Clear Data. Clear Impact. 2018 Annual Report

Clear Data. Clear Impact.

2018 Annual Report Letter from the CEO What we do: How we do it: Why We Do It: Create Clarity. Individual Contributions. To Amplify Data’s Impact. Collective Power. In the ever-evolving clinical research landscape, CDISC provides critical clarity to amplify data’s impact. We achieve this through In the ever-evolving and complex clinical CDISC convenes a global community of research CDISC is driven by the belief that the true individual contributions from our tremendous volunteers, members, partner organizations, government regulators, and research landscape, CDISC provides critical experts representing a range of experiences and measure of data is the impact it has, but for staff, who come together across the globe to harness their collective power to drive more meaningful research. Among the clarity. We develop and advance data backgrounds. Each brings a vision, we bring the far too long, its full potential wasn’t being achievements in 2018, were the finalization of CDISC Library and the initial planning phase of an ambitious new project, CDISC standards of the highest quality to transform blueprint. They develop the data, we develop realized. So, we enable the accessibility, 360. CDISC is innovating clinical data standards to ensure they remain valuable and relevant into the future. incompatible formats, inconsistent the platform. They provide the insights, we interoperability, and reusability of data, CDISC grew in 2018 to more than 40 professional staff and nearly 100 contractors supporting a global community of more than methodologies, and diverse perspectives provide the focus. With everyone contributing helping the entire field of clinical research tap 2,300 volunteers. into a powerful framework for generating their unique strengths, we’re able to harness into—and amplify—its full value. From greater clinical research data that is as accessible as our collective power to drive more meaningful efficiency to unprecedented discoveries, we At CDISC, we believe that standards training for all should be considered an ongoing commitment in order to maximize program it is illuminating clinical research. make it possible to turn information into efficiencies and progress up your career ladder. To make this possible, in 2018 we invested in a year-long migration to a new invaluable impact for clinical research and online learning system. This easy-to-use system features interactive tools and augments the fine training already available via global health. CDISC Interchanges, public and private events, and webinars. As a fellow student of standards, I encourage you to check into our educational opportunities today.

In order to keep abreast of the changing needs of organizations, researchers, and regulators, the CDISC Board of Directors, under the leadership of Chair Stephen Pyke, an executive at long-time CDISC member company GSK, launched a Blue Ribbon Commission, co-chaired by HIMSS executive and CDISC Board member Joyce Sensmeier, RN, and Dr. Robert Califf, former Commissioner of US FDA. The Blue Ribbon Commissioners served as a strategic think tank for CDISC. The Blue Ribbon Commission was charged with preparing CDISC for the next phase of growth and development with work scheduled for completion in early 2019. This vision, in the form of written insights, will guide CDISC for the next decade.

CDISC continues a period of growth as more organizations are utilizing the CDISC standards and accruing the benefits of standardization of data. Medical and disease focused charitable groups are also taking notice and continue to provide the much needed funding it takes to continue in our efforts. Notably, The VIP Leona M. and Harry B. Helmsley Charitable Trust has awarded CDISC with a significant Innovation Grant, which will fund standards development for specific diseases as well as improvements that are aimed at speeding up the research process through technological advancements. Community Standards Education Events Membership It is a privilege to lead a small but mighty staff team that sits at the intersection of so much good work. It is clear that our community is in a period of significant change. Yet it is equally clear this community is confident in our commitment to quality data standards, effective implementation, and clear data. CDISC harnesses the vision For over 20 years, CDISC offers class- Attending an Inter- CDISC standards and Sincerely, and insights of each volun- we’ve taken a rigorous room and online train- change, meeting, or related innovations teer, member organization, approach to developing opportunities as volunteer event pro- would not be possible and partner to define a fo- ing and advancing data well as webinars cov- vides face-to face inter- without the dedicated cused approach for captur- standards. Pg. 6 ering a wide range of action with the CDISC volunteer efforts and ing and analyzing clinical re- topics and experience community. Pg. 12 financial assistance of David R. Bobbitt, MSc, MBA search data. Pg. 5 levels. Pg. 11 our member organiza- President and CEO tions. Pg. 16

2 Clear Data. Clear Impact. 3 Commitment Collective Power

Diverse Perspectives 2018 CDISC Board Members Convening a Community Collaboration and inclusivity have always been bedrocks of CDISC’s culture CDISC harnesses the vision and insights of each volunteer, member organization, and partner to define a focused approach for capturing and analyzing – and they remain central to our process today. It’s why we convene a global clinical research data. When the entire research community works together, we have the power to solve issues too complex for any one individual, team, or community of experts from across the research spectrum and facilitate the organization to address alone. development of standards that are open and available to all, enabling data sharing around the world. Thank you to every CDISC volunteer! Your contributions of talent, knowledge, and insight form the core of CDISC’s work and are critical to every success.

Our strength derives from the diverse perspectives of our community. Whether coming from a pharmaceutical organization, academic institution, regulatory agency, non-profit, or beyond, our contributors bring a range of experiences and backgrounds that drive more meaningful clinical research.

2018 Board of Directors

Stephen Pyke, Chair GSK Association of Clinical Research Douglas Peddicord, PhD, Chair-Elect Organizations (ACRO) C. David Hardison, PhD, Past-Chair Deloitte Thank You Chairman Pyke CDISC staff and volunteers enjoyed some A lively discussion during the German User CDISC Board Member Chris Decker gives an Volunteers from South Korea visit the Jonathan Chainey F. Hoffman-La Roche much deserved relaxation at the end of the Group Face-to-Face meeting. inspirational talk on innovation. CDISC office in Austin, Texas to discuss the 2018 Working Group Meeting. growing CDISC community in Korea. Charles Cooper, MD BD Diagnostics Chris Decker d-wise David Evans, MS Accenture Masanori Fukushima, MD, PhD Tri-Kobe Pam Howard ICON Margaret Keegan IQVIA Steve Rosenberg Oracle Information and Management Systems Joyce Sensmeier, MS, RN Society (HIMSS) Hirochimi Shirasawa, MD MSD Japan/Merck New York University Langone Medical Dave Scocca from CDISC Gold Member, Yoshiteru Chiba welcomes CDISC staff to CDISC SHARE Workshop J3C members and Japan Interchange John Speakman Center Rho, proudly encouraging attendees. the UMIN office at Tokyo University. sponsors shared the week’s events on social media. Névine Zariffa, M. Math AstraZeneca Incoming Chair Doug Peddicord and David R. Bobbitt thank amateur Jonathan Zung, PhD Covance beekeeper Steve Pyke with a personalized beehive box for his term as chair. 4 Clear Data. Clear Impact. 5 An Urgent Need: Quality Standards

CDISC Standards in the Clinical Research Process Therapeutic Area User Guides (TAUGs) Therapeutic Area (TA) Standards extend Clear data is essential to the success of research and the development of new treatments and therapies. CDISC Foundational Standards are Data Exchange Standards facilitate the sharing the Foundational Standards to represent data that pertains to specific disease areas. As of But far too often this data remains confined to one organization or one moment in time. When CDISC the basis of a complete suite of data of structured data across different information the end of 2018, CDISC had published over 32 TA standards. standards are applied, data is collected, organized, and analyzed in a clear and consistent manner so standards, enhancing the quality, systems. Data Exchange Standards are optimized that all researchers can leverage and share information from individuals and studies around the world. efficiency and cost effectiveness to represent CDISC content, and flexible enough Researchers spend a substantial amount of time deciphering, translating, and mapping unstandardized data. Implementing CDISC standards means that data can be structured For over 20 years, we’ve taken a rigorous approach to developing and advancing data standards for of clinical research processes from to be used by information systems that haven’t effectively and easily analyzed, leaving more time to focus on discoveries that will have clinical research and beyond. Each standard is informed and shaped by the expertise of those at beginning to end. implemented the Foundational Standards (e.g., the forefront of research today, making them not just of the highest quality, but also attuned to the invaluable impact on clinical research and global health. The following Therapeutic Area practicalities of their implementation. legacy data, academic studies). Standards were released in 2018: • Colorectal Cancer Protocol Representation Model (PRM) Standard for Exchange of Nonclinical Clinical Data Acquisition Standards CTR-XML lets technology vendors implement tools that support a provides a standard for planning and designing Data* (SEND) is an implementation of the Harmonization (CDASH) establishes a way • Huntington’s Disease “write once, use many times” solution based on a single XML file that a research protocol with focus on study design, SDTM standard to collect and present to collect data across studies so that formats • PTSD holds the information needed to generate submissions for multiple eligibility criteria, submittal requirements, and nonclinical data in a consistent format, and and structures provide clear traceability of clinical trials for clinical trial registry submissions primarily to the • Vaccines automating CRF creation and EHR configuration to support is one of the required standards for data submission to submission data into SDTM, delivering more transparency to World Health Organization (WHO),European Medicines Agency (EMA) research data sharing. the US FDA. regulators and others who conduct data review. EudraCT Registry and United States ClinicalTrials.gov. Dataset-XML supports exchanging tabular data in clinical research Clinical Research Process applications using ODM-based XML technologies, enabling the PRE-CLINICAL CLINICAL communication of study datasets for regulatory submissions. Therapeutic Area Standards ORGANIZE PLAN COLLECT ORGANIZE ANALYZE SUBMIT Define-XML* transmits metadata that describes any tabular dataset Published and In Development PUBLISH structure. When used with the CDISC content standards, it provides REPORT the metadata for human and animal model datasets using the SDTM and/or SEND standards and analysis datasets using ADaM. TYPE 1 HEART PTSD LAB provides a standard model for the acquisition and exchange of DIABETES FAILURE DATA EXCHANGE DATA EXCHANGE DATA EXCHANGE laboratory data, primarily between labs and sponsors or CROs. The ODM-XML ODM-XML Deﬁne - XML LAB standard was specifically designed for the interchange of lab data SDM-XML Dataset - XML acquired in clinical trials. PSORIASIS ODM-XML is a vendor-neutral, platform-independent format for SEND PRM CDASH SDTM ADaM exchanging and archiving clinical and translational research data, along with their associated metadata, administrative data, reference data, and audit information. ODM-XML facilitates the regulatory- Study Data Tabulation Model* (SDTM) Analysis Data Model* (ADaM) defines *Submission - The FDA (US) and PMDA CROHN’S compliant acquisition, archival and exchange of metadata and data. It DISEASE provides a standard for organizing and dataset and metadata standards that (Japan) require the use of SDTM, ADaM and has become the language of choice for representing case report form ACCUTE support efficient generation, replication, Define-XML for new drug applications. The KIDNEY formatting clinical study data to streamline content in many electronic data capture (EDC) tools. processes in collection, management, and review of clinical trial statistical FDA also requires the use of SEND. INJURY analysis and reporting. analyses, and traceability among analysis results, SDM-XML is an extension of ODM-XML and allows organizations to analysis data, and data represented in SDTM. provide rigorous, machine-readable, interchangeable descriptions of the designs of their clinical studies, including treatment plans, eligibility and times and events. SDM-XML defines three key sub- Controlled Terminology is the set of standard expressions (values) used with data items within CDISC-defined datasets. modules – Structure, Workflow, and Timing – permitting various levels of detail in any representation of a clinical study’s design. 6 Clear Data. Clear Impact. 7 Blue Ribbon Commission

Strategic Themes Context Grow Use Case Broad Theme #1: Better standards from inception Broad Theme #3: Focus and clarity In the spring of 2018, CDISC President and CEO David R. Bobbitt, with advice alignment and to better reflect the core biomedical concepts common to Commissioners acknowledged CDISC standards and consent of the CDISC Board of Directors under the leadership of Chair research protocols. As the use of real world data (RWD) in clinical research Refine the model CDISC is a small nonprofit organization with an are growing in use cases beyond the original use enormous mission. Commissioners agreed that Stephen Pyke, appointed a Blue Ribbon Commission to serve as a strategic grows, CDISC standardization remains necessary to maximize the value of Commissioners agreed unanimously that CDISC case of regulatory approvals. Commissioners CDISC must be focused and clear in articulating agreed that the most important use case for CDISC think tank for CDISC. The Blue Ribbon Commission was charged with real world evidence (RWE) in research datasets. CDISC must fundamentally should align all foundational standards around one core model so that CDISC becomes de facto one goals and strategies in order to be successful, to support above and ahead of all others in the preparing CDISC for the next decade of growth and change by considering change its historically hands-off approach to implementation. One key effort standard. Foundational standards (e.g., SDTM, especially to achieve success in influencing foreseeable future is standardization of academic what factors would most influence utilization of CDISC standards. to support implementation is to build a new content layer that standardizes ADaM, etc.) become views of data that can be the mightily powerful entities that CDISC must research, observational research, patient-reported Commissioners were selected to reflect the geographic reach of CDISC the transformation of data across the CDISC foundational standards. The accessed and assembled by users according regularly engage. outcomes, and real world evidence. CDISC standards will become de facto one standard, evolving to one well- to their requirements. This “refine the model” standards as well as to represent the industries and users of CDISC standards. Broad Theme #4: Build a strong standards Grow geographically Joyce Sensmeier, HIMSS executive and CDISC Board member, and Dr. Robert refined model on the back end where foundational standards, and therapeutic theme will help ensure the sustainability of CDISC The Commission recognizes that CDISC standards standards. CDISC must address the model as its ecosystem Califf, former Commissioner of the US FDA, co-chaired the Commission. area specific extensions, become views of data, while developing on the front are used globally and that mandates are useful end a more accessible profile so that non-experts can leverage the benefits highest priority. This is the overarching theme of While this theme was not identified in response to to support further adoption of the standards. Yet Over six months Commissioners met frequently, and these dedicated the Blue Ribbon Commission work. In many cases, any discrete question, Commissioners generally experts generated more than 200 pages of thoughts and discussion. Their of standardization. the Commission cautioned that CDISC standards Commissioners agreed to other priorities yet perceive CDISC standardization to be a critical should be chosen for quality more than merely recommendations, augmented by some staff comments, were incorporated CDISC must be prepared for future global growth by supporting a robust emphasized that refining the model must come resource, which like any resource must be deployed mandated. CDISC should be opportunistic into a high-level report. clinical data standards ecosystem. Central to this ecosystem is the CDISC first over other considerations. judiciously and sustained. Commissioners agreed whenever a regulatory agenda is interested in a Commissioners connected, as members of the CDISC community so often Library metadata repository. CDISC Library offers new ways to expose Improve implementation consistency that a strong standards ecosystem grows from closer relationship with CDISC. a healthy community of standards creators and do, over their shared passions which are bringing clarity to data, reducing and implement the CDISC standards as well as a new technology-based Commissioners agree that CDISC ought to build standards implementers. Each member of this Broad Theme #7: Explore new models for human suffering, curing diseases, supporting automation, enhancing platform from which to build and update CDISC standards. As part of this standards that are even more implementable robust ecosystem, CDISC as an organization should build on and extend from inception and that CDISC must support community has a critical role. CDISC is central to a membership and revenue while maintaining interoperability, and improving global health. healthy standards ecosystem. efforts beyond the sponsor-regulator focus to include the broader research implementers through training and education as current strengths well as through key partnerships. Summary of Insights landscape, with a renewed emphasis on support for academic researchers’ Broad Theme #5: Rely on key partnerships Commissioners generally perceived CDISC as doing effective utilization of the CDISC standards. a good job in building an effective membership The Commissioners believe that CDISC standards are, and will remain, Broad Theme #2: Optimize the volunteer labor CDISC is not an island. Everything CDISC does model and supporting the community through relevant for every aspect of the research enterprise; however, they also Above all, CDISC must remain a focused and productive global community, force affects others. Commissioners encouraged a well-staffed and well-managed organization. concluded CDISC must be prepared for significant changes as the research providing and demonstrating value for its members and stakeholders. This CDISC has been, and will remain, a volunteer-driven CDISC to be a good partner and to cultivate key Commissioners recognized that CDISC must partnerships. Commissioners noted certain world is undergoing substantial changes. New technologies combined with community is a welcoming place for volunteers where each member of the organization. Volunteering has changed over the reassess membership offerings from time to time community can bring their personal gifts and talents. This community builds first 20 years of CDISC’s existence and will likely partnerships, which are core to CDISC’s future to ensure relevance, and that CDISC in the course data from new sources will require CDISC to become nimbler and more vision. rapidly responsive to change. The core CDISC foundational standards model solid partnerships with other stakeholders and entities: there is much work continue to evolve; yet the core commitment of of good management ought to consider new volunteers pooling their expertise and knowledge and additional revenue streams. Commissioners must be fine-tuned both to support implementation through better internal to do, and more hands and minds to do this work will always be a gift. Broad Theme #6: Growth to fundamentally improve human health through provided a range of advice on these matters. well-crafted standards will remain unchanged in The Commission recommended growth from two the coming decade. perspectives: use cases and geographic. Special Thanks to Our Blue Ribbon Commissioners

8 Clear Data. Clear Impact. 9 CDISC Library Education

Greater Clarity Starts with CDISC Education New hires augmented the talent already working and learning health systems. The API facilitates in Data Science. CDISC volunteer and former SDS the implementation of CDISC standards to further New Learning Management System Classroom Training Webinars team leader Mike Hamidi joined CDISC as Head of automate clinical research processes. In 2018, CDISC continued to innovate in ways CDISC classroom training courses provide Our webinar series provides ongoing training Data Science. Long-time CDISC volunteer and well- we deliver educational opportunities completing expert-led training sessions for individuals and and discussion on hot topics in research. These known authorized instructor, Sally Cassells, joined CDISC Library is the successor to CDSIC SHARE, a year-long migration to a new online learning organizations of all experience levels and cover expert-led discussions can be attended at home LIBRARY as Senior Director, Data Exchange Standards. an early innovation in the community. In listening to the feedback from CDISC’s community and management system (LMS). This LMS features material from standards specified in the FDA’s or in the office, and past offerings are available for Behind the scenes throughout 2018, the CDISC CDISC Library was designed to become the single the Blue Ribbon Commission, CDISC leadership interactive tools and an easy-to-use learner portal Data Standards Catalog and the PMDA’s Data review with membership access. Data Science team, under the leadership of Dr. source of truth for CDISC standards. It represents a decided to rename CDISC SHARE as CDISC Library integrated with the CDISC website. Standards Catalog. Classroom training is available Sam Hume, developed the new CDISC Library. significant investment of time and money to reduce at launch, to align with our new branding and to across the globe, in multiple languages, and CDISC Library, at launch, will be a first-in- recognize the significant improvements and taught by our authorized instructors. class metadata repository (MDR) to include new capacities in the MDR. CDISC continued In 2018, more than a new API, an expanded metadata model, to update and expand the offerings of CDISC Public Training 90 Your Electronic Your Clinical and new standards content with additional Systems SHARE Exports, renamed CDISC Library Opportunities to attend CDISC Public Training subject matter experts levels of granularity and features previously System Archives, throughout the year. CDISC Library sessions occur in a variety of locations throughout unavailable. Mobile Health Archives, available to all members, provides the year. A convenient way to join us for Public provided CDISC Education Apps & Gadgets CDISC standards metadata available for Training is to attend a CDISC Interchange, where CDISC Library uses a new linked data download in a variety of electronic formats. multiple classes are available before and after the technology stack. Over the year, the Data In addition to the standards and controlled event. content via 201 events to Science team transformed all existing Web terminology metadata files, CDISC Library metadata into formats compatible with Browsers Archives provides access to novel metadata 5,553 learners across the new system. This work included sources such as Diff (Difference) files and representing more than 1 million metadata therapeutic area metadata. 36 countries! elements, linked via 6 million relationships. Data Validation The team also continued to develop tools Tools & Services CDISC staff benefited from our partnership that the Standards Development Teams can with Nurocor to develop and launch CDISC Workshops use to expedite standards’ availability. Internal and External Library and the thought leadership provided Repositories by Nurocor staff members Frederik Malfait CDISC Workshops bring in elements to ground Throughout the year, the CDISC Data Science and Barrie Nelson. participants in a variety of topics, from the team held workshops at Interchanges and fundamentals of standards used to connect periodic webinars to inform the community At the end of 2018, President and CEO David The clean design of the CDISC LMS the heterogeneity of standards implementations. healthcare and research and to sessions covering of the many benefits of CDISC Library and its R. Bobbitt announced the CDISC Library API would interface was designed for ease of use. CDISC is committed to regulators and sponsors CDISC public and private training provide the latest advancement of CDISC’s technical ecosystem of tools as well as provide progress be available to all CDISC members at no additional learning and networking opportunities. attaining the full benefit of standardization. Online Classes releases, such as our Library program. updates toward Library’s next iteration. The charge as a benefit of membership. CDISC The API allows real-time access to standards Each webinar is led by a CDISC expert and designed team and colleagues also published the article leadership is developing new, simplified EULAs Convenience is the key to taking online classes Private Training in a variety of formats (JSON, XML, Excel/CSV) increase knowledge and improve workflow. “CDISC SHARE, a Global, Cloud-based Resource (End User License Agreements) that encouraged through CDISC. Class offerings cover the for programmatic use by developers to create On-site training is an ideal opportunity to get of Machine-Readable CDISC Standards for Clinical open source and commercial software developers complete range of clinical data standards topics CDISC metadata libraries within their metadata multiple staff members up to speed on the clinical and Translational Research” in the American to develop products using the API. and new and updated content is always just a repositories, support CDISC standards in electronic data standards that are specifically important Medical Informatics Association Joint Summits on click away. Plus, CDISC’s new LMS system keeps case report forms, and use within clinical research track of your progress. to your organization - all in the comfort of your Translational Science Proceedings. offices or the location of your choosing. 10 Clear Data. Clear Impact. 11 Interchanges & Events Interchanges & Events

CDISC holds global events annually on three continents with hundreds of attendees gathering to network, share their expertise, best practices, and lessons learned about implementing CDISC standards to bring efficiencies and clarity to data.

Europe | Berlin, Germany Japan | Tokyo | 10 - 11 July 2018 23 – 27 April 2018

“Well organised with many interesting tracks and inspiring speakers.” “The speakers were very clear, and it was easy to understand common issues.”

China | Beijing | 6 – 7 September 2018 US | Bethesda, Maryland 10 – 11 October 2018

“The conference had opportunities to share experiences, process “Great job. Very engaging topics – probably the best Interchange that improvements and innovations.” I’ve been to in terms of content.”

Highlights of 2018 95% of survey respondents state • Launched New Branding at US Interchange that they would recommend CDISC • Regulator panelists included US FDA, Japan PMDA, China NMPA, and EU EMA Interchanges to others!

12 Clear Data. Clear Impact. 13 Alliances CDISC Rebrand

New Look, New Experience The background pattern found throughout CDISC is driven by the belief that the true CDISC’s website, emails, and collateral continues measure of data is the impact it has. We enable CDISC is not an island. Our impact as an organization is multiplied by In 2018, CDISC embarked on an ambitious project the theme of collective power (the CDISC the accessibility, interoperability, and reusability our collaborations with our global partners. Through partnership, we to improve user experience through a redesigned community) and the framework for generating of data, helping the entire field of clinical research can continue to advance interoperable standards across a wide range of website and complete rebrand which were both and connecting clinical research data. tap into—and amplify—its full value. From greater ready in time for an exciting launch at the 2018 US efficiency to unprecedented discoveries, we make therapeutic areas so greater clarity is achieved, more powerful research Interchange in Bethesda, MD. Both projects took it possible to turn information into invaluable is conducted, and more meaningful connections are discovered. And The Leona M. and Harry B. Helmsley Charitable diligent effort from all areas of the organization. impact for clinical research and global health. Trust committed $5.4 million in funding to CDISC as our dedication and collaboration continue to grow, so too will our to support work to standardize clinical data to A New Look for CDISC.org collective impact on global health. ease data sharing among research scientists and As a leader in global standards development, it is to improve medical research around the globe. important for CDISC to make information regarding A few of our key partners and collaborative efforts over the year are Helmsley’s support will enable CDISC to create clinical data standards and our array of services, highlighted here: data standards for type 1 diabetes (T1D) and education, and event opportunities easily accessible Crohn’s disease (CD) research, building CDISC’s for our current and prospective members and infrastructure, tools, and training for academic volunteers. The 2018 release of the updated and researchers. In time, these interoperable data rebranded CDISC website helped in this effort by providing our community with the most accurate, The Critical Path will foster better medical decision-making, drug I Institute (C-Path) is a discovery, and healthcare for T1D and CD patients up-to-date information about our shared knowledge nonprofit, public-private worldwide. Benefitting both the T1D and CD David R. Bobbitt and Nicole Harmon launch the CDISC re-branding and expertise in the field clinical research. initiative. Dr. Harmon led the rebranding initiative, which developed partnership with the FDA created under the NCI EVS is a founding partner in the development, communities, the new CDISC standards will allow from workshops and interviews with staff members, volunteers, and auspices of the FDA’s Critical Path Initiative maintenance, and production of Controlled for more seamless information sharing across the Board of Directors. program. C-Path’s mission is to catalyze the Terminology content, tools, and services to research centers, improve the quality, usefulness, development of new approaches that advance accurately code, analyze, share, and integrate and consistency of clinical data, and support New CDISC Look, Consisting of Logo, Pattern and Tag Line Clear Data. medical innovation and regulatory science, clinical, translational, and public health data for the evaluation of the effectiveness of emerging accelerating the path to a healthier world. CDISC cancer research and other biomedical fields. CDISC treatments. The significance of the new logo Clear Impact. and C-Path long-standing collaborations have and NCI EVS work together to create Controlled and pattern Helmsley’s commitment also enables CDISC to resulted in the development of over 30 Therapeutic Terminology that is linked to other common “Clear Data. Clear Impact.” The new CDISC tag continue following time-tested, consensus-based The geometric, clean, and bold typographic Area User Guides. research semantics through EVS tools for CDISC line, concisely relays that in the ever-evolving processes to consolidate and transform standards element of the logo supports the brand essence, Foundational and Therapeutic Area Standards. and complex clinical research landscape, CDISC into real-world-data compatible standards, and “Clear Data. Clear Impact.” The logo’s dots NCI EVS is an active participant throughout provides critical clarity by developing and CDISC and PhUSE PhUSE ensure optimal data quality, validity, and use. represent planning, collection, organization, and CDISC’s global community, providing subject advancing data standards of the highest quality partner to further the Once harmonized and accessible via open-source analysis, the four clinical research data points. matter expertise on many steering committees to transform incompatible formats, inconsistent mission of each organization, and web-based tools, the transformed standards These dots are integrated with the letters of to implement strategic goals. CDISC and EVS methodologies, and diverse perspectives into with CDISC focusing on will help researchers who are not experts in data CDISC to convey the idea that our Standards released four quarterly Controlled Terminology a powerful framework for generating clinical developing global, platform-independent data standards build clinical datasets that can be are interconnected and interoperable. Aligned Our goal with the new website was to provide our packages in 2018. research data that is as accessible as it is standards, and PhUSE focusing on implementing shared with others. This, along with educational horizontally they suggest the collective power and visitors an easier way to learn about standards illuminating. CDISC standards. PhUSE is CDISC’s preferred support, aims to promote ethical data sharing. forward thinking of the CDISC global community. and to browse information based on their areas partner for implementation questions and issues. of interest. We believe that the new website gives better access to who we are and how we work in a global environment. 14 Clear Data. Clear Impact. 15 Membership Membership

Throughout history, groups have come together to achieve benefits far greater than anything they’d be able to accomplish solo. CDISC, through our member organizations, brings together like- Proud minded individuals so they can enjoy the benefits of a larger presence. In the end, the more people who come together, the more possibilities exist to find solutions that reduce human suffering. Clear Data. Clear Impact. Member

CDISC Member Benefits Membership by Industry Membership by Country • Significant Discounts on Training and Japan CDISC Interchanges United States China Germany France United Kingdom Belgium Canada • Exclusive Access to CDISC Library and CDISC Library Archives • Credit for Online Training Courses 49% 11% 5% 5% 4% 4% 3% 3% • Free Monthly Members-Only Mini Training Webinars Academic Institution – 7% CRO - 34% Nonprofit Organization – 5% Biotechnology – 4% • Postings on the CDISC Industry Job Board • Unlimited access to the Members Only Area • Community Growth • Plus MORE! Government – 2% Pharmaceutical – 17% Clinical Laboratory - 0.2% Healthcare Provider - 1% CDISC Standards and related innovations would not be possible without the dedicated volunteer Denmark Switzerland South Korea India Ireland Spain Sweden All Others efforts and financial assistance of our member organizations. Our members’ support ensures Technology Service Consulting – 6% Medical Device – 0.7% Other – 3% standards remain open and free, Provider – 20% 3% 3% 2% 1% 1% 1% 1% 5% and that they are sustainable into the future. We sincerely appreciate the continuing support and advocacy of our members. By working together, we will achieve CDISC serves 16 industry segments and has 457 member organizations globally! the CDISC mission.

16 Clear Data. Clear Impact. 17 PLATINUM MEMBERS DXC Technology ** National Library of Medicine GOLD MEMBERS Chonbuk National University Hospital Fred Hutchinson Cancer Research Center * MMS Holdings, Inc.** Statistics and Data Corporation ** CHU Sainte-Justine Frontier Science ** Mosim Co., Ltd. Sucampo Pharmaceuticals, Inc. * eClinical Solutions, LLC * New York University School of Medicine A2 Healthcare Corporation * ClinDART, Inc. GCE Solutions Multi-Regional Clinical Trials Center at Sycamore Informatics AC Medical, Inc. * Clindata Insight Inc. GCP-MB Harvard SymBio Pharmaceuticals Limited AbbVie ** EDETEK Inc * Next Step Clinical Systems LLC * Acceleron Pharma ClinData International * GCP-Service International Ltd. & Co. KG * Nagoya Medical Center * SyMetric 1mdata Eisai, Inc. ** Novartis Pharmaceuticals Corporation *** Accord Research s.r.o. ClinDatrix, Inc. Genmab A/S Navitas * Syne qua non Limited * ACI Clinical ** Clinical Solutions Group (CSG), Inc. Genomedia Inc. Nestle Clinical Development Unit * Synteract * Absolute Systems Clinical Data * Eli Lilly and Company *** Novo Nordisk ** aCROnordic ** Clinical Trials Statistical and Data Gossamer Bio Neurocrine Biosciences, Inc. Syreon Corporation Accenture, LLC * EORTC * Novum Pharmaceutical Research Services Acumen Information & Technology Co., Management Center at the University Grunenthal GmbH ** Nippon Shinyaku Co., Ltd. Systex, Inc Ltd. of Iowa Grupo Español de Investigación en Cáncer Nordic Bioscience A/S Taisho Pharmaceutical Co., Ltd. Acorda Therapeutics, Inc * ERT Pharmaceuticals ** Nurocor AdClin * CliniOps, Inc. de mama (GEICAM) Novotech Pty Ltd. * Takumi Information Technology Inc. * Akana * F. Hoffmann-La Roche Ltd ** Ono Pharmaceutical Co., Ltd. Advance Research Associates, Inc. * ClinStat GmbH H. Lundbeck A/S ** NRG Oncology Foundation TalentMine, LLC * Advanced Clinical ** Clinvest Research H2O Clinical, LLC * Nubilaria Srl Tamr Alexion Pharmaceuticals * Food & Drug Administration Oracle Corporation * Agati Clinical Informatics CMIC Holdings Co. Ltd. ** Halozyme Therapeutics, Inc. Nuventra, Inc. TCell Clinical Services Akros Pharma, Inc. * Cognigen Corporation Hands-on GmbH ** OCS Life Sciences * TechnoSTAT Ltd. Altria Forte Research Systems, Inc. ** Otsuka Pharmaceutical Development and Algorithme Pharma Cognitive Research Corporation * Health Decisions Omeros Corporation * TELEMEDICINE TECHNOLOGIES S.A.S Amgen *** Fujitsu Limited * Commercialization, Inc. ** ALK-Abello A/S Commonwealth Informatics Health Level Seven ** OmniComm Systems ** Texas e-Health Alliance * Alkermes Corcept Therapeutics Helsinn Healthcare SA ** Orion TFS ARO Council Gilead Sciences ** PAREXEL *** Allergan ** Cota Enterprises, Inc. HERAX * Oy 4Pharma Ltd The EMMES Corporation * Asahi Kasei Pharma Corporation GSK *** Pfizer, Inc. *** Almirall, S.A. * CPC Clinical Research * HIMSS ** P1vital Products Ltd The Griesser Group Alnylam Pharmaceuticals CR Medicon US, Inc. HMS Analytical Software GmbH PCG Solutions AB Theradex Oncology Ashermed IBM ** Pharmaceuticals & Medical Devices Agency Alpha Clinical Systems CRC Pharma * Hua Medicine, Inc. PDS Life Sciences * Therapeutics, Inc. * Astellas Pharma, Inc. ** ICON Clinical Research ** Philip Morris Products SA * American Medical Informatics Association CROMSOURCE * Hurley Consulting Associates * Peachtree BioResearch Solutions TMF - Technology, Methods, and (AMIA) ** CROS NT s.r.l. * ICRC-Weyer GmbH * PEGUS Research Inc. * Infrastructure for Networked Medical AstraZeneca AB ** Incyte Corporation Pinnacle 21 LLC. ** Amphastar Pharmaceuticals Inc * Cross Metrics SA * IDDI ** PerkinElmer Research ** ASKA Pharmaceutical Co., Ltd. CRS Clinical Research Services Mannheim InClin, Inc. Pharm-Olam International Ltd. Toray Industries, Inc * Baxter Healthcare Corporation ** Innovative Medicines Initiatives * PointCross Life Sciences, Inc. ** ASKLEP Inc. * GmbH * Innovative Analytics Inc. Pharma Medica Research Inc. * Toyama Chemical Co., Ltd. * Bayer Pharma AG ** Innovion BVBA PPD *** Assero Limited ** CSL Behring * Instat PharmaStat LLC ** TradeCraft Clinical Research Assign Data Management and Biostatistics CTEP (RealWorldEDC) Ltd ** Instem LSS ** Precursor Trial Data Pharmaceutical Technology BeiGene, Inc. Institut de Recherche Pierre Fabre * PRA Health Sciences ** GmbH CTTI ** Institut Jules Bordet, The BrEAST Group * Profil Institut fuer Stoffwechselforschung (Shanghai) Co., Ltd. Bioclinica, Inc.** IQVIA *** Premier Research Group *** Association of Clinical Research Cytel, Inc. ** Institut Paoli-Calmettes ** Trium Analysis Online GmbH * Organizations * Dacima Software Inc intellim Corporation Progenics Pharmaceuticals Ultragenyx Pharmaceutical Biogen Idec, Inc. ** Japan Agency for Medical Research and PROMETRIKA, LLC * ATLANSTAT Data MATRIX, Ltd. iOMEDICO AG Prothena Biosciences Inc. United BioSource Corporation ** Boehringer Ingelheim Pharmaceuticals *** Development QST Consultations, Ltd ** Atlant Clinical Ltd. Data Standards Decisions Aps Ionis Pharmaceuticals, Inc. * Protocol First, Inc. University Hospital Medical Information Axio Research LLC ** DataDriven, Inc. IPSEN Innovation ** PSI CRO AG Network ** Bristol Myers Squibb *** Jazz Pharmaceuticals, Inc. * Quality Data Services, Inc. ** AXIODIS DATAMAP GmbH Jiaxing Taimei Medical Technology Co., Ltd Puma Biotechnology, Inc. University of California, San Diego * Basilea Pharmaceutica International Ltd. ** Datametrix Juno Therapeutics Purdue Pharma L.P. ** University of Luxembourg Business & Decision Life Sciences ** JDRF Sanofi *** Battelle Memorial Institute Datavant KAI Research, Inc.** Quadratek Data Solutions * University of Michigan Celgene Corporation ** Johnson & Johnson *** Santen, Inc. * Becton Dickinson Deloitte Consulting, LLC * Kaiser Permanente Quanticate International Ltd * University of Tsukuba * Beijing Bioknow Information Technology Densuke Systems Co. Ltd. Kanazawa University Quartesian LLC * University of Utah - Center for Clinical and Center for Biostatistics in AIDS Research JSS Medical Research Sarah Cannon Development Innovations (SCDI) * Co., Ltd. DF/Net Research, Inc. * Kantar Health Quinta - Analytica International, s.r.o. Translational Science Centers for Disease Control / National Center for LinkDoc Technology (Beijing) Co., Ltd. SAS ** Beijing Data Science Express Consulting DIcore Group, LLC * Karmic Lifesciences LLP Quotient Sciences UniWeb Co., Ltd DOT WORLD CO., LTD. * KCR Quretec, Ltd. Uppsala Clinical Research Center * HIV/AIDS, Viral Hepatitis, STD and TB Prevention LLX Solutions Servier * Beijing Huayi Internet Technology Co., Ltd. DP Clinical * KCT Data, Inc. R-Square, Inc. * Uppsala Monitoring Centre * Certara *** Lung Biotechnology, Inc. SGS ** Beijing Improve-Quality Technology Co., DSG, Inc. * Keyrus Biopharma Rakuten Aspyrian, Inc. US Army MRMC ** Ltd. Duke Clinical Research Institute *** KOEHLER eClinical GmbH ** Ratilan Technologies, Inc. Venn Life Sciences Chiltern LYSARC Shionogi & Co., Ltd * Beijing Trust Medical Consulting Co. Ltd. DZS Clinical Services Kyoto University Hospital * RCTs Veristat, Inc. ** Bell Medical Solutions, Inc *. e-Trial Co., Ltd. * Kyowa Hakko Kirin Co., Ltd. REGENXBIO Vertex Pharmaceuticals ** Clinipace * Massachusetts General Hospital - CIB Shire Pharmaceuticals, Inc.* Bioforum Ltd. * EA Pharma Co., Ltd. Kyushu University Hospital * Relypsa Vita Data Sciences, a division of Softworld CLUPEA, Inc. Massachusetts Veterans Epidemiology Research Sumitomo Dainippon Pharma Co.,Ltd ** BioMarin Pharmaceutical Inc. ** Edgerton Data Consulting, LLC. La Jolla Pharmaceutical ResearchPoint Global Inc. BioOperations Consulting Edwards Lifesciences LLC Lab Data Solutions Rho, Inc.** Wake Forest Baptist Medical Center Cohen Veterans Bioscience and Information Center ** Syneos Health Inc. * Bioskin GmbH * Elevada Lambda-Plus SA * Robarts Clinical Trials Westat CompleWare Corporation *** McDougall Scientific Ltd. ** Takeda Development Center Americas, Inc. *** BioStata ApS * Eliassen Group ** Larix ApS * Robertson Centre for Biostatistics * Winicker Norimed GmbH * Biotrial Biometrics * Elligo Health Research LATIS SRL RTI International World Programming * Covance ** Medidata Solutions Worldwide ** Target Health, Inc. ** bluebird bio EMB Statistical Solutions, LLC * LEO Pharma A/S * S-cubed ApS ** Worldwide Clinical Trials * Critical Path Institute ** Medtronic, Inc. * The Helmsley Charitable Trust Blueclinical, Ltd. Ennov Clinical Lincoln & Aixial, the Alten CRO Sage Therapeutics X-act Cologne Clinical Research GmbH * Bogier Clinical & IT Solutions, Inc. Entimo AG ** Linical SAM GmbH * Xinghui Medtech (Shanghai) Co. Ltd. CRScube Inc. Mel Consulting The University of Tokyo Hospital Bracket Ephicacy Consulting Group, Inc.* LSK Global Pharma Services Samvit Solutions, LLC * Xiyuan Hospital of China Academy of Brightech International LLC * EPS Corporation * M.E.D. Technical Consulting SanaClis s.r.o. Chinese Medical Sciences d-wise Technologies ** Merck & Co., Inc. *** Theravance Biopharma, Inc. ** C&R Research ethica CRO MacroGenics, Inc. * Sanford Health XML4 Pharma ** Daegu Catholic University Medical Center * Merck KGaA ** Triangle Biostatistics, LLC CAC Croit Corporation * European Clinical Research Infrastructure MacroStat (China) Clinical Research Co., SCiAN Services Inc. * Xybion Corporation * Cambridge Semantics Network Ltd Science37 Zifo RnD Solutions * Daiichi Sankyo, Inc. ** Mitsubishi Tanabe Pharma Corporation ** Trifecta Clinical * Cancer Insight, LLC Evado Clinical Softwaren * Maruho Co., Ltd. SCSK Corporation Danone Nutricia Research Montreal Health Innovations Coordinating Center UCB Biosciences, Inc. ** Cancer Research And Biostatistics * Everest Clinical Research * MaxiVAX SA Seattle Children’s ** Capish Nordic AB * Exelixis, Inc. * Medical Excellence Inc. Seattle Genetics DataCeutics, Inc ** National Cancer Center * University of Oxford Cardiovascular Clinical Science Foundation eXYSTAT MedicalLogic Co., Ltd. Senju Pharmaceutical Co., Ltd. Deep Intelligent Pharma Co., Ltd. National Cancer Institute * University of Southampton Clinical Informatics Ce3, Inc. * Fast-Track Drugs & Biologics, LLC * Mediqual-Sprl Seven to One, Inc. CEBIS International Ferring Pharmaceuticals ** MEDISCIENCE PLANNING, Inc. SHYFT Analytics Digital Infuzion ** National Institute of Allergy & Infectious Diseases Research Unit Center for International Blood and Marrow Fiverings Co., Ltd. MedNet Solutions ** Signifikans Aps Transplant Research FMD K & L, Inc. * Medpace, Inc. * Simbec Research Ltd * dMed Biopharmaceutical Co., Ltd. (NIAID) Xclinical ** Center for Public Health Informatics ForceClouds Software Co., Ltd. Metronomia Clinical Research GmbH * SimulStat Incorporated Center of Excellence for Biomedical and Formedix USA ** MiMedx Sinyoo Information Technology Co. Ltd. Public Health Informatics * Foundry Health MKS Incorporated * StatisticaMedica *** CDISC Charter Members ** Member for over 10 years * Member for over 5 years *** CDISC Charter Members ** Member for over 10 years * Member for over 5 years

18 Clear Data. Clear Impact. 19 Milestones 2018 Standards Releases

The Helmsley Charitable Trust China National Medical Products Administration SDTM v1.7 Therapeutic Area User Guide – Huntington Disease The Leona M. and Harry B. Helmsley HUNTINGTON'S The Huntington’s Disease Regulatory Science Consortium In 2018, CDISC released SDTM v 1.7, which describes the general DISEASE Charitable Trust provided $5.4 CDISC Increases Interactions with China National Medical conceptual model for representing clinical study data submitted (HD-RSC), launched in March 2018 by the Critical Path Institute million in funding to CDISC in 2018, Products Administration to regulatory authorities. SDTMIG v3.3 provides specific domain (C-Path) and CHDI Foundation, along with the CDISC, provided supporting work to standardize the open availability of a newly developed Huntington’s Disease Therapeutic CDISC executives David R. Bobbitt, Peter Van Reusel, and Sheila Leaman had models, assumptions, business rules, and examples for preparing standard clinical data to ease the process of Area User Guide (TAUG-HD). The guide was developed to describe the a productive meeting with officials in Beijing at the offices of the Center for tabulation datasets that are based on the SDTM. data sharing among research scientists and to improve medical research most broadly utilized clinical concepts for data acquisition and analysis in Drug Evaluation (CDE), which is part of the China National Medical Products Huntington’s disease (HD) clinical studies using the CDISC standard format. around the globe. Administration (NMPA) during the week of the China Interchange. Later in The user guide defines parameters for data collection and allows datasets the fall, Special Advisor to the CEO, Dr. Steve Wilson, represented CDISC SDTMIG v3.3 from different sources to be compared or combined for sharing and analysis. Peter Van Reusel Named Chief Standards Officer at a meeting of Chinese stakeholders organized by NMPA to discuss how Along with the release of SDTM v1.7, CDISC released SDTMIG adoption of global data standards helps meet the needs of the Chinese v3.3, which provides specific domain models, assumptions, In 2018, CDISC named long-time standards advocate, skilled people to grow domestic pharmaceutical discovery and manufacturing. business rules, and examples for preparing standard tabulation Therapeutic Area User Guide – PTSD instructor, and European Liaison, Peter Van Reusel, as the datasets that are based on the SDTM. organization’s Chief Standards Officer. PTSD CDISC and Cohen Veterans Bioscience collaborated to New Online Learning Management System Released establish a new CDISC Therapeutic Area Data Standard for Peter brings over 20 years’ experience in senior roles in pharma CDISC continued to invest in technology and tools to enhance post-traumatic stress disorder (PTSD). and at CROs, leading the development and implementation of Glossary v12.0 implementer experience as well as help our community unlock CDISC standards and carrying out other standards work in a multitude of Glossary v12.0 included a more robust and frequently used The CDISC and Cohen Veterans Bioscience collaboration maps the the benefits of data standardization. One such improvement organizational settings. He has been a CDISC-authorized instructor for over request process for new terms since Glossary activity is better most common data elements and biomedical concepts used in PTSD to was launching a new learning platform to access our authorized online 11 years, and has helped significantly in developing CDISC training courses. integrated into Controlled Terminology to support the exchange establish uniform clinical research and terminology standards. This will be training courses. The new platform features: For the past two years, Peter has served as CDISC’s European Liaison, of digital information. accomplished by collecting, tabulating, analyzing and then standardizing data for PTSD medical research and clinical care, collected within the US shepherding relationships with key European regulatory, academic, and • Interactive tools that foster active and engaging learning The team updated about 50 existing terms, reviewed close to 100 new National Institutes of Health, Department of Defense, Veterans Affairs and biopharma stakeholders. He is also an active PhUSE working group leader. • Assessment diagnostics to monitor your progress as you go terms, and updated or added more than 150 acronyms/abbreviations/initials other key organizations. • Ease of enrollment with the capability to register a team of any not included in 2017. In addition, sources for definitions from new guidelines US FDA CDER Requires Medical Reviewers to size quickly are provided as a tab for ease of use in the Excel file. Therapeutic Area User Guide – Vaccines Complete Competency in CDISC Standards • Full integration with the CDISC website, allowing single sign on Completing competency in CDISC Standards, among other Therapeutic Area User Guide – Colorectal Cancer VACCINES Version 1.1 of the Vaccines Therapeutic Area User Guide (TAUG- Vax) was developed under the CDISC Standards Development competencies, is required for reviewers to move from Level COLORECTAL Colorectal cancer is the second most commonly occurring CANCER Process and describes the most common biomedical concepts 1 (Associate) Medical Reviewer to Level 2 (Career Conditional) Medical cancer in women and third most commonly occurring relevant to vaccines, and the necessary metadata to represent such data Reviewer. cancer in men, according to the World Cancer Research Fund North America consistently with Terminology and SDTM. Atlantic | San Diego | Bay Area | Boston | Midwest | Delaware Valley | Heartland | Raleigh | Seattle | Washington D.C. International. There were over 1.8 million new cases in 2018. Europe English | French | German | Italian Version 1.0 of the Colorectal Cancer Therapeutic Area User Guide (TAUG- Asia CDISC India User Group Launches China | India | Japan CrCa) was developed under the CDISC Standards Development Process and Africa India User Network With mounting clinical research skills and passion in India, South Africa describes the most common biomedical concepts relevant to Colorectal a CDISC User Group was launched in 2018 to serve as a support system to Cancer and the necessary metadata to represent data consistently with connect and keep up with the fast-paced industry in the country. CDASH, SDTM, and ADaM.

20 Clear Data. Clear Impact. 21 2018 Financial Information 2018 Financial Information

2018 Income vs. Expenses Long-term Growth

CDISC experienced strong growth in 2018, with revenue increasing by 8% over 2017. This dynamic performance was driven in particular by a strong support This strong growth has allowed us to significantly increase our net revenue for 2018, ensuring the long-term sustainability of our mission. Our internal from our community, as evidenced by the increase in membership and above all project funding. organization was also significantly remodeled, and our staffing increased, particularly in the standards and data science teams. The impact of these changes has already been positively felt, and we expect this to continue as we advance several key projects in 2019.

$9 M 2018 Income 2018 Revenue

Income Financial History $8 M Education $1,336,000 16% Standards Development/ Events $730,000 9% Library 30% Standards Development / Library $2,509,000 30% $7 M Membership Membership $3,759,000 44% Events 44% Income Expense Other $84,000 1% 9% Gross Income $8,418,000 Education $6 M 16%

Other $5 M 1%

2018 Expenses $4 M 2018 Expenses Expenses IT / Finance / $3 M Education $1,169,000 14% Admin / Other Education Events $853,000 11% 19% 14% Standards Development / Library $3,383,000 41% Communication Events $2 M 11% Alliances & Business Development $430,000 5% 6% Membership $276,000 4% Membership 4% Standards $1 M Communication $492,000 6% Development / Alliances & Business Library IT / Finance / Admin / Other $1,572,000 19% Development 41% Total Expenses $8,175,000 5% $0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018

22 Clear Data. Clear Impact. 23 CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data.

With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization and is headquartered in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world.

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