMEDICA INTL Contact: Ronald Waife Website: www.interlab.de Business: 908-393-9906 3100 Bristol St Ste 250 Contact: Hermann Schulz Fax: 908-791-9977 WATERS CORP Costa Mesa, CA 92626 E-mail: [email protected] 34 Maple St INVENTIV CLINICAL SOLUTIONS Business: 714-460-7363 Website: www.metasol.com Milford, MA 01748 16225 Park Ten Place Ste 200 Fax: 714-460-7364 Contact: Kim Nitahara Contact: Gregory Murphy Houston, TX 77084 E-mail: [email protected] Toll free: 877-559-6699 MISSION3 Website: www.promedica-intl.com WERUM SOFTWARE & Business: 281-829-1110 5060 N 40th St #209 Contact: Ginger Clasby SYSTEMS AG E-mail: [email protected] Phoenix, AZ 85018 RHOMBUS CONSULTING INC Wulf-Werum-Strasse 3 Website: www.inventivclinical.com Business: 602-957-2150 1404 Granby Way Lueneburg, 21337 Germany Contact: Chris Crucitti Fax: 602-957-2160 West Chester, PA 19380 Business: 49-4131-89-00-0 KAI RESEARCH INC E-mail: [email protected] Business: 610-209-2092 Fax: 49-4131-89-00-20 E-mail: [email protected] 11300 Rockville Pike Ste 500 Website: www.mission3.com E-mail: [email protected] Website: www.werum.com Rockville, MD 20852-43008 Contact: Chris Joslin Website: www.rhombusconsulting.com Contact: Lars Hornung Business: 301-770-2730 MMG Contact: Brian Dakin Fax: 301-770-4183 700 King Farm Blvd 5th Flr RUSH COMPUTER RENTAL WINCHESTER BUSINESS E-mail: [email protected] Rockville, MD 20850 901 Blairhill Rd Ste 300 SYSTEMS INC Website: www.kai-research.com Business: 301-984-7191 Charlotte, NC 28217 237 Lexington St Ste 10 Contact: Selma C. Kunitz Fax: 301-921-4405 Toll free: 800-786-5651 Woburn, MA 01891 KRONOS COMMUNICATED E-mail: [email protected] Business: 704-527-0191 Toll free: 888-749-7150 DATA INC Website: www.wegetpatients.com Fax: 704-527-0196 Business: 781-503-0200 Contact: Helen West E-mail: [email protected] Fax: 781-503-0207 456 N Tamiami Trail E-mail: [email protected] Osprey, FL 34229 nSPIRE HEALTH INC Website: www.rushcomputer.com Contact: Joe Korch Website: www.wbsnet.com Toll free: 888-538-1690 1830 Lefthand Circle Contact: Michael O. Regentz Business: 941-966-1400 Longmont, CO 80501 SIGMASOFT INTL Fax: 941-966-6191 Toll free: 800-574-7374 Mas de Cause INFORMATION CURRENT E-mail: [email protected] Business: 303-666-5555 Daglan, 24250 France AS OF AUGUST 2010

30 APPLIED CLINICAL TRIALS SUPPLEMENT appliedclinicaltrialsonline.com February 2011

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