Contract Research Organisation Medical and Pharmaceutical Projects Quality by design

For nearly 20 years CROMSOURCE has Whilst CROMSOURCE routinely works been trusted by the pharmaceutical, with many of the largest global life biotechnology, vaccine and medical science companies, the company remains device industries to deliver their a mid-sized organisation and offers an clinical trials and resolve their staffing adaptable structure to its customers, who requirements. Reputed for its customer quickly establish direct contacts with their focus, flexible approach and strong project team and senior management. This project management, CROMSOURCE approach is appreciated particularly by our receives an 80% level of repeat business. clients in the biotechnology and mid-sized pharmaceutical sectors. Established in 1994, CROMSOURCE began working not only in Western Europe, but The CROMSOURCE approach is ‘Quality also in the Central and Eastern European by Design’ – our focus on ensuring all regions, Russia and Ukraine. The depth aspects of operations are closely managed, of our experience (over 15 years) in including those of each single project, with these regions provides our clients with a view to proactively identify and prevent a key advantage when including these quality issues and operational threats important areas in their clinical development rather than relying solely on the ability to programmes. In this time CROMSOURCE react when they arise. Quality assurance is has worked across a broad range of guaranteed through the integrated, certified therapeutic areas and all phases of research. CROMSOURCE has notable experience in quality system ISO 9001 first achieved nearly medical device trials, having conducted a 10 years ago. You can be assured that large number of clinical investigations for a CROMSOURCE provides both high quality range of CAT II and CAT III devices. data and a high quality service. Expertise you can rely on

CROMSOURCE has successfully investigators in all regions. Perhaps the delivered hundreds of projects to greatest testament to the CROMSOURCE sponsors of every size in both the focus on quality and exceeding our biopharmaceutical and medical customers’ expectations is our steady device industries. growth and high levels of repeat business and our involvement in rescuing projects. CROMSOURCE has worked in many therapeutic areas and in all phases of clinical research. Operating across Western, Central and Eastern regions of Europe, Russia, Ukraine and the USA, we offer our customers access to rapidly enrolling, high quality research sites and to prestigious

“With the Feasibility Plus report delivered free and without obligation and the One Trial One Price guarantee it certainly makes sense to invite CROMSOURCE to provide a proposal...” Why choose CROMSOURCE?

CROMSOURCE is an ISO certified, full- value with the highly detailed feasibility service Contract Research Organization assessment delivered free and without providing clinical trial services and staffing obligation. solutions since 1994. Our team of over 400 Discover how our philosophy of “Quality by clinical research professionals deliver clinical Design” can contribute to your success! trials across Europe, Russia, Ukraine and the USA. CROMSOURCE provides a fixed price guarantee (One Trial One Price) and adds FEASIBILITY PLUSTM

CROMSOURCE is proud to present Feasibility Plus provides sponsors with Feasibility Plus: an extremely detailed a comprehensive report that details the feasibility analysis for your clinical suitability of the protocol design for trial conducted by our dedicated implementation by research sites as a TM FeasibilityONE team. Feasibility TRIAL Plus ONEwhole PRICE and in each individual country. involves direct contact with potential Of course, Feasibility Plus also provides investigators in all countries under accurate country and site selection data, consideration. insight into regulatory requirements, assessment of the impact of competitive trials and risk/mitigation strategy coupled with precise budget and timeline forecasts.TM Feasibility Plus is provided free TOTAL TRIAL VIEWand without obligation at the proposal stage. It is part of our commitment to provide accurate information and added value to our existing and potential clients.

QUALITY BY DESIGN TM

ADAPTIVE CLINICAL MANAGEMENT TM

EXPERT TRIAL RESCUETM FEASIBILITY PLUSTM

ONE TRIAL ONE PRICE TM

In our view sponsors should be able Put simply, One Trial One Price is our to rely on CRO cost proposals, and unique pledge that the price agreed should not be subject to numerous at contract signature is the only price change orders after contracts are that the Sponsor will pay. In this way, signed. As experts in the organisation, CROMSOURCETM provides our clients with a managementTOTAL and delivery TRIAL of clinical VIEWconcrete budget which contrasts markedly research, CROMSOURCE offers One with the change order culture prevalent in Trial One Price. today’s CRO industry. It is the embodiment of the CROMSOURCE commitment to deliver high quality data to our clients on time and on budget. QUALITY BY DESIGN TM

ADAPTIVE CLINICAL MANAGEMENT TM

EXPERT TRIAL RESCUETM FEASIBILITY PLUSTM

ONE TRIAL ONE PRICE TM

TOTAL TRIAL VIEW TM Make better decisions sooner

Typically, several separate electronic access real time information and implement databases are involved in a typical customisable reports across all the data. clinical research project (EDC, CTMS, IxRS, TM ePRO, DrugQUALITY Storage, Laboratory, BY Imaging DESIGN Through Total Trial View, CROMSOURCE etc) which makes a 360° vision of the implements Adaptive Clinical Management trial data difficult. The CROMSOURCE of each study. This approach increases solution is Total Trial View. efficiency by ensuring that each site receives the optimal level of resource and support. This highly efficient technology platform Additionally, because data is available in (ClinTrack®) is delivered from a secure central real time, study wide and local issues can hosting centre and integrates all databases be identified sooner, best practice is shared TM allowing the Sponsor and CROMSOURCE to and action plans can be implemented ADAPTIVE CLINICALmore quickly. MANAGEMENT

By supporting the efficient delivery of high quality data on time and on budget, Total Trial View is central to the CROMSOURCE philosophy of Quality by Design. Please contact us to find out more.

EXPERT TRIAL RESCUETM Flexible Staffing Solutions

CROMSOURCE continues to lead the We are equally comfortable acting in a way in providing flexible staffing functional service provider setting or in solutions. With nearly 20 years simply providing short and long term or experience of providing high quality permanent staff for your organisation. clinical research professionals, we CROMSOURCE is currently providing are able to add real value to your Staffing Solutions in over 20 countries important research programmes by with experts across all phases of research allowing you to efficiently adjust in virtually every therapy area for the size of your team to peaks pharmaceutical, vaccine, medical device in workload. and biotech companies. CROMSOURCE are equally proficient whether providing a single project manager or an international team of clinical research associates to work on either pharmaceutical or medical device projects.

Importantly, we provide one single point of contact within CROMSOURCE to each customer to address all their staffing needs, from new requirements to financial and operational management of all ongoing projects. CROMSOURCE also provides support for all contracted staff, including people management, training, coaching and appraisal meetings.

We look forward to discussing with you how CROMSOURCE Flexible Staffing Solutions can support your clinical research programmes.

CROMSOURCE Headquarters: Via Giorgio De Sandre, 3 37135 Verona - Italy

Phone +39 045 8222811 Fax +39 045 8222812 email [email protected]

www.cromsource.com Data Management & Biostatistics

Based on our experience from 200+ Once the design of your clinical trial paper and 50+ EDC (Electronic Data is defined, CROMSOURCE will ensure Capture) studies, the CROMSOURCE translation into the appropriate Clinical Data Management, protocol and data capture possibilities Biostatistics & Medical Writing teams with valuable input by the medical provide a wide range of services writing team. supporting your submissions and pre/ The same team contributes to the post product launch requirements. successful completion of your trial by authoring the clinical study report, abstracts, publications or presentations. CROMSOURCE data management We believe that statistical support is solutions continue to be refined and necessary at all stages of a clinical trial integrated with the latest proven (design, conduct, analysis, and reporting). technologies, including EDC and ePRO The use of up to date statistical methods to help maintain critical timelines and coupled with SAS technology can help ensure data quality and security. The in designing trials in the most efficient CROMSOURCE team has successfully way and in obtaining objective, reliable handled paper and EDC studies in all conclusions as early as it is possible. phases, in many therapeutics areas and within many technology platforms. Our in-house platform is Oracle Clinical with Oracle RDC. We are also experienced in using other EDC packages according to Sponsor preference.

CROMSOURCE Headquarters: Via Giorgio De Sandre, 3 37135 Verona - Italy

Phone +39 045 8222811 Fax +39 045 8222812 email [email protected]

www.cromsource.com CROMSOURCE Headquarters: Via Giorgio De Sandre, 3 37135 Verona - Italy

Phone: +39 045 8222811 Fax: +39 045 8222812 email: [email protected]

We have offices in:

Belgium Italy Poland Spain Ukraine Germany Netherlands Russia United Kingdom USA

www.cromsource.com