. . . with collaboration there is strength.

TEAMWORK

C D I S C 2 0 1 2 A n n u A l R e p o R T

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Dear CDISC Members and Supporters:

Strength through Collaboration has driven CDISC

activities since our earliest volunteer-only days, and this

motto has become increasingly meaningful over the 16

years we have been in existence. This strength grows

daily through the partnerships we have developed

with other organizations and the CDISC team members

and volunteers, who work tirelessly to develop global

standards to streamline clinical research. In the spirit

of these volunteers and teams, we determined that the

appropriate theme of this year’s CDISC Annual Report

is teamwork. The CDISC teams, their leaders and their

important and useful products are highlighted in the

following pages.

In addition to collaborations for standards development,

there are now clear examples of how global data

standards are essential to productive research

collaborations among organizations around the world

– whether the research is for interventional trials for

product approval of new therapies, basic academic

research or translational research. One of our CDISC

Board members, who is from a major academic

institution, recently commented that collaborations

are now strongly encouraged in research and, since it

is not always clear at the onset of a research study who

a researcher will partner with, it is best to use global,

open clinical research standards (i.e. CDISC standards).

In other words, we are stronger through collaborations

and Standards Enable Collaboration.

With the volume of information now available through

genomics and electronic health records, conducting

research the way I used to do it – writing data in a bound

notebook and not sharing it beyond the laboratory walls

until there was a publication – is no longer a viable option.

Collaboration and teamwork are now essential. In the

standards development arena, the best standards result

when there are the most contributors. Building consensus

among numerous parties is not easy, but CDISC has been

called a catalyst for productive collaboration. CDISC

excels in convening individuals spanning the healthcare

continuum to develop global, open, consensus-based

medical research data standards. As in any project, just

like in sports, players should refrain from doing work that

is not contributing to the benefit of the team; in terms of

standards development, this includes the development of

one-off/proprietary standards or redundant/competing

standards. We must all cooperate and be team players

if we are going to work toward the shared goal of

accelerating the translation of data/information into

knowledge that can more rapidly benefit patients who

need new and better therapies; this is the theme of our

work with the Learning Health Community.

Although CDISC has offered for over 5 years a

harmonized foundational set of standards that apply

across all clinical research protocols, we now have new

opportunities for collaboration. Looking toward 2013,

CDISC will continue to develop CDISC partnerships,

launch new teams and work with new partners to

develop additional therapeutic area standards that

president’s letter

“Unity is strength… when there is teamwork and collaboration, wonderful things can be achieved.”

CONTENTS

2 President’s Letter

3 CDISC Vision & Mission

4 CDISC Principles, Values & Strategic Goals

5 CDISC History & Standards

6 The CDISC Timeline

8 Our Global Organization

9 2012 Milestones

10 Teams, Global CDISC Coordinating Committees & User Groups

12 2012 Collaborations

13 CDISC Education & Membership Benefits

14 2012 CDISC Membership

15 2012 Communications

16 2012 Financial Information

17 CDISC Leadership

19 CDISC Staff

20 The CDISC Team Roster

— Mattie Stepanek, age of 14, died from muscular dystrophy.

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CDISC Vision & Mission

CDISC is a 501(c)(3) global non-profit charitable

organization, with over 300 supporting member

organizations from across the clinical research and

healthcare arenas. Through the efforts of volunteers

around the globe, CDISC catalyzes productive

collaboration to develop industry-wide data standards

enabling the harmonization of clinical data and

streamlining research processes from protocol through

analysis and reporting, including the use of electronic

health records to facilitate the collection of high quality

research data. The CDISC standards and innovations

can significantly decrease the time and cost of medical

research and improve quality, thus contributing to the

faster development of safer and more effective medical

products and a learning healthcare system. CDISC

standards are vendor-neutral, platform-independent

and freely available via the CDISC website.

augment the foundational CDISC standards. We

are also working on better ways to share and

access these standards by enhancing semantics

and infrastructure. This brings to mind a story

from when we were working on this branding

several years ago. Another CDISC Board member

commented that the word collaboration, when

translated into French, is not always construed in

a positive sense. This exemplifies the importance

of semantics, which are the basis of BRIDG and

SHARE. Context and language are extremely

important when developing standards, to ensure

that computers can exchange data/information

and preserve their meaning and integrity. The

word teamwork may be more appropriate than

collaboration in this instance!

We could never have accomplished what CDISC

has achieved without our organizational members,

partners, team leaders and team members, Board

members and coordinating committees from

around the world. Patients (each and every one of

us) will be forever grateful and unable to express

this adequately.

Respectfully,

Rebecca D. Kush, PhD; Founder, President and

CEO, CDISC

The CDISC Vision is to inform patient care and safety through higher

quality medical research.

The CDISC Mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve

medical research and related areas of healthcare.

Vision

Mission

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The CDISC values below were developed by

CDISC Operations between December 2008

and April 2009. They represent CDISC Business

Ethics and are based on the principles from

the Economy of Communion (EoC), which

inspires a “culture of giving” versus a “culture

of having.”

The CDISC core value is to foster an

understanding that the CDISC community is

an altruistic organization contributing to the

advancement of global healthcare.

CDISC principles CDISC Values

The CDISC Core Principles are:

1. Lead the development of standards that

improve efficiency while supporting the

scientific nature of clinical research.

2. Recognize the ultimate goal of creating

regulatory submissions that allow for

flexibility in scientific content and are easily

interpreted, understood, and navigated by

regulatory reviewers.

3. Acknowledge that the data content, structure

and quality of the standard data models are

of paramount importance, independent of

implementation strategy and platform.

4. Maintain a global, multidisciplinary, cross-

functional composition for CDISC and its

working groups.

5. Work with other professional groups to

encourage that there is maximum sharing

of information and minimum duplication of

efforts.

6. Provide educational programs on CDISC

standards, models, values and benefits.

7. Accomplish the CDISC goals and mission

without promoting any individual vendor or

organization.

• Continue to refine, support and educate on existing/

foundational CDISC standards, achieving significant

progress in the use of CDISC standards to streamline

research, build quality into the beginning of the

research process and promote scientifically sound

data aggregation for the purposes of scientific

investigation, comparative effectiveness and patient

safety.

• Expedite the development and rollout of new

therapeutic area standards to ensure consistency

in data capture and analysis related to efficacy in

addition to patient safety.

• Achieve significant progress in enabling

interoperability between clinical care and clinical

research and explore expansion from bench to

bedside (translational research); accelerate the cycle

through which healthcare informs research and

research informs clinical decisions.

• Develop CDISC SHARE, a global, accessible,

electronic library for CDISC content/semantics that

will enable precise and standardized data element

definitions and richer metadata that can be reused

within applications and across studies to improve

biomedical research and its link with healthcare.

• Leverage our global, nonprofit, vendor-neutral,

independent status to forge productive collaborations,

to communicate well and to provide value to key

stakeholder communities.

Strategic Goals 2013–2015

Business Leadership and Workers;

Work with Excellence

Relationships; Friendly, Professional Relationships;

Respect Others

Ethics; Mutuality –

No Separation between Individual

and Business Principles

Environment; Harmony with the Working

Environment; Organize Structures Harmoniously

Quality of Life and Production;

Work should be Balanced

Communications; Regular Company Updates;

Encourage Input Without Penalty

Development; Training and

Education; Mentor Lavishly;

Risk in New Ideas

4

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The Clinical Data Interchange Standards Consortium (CDISC) was initiated as a volunteer organization in 1997 and was incorporated as a non-profit organization in February 2000. In May of 2011, CDISC attained 501(c)(3) status, recognizing it as a charitable organization. Since 1997, teams of volunteers have ensured that efficient, consensus-based standards have been produced through the CDISC Standards Development process. The standards development process was updated in 2012 (having learned from the development of a number of therapeutic area standards) to an improved, accelerated process that is now being implemented. CDISC released its first production models in 2000 and has had a steady record of accomplishment ever since.

Why Standards? What Can Standards Do for Us?

The word standards brings up many different

connotations depending on who hears it and in what

context. The CDISC Standards are also quite varied

and serve different purposes individually. However, as

a cohesive and harmonized suite, they streamline the

medical research process, reducing time and costs and

other resources while improving quality. Without them,

we create silos and often have insufficient information

to draw meaningful conclusions. Without standards,

the simple becomes complex.

Here are some of the many benefits that users of global

industry standards for clinical research (CDISC) can

expect.

• Ensure that we live up to our promise to patients/

subjects who participate in research studies to

safeguard that their precious data will be used

appropriately

• Streamline research from protocol through analysis

and reporting

• Enable data aggregation for more robust and

knowledge-based databases

• Enable sharing of information from one entity to

another or one tool to another

• Decrease the time it takes to initiate a new research

study

• Improve data quality

• Improve team communications

• Allow a choice in tools/technology (as long as they

are standards-based)

• Enable the learning healthcare system where

research informs clinical care decisions and

healthcare data are used for ongoing research

CDISC History & Standards

Implementations Standards Semantics Data Exchange

TA Standards & Questionnaires

SHARE

Achieving Interoperability

ODMXML

k

ODMXML

k

ODMXML

k

Protocol

PRM

Study Design

Healthcare Link

Healthcare Link

RIM

Data Collection

CDASH

LAB

HEALTHCARE

PatientsTabulation& Analyses

ADaM

SENDSDTM

Submission/Publication Report

SDTM

SENDADaM

RESEARCH

BRIDG

BRIDG

Controlled Terminology

“Using CDISC standards is all about making the clinical trial process more efficient, saving time and money. [It is possible to have] significant content reuse, as much as 70-80% reuse in some cases, with 20% less maintenance cost. Our clients found as much as a 68% reduction in study set-up time, from 55% reduction in EDC build time, set to reach up to 80% this year, and a 76% reduction in the Study Conduct

and Analysis phase.”

–Mark Wheeldon, CEO of Formedix, a clinical trial automation software and services provider and CDISC Platinum Member.

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The CDISC Timeline

Modeling and Nomenclature Groups

> Glossary Group

Modeling>ODM (DAS) and SDS

ADaM andLAB Teams

SEND Team Protocol RepresentationGroup (CDISC-HL7)

Terminology Team; BRIDG Groups

100 MemberOrganizations

SDS v1.1

SDS v2.0; ODM v1.0; Glossary v1

(new versions annually thereafter

ODM v1.1 ADaM Models

Visits to Japan and Europe

ACRP and DIA provided venues

DIA SIAC on Standards

DIA SIAC changed to eClinical SIAC

(DIA cannot establish standards)

CDISC-HL7 Charter Agreement (CT-SIG);

renewal every 2 years

HL7 RCRIM replaces CT-SIG

CDISC Connectathon at DIA

CDISC Connectathon Single Source Pilot with

Duke et al.; FDA Pilot Project

Connectathonsand Pilot Projects

Collaborations

Globalization

CDISC Standards and Innovations

Teams

The Organization Non-profit incorporation 501c6(32 Charter Members)

5-year Anniversary(~ 150 member orgs)

LAB v1.1;ODM v1.2;SDTM v3.1

Courses in Australia

NCI-CDISC and IHE-CDISC

Collaboration begin

FDA Draft Guidance references SDTM,

SEND

Volunteer GroupInitiated

SDS v1.0 and ODM v0.8

LAB v1.0; SDTM v3.0; BRIDG Model Initiated

SEND 1.0; LAB V3 Message passed ballot

E3C Initiated J3C Intiated

Year 1997-1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

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CDASH Team and Streams; eSDI Group

Devices Team; SHARE Teams

Therapeutic Area Standards projects

10-year anniversary since incorporated, ~ 250 member orgs

ODM v1.3: LAB & SDTM Aligned; CDISC-IHE RFD

BRIDG v1.0, v1.1; BRIDG posted as open source

model

BRIDG v2.0, v2.1, v2.2 CDASH v1.0; eSDI

Document Published

SDTM v3.1.2; ADam v2.1 Imaging CRFs CDISC-IHE

RFD and RPE

Courses in Canada; India Interchange and courses

User Networks initiated in Europe (5 languages)

Courses in Brazil

Courses in China; RFD Training in Japan

South Africa initiates User Network

NIH Roadmap Grant with Duke – TB and

CV Projects

CDISC-IHE Quality, Research and Public

Health (QRPH)

ISO Liason A Status Awarded; ASTER

Launched

Critical Path Insti-tute/ CAMD–Alzhei-

mers; Tufts–PKD; ACC–CV disease

EMA cites CDISC eSDI requirements; SHARPn

Project with ONC/Mayo; JIC Leadership; Rockefeller/FDA

–Pain and Analgesics

Final FDA eCTD with SDTM and Define .xml

HIMSS Interoperability

Showcase

Healthcare Link Demo at CDISC Interchange; SEND

Pilot for FDA/CDER

Define.xml Implementa-tion Release (v1.0); SEND

v.2; ODM v1.2.1; SDTM v3.1.1;ODM mapped to HL7 RIM

HITSP: Use Case (EHRs for Core Research Data) – Clinical Research Tiger Team Initiated

Additional IHE Profiles Proposed (e.g. RPE); Greenway EHR-

Outcome Implementation of RFD

Courses in Thailand and Singapore

CDASH v1.1; SEND v3.0; Study Design XML v1.0;

C-Path MOU Signed; Gates Foundation-TB

SDTM/ADaM Pilot for FDA

K3C Initiated

IHE Connectathon Tests RFD; CDISC Life Sciences demo at HIMSS Interoperability

Showcase

CDISC accepted into Joint Initiative Council (JIC) for Global Harmonization of

Healthcare Standards

Protocol Representation Model (PRM) v1.0; BRIDG v3.0;

ODM v1.3.1; HHS-ONC/HITSP Interoperability Specification

#158; CDISC-IHE RPE

C3C Initiated

501c3 status (charitable) approved by US IRS;

CDISC Europe Foundation launched

CDISC-IHE-DIA EHRs for Clinical Research

Interoperability Showcase

Alzheimers Disease TA Package

Year 1997-1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

300 Member Mark Achieved; Austin Office Estab-lished; NIH/FDA Cardiovascu-

lar Imaging and Schizophrenia Grant Awarded

CFAST TA Standards Teams

To view all releases, please turn to page 10, the CDISC Teams page

10th Anniversary for CDISC Japan; CDISC Workshops with AmCham in China; WHO

Forum on Health Data Standardization and Interoperability; EMA Workshop

on Clinical-trial Data and Transparency; European Commission Projects Convergence

Round Table

Endorsed core values of the Learning Health System;

CDISC engaged in 3 IMI Consortia projects; NIH/FDA Grants; Leading role in JIC;

One Mind for Research Workshop

TRI (Japan) MOU Signed

IMI (Europe) MOU Signed

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Members,StakeholdersSupporters,

Adopters,and

Volunteers

About our Global organization

CDISCTeams

CDISC Board of Directors: The CDISC Board of Directors is made up of 12 members,

each serving a three-year term. Elections are held annually for vacant seats and

new members begin their terms on 1 January. The role of the Board of Directors is

to focus on the governing functions of the organization (functions that provide the

direction, resources and structure to meet its mission).

CDISC Advisory Council: The CDISC Advisory Council (CAC) is comprised of a

representative from each Corporate Sponsor company. The CAC participates in

Advisory Council meetings, working teams and task forces, supports the Strategic

Plan, participates in fund-raising, and works to enhance the organization’s public

image.

CDISC Coordinating Committees: CDISC Coordinating Committees support global

CDISC initiatives within specific regions of the world and provide regional feedback

to the central CDISC organization. CDISC 3Cs help to strengthen relationships with

international and local entities as well as organizations in their respective regions.

CDISC Technical Leadership Committee: The Technical Leadership Committee

is composed of CDISC Team Leaders. Their primary responsibility is to review

standards projects and determine the way that standards should be developed.

CDISC Teams: CDISC Teams are composed of hundreds of volunteers around the

globe who develop, use and maintain our open standards.

CDISC User Networks: CDISC User Networks enable face-to-face interactions in

specific regions or languages, depending on the region. They are self-formed groups

that encourage the adoption and understanding of the usefulness and value of

CDISC standards.

CDISC Members, Stakeholders, Supporters, Adopters and Volunteers: It would

not be possible to develop the CDISC standards without the incredible support we

have had from our members, stakeholders, supporters, adopters and volunteers.

≥ 10 > 100 > 500 > 1,000 > 10,000

CDISCAdvisoryCouncil

CDISCBoard ofDirectors

CDISCCoordinatingCommittees

TechnicalLeadershipCommittee

CDISCUser

Networks

Diagram above illustrates the relationship between and different sizes

of the varied groups that represents CDISC.

CDISCOperations

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new Austin officeWhile it might be surprising, as many of our CDISC events occur on the East Coast of

the United States and around the world, the majority of CDISC staff are actually based

out of Austin, Texas. CDISC has been a virtual organization since it was founded in

1997. However, in the interest of having a central location for meetings, conferences,

and other CDISC events, CDISC partnered with the Texas Medical Association (TMA)

to have access to office space in downtown Austin in Fall of 2012. This location

has offered a fantastic opportunity for staff, CDISC members and volunteers to

finally meet face-to-face. In addition to an office, TMA provides conference rooms,

boardrooms and meeting/educational facilities on site, and creates an excellent,

centralized location with other organizations interested in serving patients. We have

already hosted the CDISC Course, “Global Approach to Accelerating Research,” and

a meeting of experts on standards for a Learning Health System at our office. We

invite you to visit us and we look forward to hosting many future events at our new

location in Austin!

2012 Milestones

10-year Anniversary for CDISC Japan2012 marked the 10th anniversary of the Japan CDISC Coordinating Committee (J3C),

and in celebration of this milestone, CDISC honored their long-standing support at

the 2012 Japan Interchange in Tokyo. Amongst their many accomplishments, the

J3C has had an impressive track record of increasing the amount of support from

government, academia and the private sector in regard to implementation and

utilization of the CDISC standards. These partnerships truly epitomize the CDISC

motto “Strength through Collaboration.”

CDISC and the Critical Path Institute

(C-Path) announced the formal launch of

the Coalition for Accelerating Standards

and Therapies (CFAST) at the 2012

International Interchange in Baltimore,

Maryland in October 2012. CFAST is an

initiative to accelerate clinical research

Diagram above illustrates the relationship between and different sizes

of the varied groups that represents CDISC.

and medical product development

by facilitating the creation and

maintenance of data standards, tools,

and methods for conducting research

in therapeutic areas important to public

health. CFAST assists FDA and others

in meeting its PDUFA V performance

goals of “improving efficiency of human

drug review through required data

submissions standardization.”

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Teams, Global CDISC Coordinating Committees & user Groups

CDISC depends on its many volunteers to develop, adopt

and maintain the CDISC standards as well as lead the

effort to implement them in their own organizations.

Through the efforts of this worldwide network of

hundreds of volunteers, CDISC catalyzes productive

collaboration to develop industry-wide data standards

enabling the harmonization of clinical data and

streamlining research processes from protocol through

analysis and reporting. The CDISC suite of standards

has been in continuous development by a multitude of

dedicated multidisciplinary volunteers from a variety of

organizations working together in teams.

The ADaM Team Led by Nate Freimark, the Analysis

Data Model (ADaM) team specifies the fundamental

principles and standards to follow in the creation of

analysis datasets and associated metadata. In 2012, the

team successfully released:

• ADaM AE v1.0• ADaM TTE v1.0• ADaM Sample Data

• ADaM v1.2 Validation Checks

BRIDG Semantic Coordination Committee The

Biomedical Research Information Domain Group

(BRIDG) Semantic Coordination Committee (SCC)

supports the goal of semantic interoperability within

clinical research and between clinical research and

healthcare. Julie Evans leads the SCC and also ensures

CDISC semantics are represented in the BRIDG model.

In 2012, the team successfully released:

• BRIDG v3.2

The CDASH Team Led by Rhonda Facile, Katie Carothers

and Shannon Labout, the Clinical Data Acquisition

Standards Harmonization (CDASH) team developed the

initial CDASH standard, which defines basic standards

for the collection of clinical trial safety data. The team

developed the user guide for the latest version of the

CDASH standard, and is developing domains needed to

support TA standards development and new domains

(devices) and variables for SDTM. In 2012, the team

released:

• CDASH User Guide v1.0

The Medical Device Team Led by Carey Smoak and

Rhonda Facile, the CDISC Device Team’s goals are

to identify the basic collection fields (CDASH) and

submission (SDTM) variables and mappings to support

the majority of device studies and modalities. In 2012,

the team released:

• Medical Device Supplement to SDTM v1.0

The Protocol Representation Group Led by David

Gemzik, the Protocol Representation Group works

to develop and publish standard, structured protocol

representations that will enable interchange of protocol-

required data and metadata among systems, stakeholders

and operations staff throughout the lifecycle of the

study. In 2012, the team released:

• PRM Toolset v1.0

The SDS Team Led by Dan Godoy and Barrie Nelson, the

Submission Data Standards team develops standards for

the submission of tabulation data from clinical trials. In

2012, the team released:

• SDTM v1.3• SDTM Implementation Guide v3.1.3

The Controlled Terminology Team Led by Chris Tolk and

Bernice Yost, the CDISC Controlled Terminology team

supports the terminology needs of all CDISC standards

and all disease/therapeutic area standards working

closely with the National Cancer Institute’s Enterprise

Vocabulary Services group. In 2012 the team released:

• Terminology Packages 10, 11, & 12

CDISC SHARE Team Led by Rhonda Facile, Mike Ward

and Dave Iberson-Hurst, the CDISC Shared Health

and Clinical Research Electronic Library (SHARE)

team developed requirements and content for a global,

accessible electronic library, which, through advanced

technology, enables precise and standardized data

element definitions and richer metadata that can be

used in applications and studies to improve biomedical

research and its link with healthcare. In 2012, the team

released:

• CDISC SHARE RFI

This request for information was to identify

potential collaborators for its proposed SHARE

Global Metadata Repository. Stay tuned for updates

on this exciting project!

The XML Technologies Team Led by Sam Hume and

Sally Cassells, the XML Technologies team creates XML

representations of CDISC standards. They also aid in the

development of models that support the instantiation of

standards in XML, and are completely responsible for

the development of ODM. In 2012 the team posted for

comment the anticipated 2013 release:

• Define.xml v2.0 (for comment)

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The SEND Team Led by Lou Ann Kramer, the Standard

for Exchange of Nonclinical Data (SEND) team is

responsible for overall development and maintenance

of the production SEND Implementation Guide and its

alignment with SDTM. The team is currently preparing

a new version of SEND that will include Reproductive

Toxicology and Safety Pharmacology data.

The Healthcare Link and IHE Quality, Research and Public

Health Committee Led by Landen Bain, the Healthcare

Link initiatives provide methods, tools and guidance to link

healthcare information technology systems, primarily the

electronic health record (EHR), to research systems such

as EDC and CTMS. This is an effort to ease the burden of

effort at healthcare sites that conduct research studies,

and to create an electronic source solution that meets

regulatory requirements. In 2012, this group released:

• CDISC/IHE Clinical Research Document (CRD) Profile• CDISC/IHE Clinical Research Process Content (CRPC)

Profile

The CDISC Standards Review Council, which is responsible

for reviewing and approving all CDISC standards prior

to posting, includes Sally Cassells, Wayne Kubick, John

Troxell, Diane Wold and Fred Wood.

CDISC is always looking for interested individuals to

participate in standards development teams. Looking

forward to 2013, CDISC will be looking for new members

for existing teams and establish additional teams for

specific Therapeutic Area Standards. If you should be

interested in supporting CDISC as a team member for

one of our existing or upcoming standards development

projects, contact us at info@cdisc.org.

The Global CDISC Coordinating Committees were founded

in 2002 to support global CDISC initiatives within specific

regions of the world and to provide regional feedback to

the central CDISC organization. They differ from User

Groups in that they are sanctioned directly by the CDISC

Board of Directors and CDISC Executive Operations. The

primary 3C activities are defined in collaboration with

CDISC Executive Operations; these activities receive

support from CDISC Operations and require effective

communications between the two groups. CDISC 3Cs

represent the CDISC organization around the globe,

and help to strengthen relationships with international

and local entities as well as organizations in their

respective regions. The primary aim is to promote the

value of CDISC and its vision and mission. One of the

responsibilities of the 3Cs is to organize and promote

annual CDISC Interchanges or other such activities in

their regions.

CDISC User Networks enable face-to-face interactions

in specific regions or languages, depending on the

region. They are self-formed groups that encourage the

adoption and understanding of the usefulness and value

of CDISC standards. The purpose and benefits of CDISC

User Networks are to 1) share CDISC implementation

experiences periodically in a given region or language,

2) discuss draft standards and comments to CDISC, 3)

discuss mature standards and provide feedback to CDISC

on usefulness, 4) discuss new ideas to be channeled into

CDISC, 5) network among colleagues, and 6) share recent

conference participation and learning.

User networks in 2012 represented CDISC in China

(Shanghai and Beijing), Japan, Europe (French-speaking,

Therapeutic Area Standards Development

CDISC is actively collaborating with a variety

of partners, including the Critical Path Institute

(C-Path), National Cancer Institute and other NIH

Institutes, U.S. Food and Drug Administration

(FDA), TransCelerate Biopharma Inc. and many

other organizations to develop the Therapeutic

Area (TA) Data Standards.

TA standards released (and associated partners)

in 2012 were:

• Tuberculosis TA User Guide v1.0

The Bill & Melinda Gates Foundation,

Global TB Alliance, C-Path, U.S. Centers

for Disease Control, FDA, The National

Institute of Allergy and Infectious

Diseases, Tibotec (J&J), Sanofi, Otsuka,

Duke University

• Pain TA User Guide v1.0

ACTTION, University of Rochester, FDA

• Virology TA User Guide v1.0

FDA/NIH Grant

• Parkinson’s TA User Guide v1.0

NIH National Institute of Neurological

Disorders and Stroke (NINDS), C-Path,

FDA

English-speaking and German-speaking), South

Africa, and in ten areas across the United States (Bay

Area, CA; Boston; Atlantic region; San Diego; Midwest;

Delaware Valley; Raleigh-Durham; Heartland; Seattle;

Washington, DC).

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2012 Collaborations

Innovative Medicines Initiative (IMI)

In 2012, CDISC continued an extremely valuable partnership with IMI and provided a second educational session at the IMI central offices in Brussels. All

IMI consortia were encouraged to send participants. CDISC is currently a partner on three major project consortia.

The EHR4CR project (Electronic Health Records for Clinical Research http://www.ehr4cr.eu) is in its third year and CDISC is contributing to the semantic interoperability and pilot work packages. EHRCR is, to date, one of the largest public-private partnerships aiming at providing adaptable, reusable and scalable solutions (tools and services) for reusing data from Electronic Health Record systems for Clinical Research.

The BioVacSafe project (Biomarkers for Enhanced Vaccine ImmunoSafety http://www.biovacsafe.eu) kicked off March 2012 with the first annual meeting. The goal of BioVacSafe is to develop cutting edge tools to speed up and improve the testing and monitoring of vaccine safety, both before and after release to the market. CDISC is working with Charité University in Berlin on the data collection and management system to ensure conformance with CDASH, SDTM and Controlled Terminology standards.

The eTRIKS project (European Translational Information & Knowledge Management Services http://www.etriks.org) was launched in November. CDISC is leading the data standards work package with Roche and IDBS. Building upon the open source tranSMART system, eTRIKS will provide 1) a sustainable Knowledge Management Platform and Service to support Private/Public Translational Research (TR) across IMI and 2) a single access point to standardized curated TR study information. eTRIKS will bring data together from key IMI projects, many focused on Therapeutic Areas such as severe asthma, rheumatoid arthritis, depression and schizophrenia, tuberculosis, as well as breast, colon, prostate and lung cancer.

The Translational Research Informatics (TRI) Center

In 2012, TRI, which is funded by the

government of Japan, trained a CDISC expert

education instructor (the first in Asia) and

continues to encourage all of its academic

partners to use CDISC standards. Additionally, TRI

published CDISC as the Global Standards, a publication

featuring all articles discussing CDISC that had originally

been printed in the Japanese medical journal Rinsho Hyoka

(Clinical Evaluation) in 2012.

The Critical Path Institute (C-Path)

C-Path remains a strong partner with

CDISC. C-Path makes the CDISC

standards tangible by testing them

through development of valuable

research databases that are aggregated using CDISC

standards to ensure scientific integrity of the content. In

2012, CDISC and C-Path launched a new initiative called

Coalition For Accelerating Standards and Therapies

(CFAST), described under our 2012 Milestones. Through

the CFAST initiative, a new process for accelerating the

development of therapeutic area standards was created

(based upon lessons learned from previous therapeutic

area projects where CDISC and C-Path collaborated). This

is now being tested in a new area, Asthma.

TransCelerate BioPharma (TCB)

Formed in 2012, TCB is a non-profit organization formed by 10 global healthcare and pharmaceutical companies with the goal of improving

the quality of clinical studies and enabling new medicines to reach patients faster by facilitating the collaboration required to solve common challenges encountered during the clinical trial process. There are five projects, one of which is standards development and is an incentive for the CFAST partnership between CDISC and C-Path – to speed

TA standards development. TransCelerate will provide greater access to resources from the pharmaceutical industry that will contribute to standards development projects.

National Cancer Institute Enterprise Vocabulary Services (NCI EVS)

NCI EVS has been providing

CDISC with expert services

to develop and maintain its

controlled terminology since 2005. This invaluable and

essential partnership continues to expand with NCI EVS

providing critical terminology support and resources for

CFAST therapeutic area projects. Additionally, NCI EVS

provides terminology services to other key partners such as

US FDA and many NIH Institutes (e.g.

National Institute of Child Health &

Human Development). NCI is also a

key stakeholder organization for the

BRIDG model.

The Learning Health Community

CDISC was involved in the planning of

the first Learning Health System Summit

in May 2012. Sponsored by the Joseph H.

Kanter Family Foundation and working with

Dr. Charles Friedman of the University of

Michigan, the outcome of this Summit has been a set of

Core Values for a Learning Health System and a growing

Community. During the Summit, CDISC agreed to lead one

of the critical initiatives of an LHS – identifying a core set of

standards to enable learning, i.e. an important link between

healthcare and research. CDISC has endorsed the LHS Core

Values and the Essential Standards to Enable Learning

(ESTEL) initiative was christened in November 2012. Dr.

Rebecca Kush, CDISC President and CEO, also represents

Research on the U.S. Health Information Technology (HIT)

Standards Committee.

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CDISC Education in 2012

The CDISC authorized training program provides the only courses for the CDISC standards that are developed under the authority of a CDISC Operating Procedure (COP-005). This ensures that the training materials are developed under the authority of the CDISC technical teams and delivered by instructors who are CDISC staff or industry experts who have undergone a rigorous qualification process.

Developed to advance the CDISC mission and to ensure dissemination of authoritative training across the medical research continuum, CDISC authorized courses are identified by the Education logo and are only available through CDISC Education. Look for the logo to be sure that you are receiving authorized CDISC training.

Meeting the Challenges of the Future

The CDISC Education team recognizes the need to address global training needs both now and in the future. To meet those needs in a sustainable and responsible way, our teams are actively working on the deployment of our first online training courses with certification. We plan to roll out Online Training for the CDISC foundational standards in 2013. This will ensure consistency in the presentation of course materials, provide a cost-effective alternative to classroom training, and include a mechanism for assessing student comprehension of the material prior to issuing a certificate.

EDUCATION

Authorized CDISC education

Gold Members

1. Access to ‘Members Only’ area on

the CDISC website for all of the

organization

2. Access to new documentation for

CDISC standards

3. CDISC Case Studies

4. CDISC Business Case

5. Tools, presentations and team

Information

6. Access to new data standards

and useful information (e.g.

Pharmacogenomics Domains,

ADaM validation checks, FDA-

CDISC pilot reports)

7. Introduction to CDISC Course

• 20% Discount for CDISC

Training Courses and CDISC

sponsored events, e.g.

Interchanges

• Opportunity be a CDISC

Registered Solution Provider

• HL7 Member rates to HL7

Working Group Meetings

• Invaluable partnership

prospects and networking

opportunities with peers and

visionaries

• Receipt of personalized plaque

CDISC Membership Benefits

CDISC Authorized Courses:

1-day ADaM Implementation 1-day CDASH Implementation ½-day Controlled Terminology Implementation 1-day Deep Dive BRIDG Workshop ½-day Introduction to BRIDG 1-day LAB Implementation 1-day ODM Implementation ½ -day Protocol Representation 2-day SDTM Theory and Application 2-day SDTM Theory and Application for Medical Devices 1-day Healthcare Link

CDISC Courses in Development

for 2012:

SEND Define.xml Therapeutic Area-specific Courses

2012 CDISC Training Milestones

Authorized CDISC Education courses were conducted worldwide in 2012 in multiple locations across the continents of Asia, Europe, and North America. CDISC issued 1,155 certificates for all public and private education courses held. In addition, multiple attendees participated in modular training courses at FDA-CDER. CDISC currently has 27 qualified instructors delivering authorized CDISC training globally.

Platinum Members

All the benefits of Gold Level PLUS the

following:

1. Representation on the CDISC

Advisory Council (CAC), through

which the following benefits accrue:

• Opportunity to provide strategic

advice to CDISC leadership

• Teleconferences that include

implementation experiences from

peers and CDISC updates from

Operations staff

• Opportunity to be on Board

Committees (Strategy, Technical,

Financial)

• Opportunity to vote a Board

Member onto the CDISC Board of

Directors

• Opportunity to participate in Town

Hall meetings with regulators

• Networking at face-to-face

meetings

2. Access to the CAB area of the CDISC

Portals

3. Access to Team area of the CDISC

Portals

4. Additional 20% Discounts (i.e. 40%

total) for CDISC Training Courses

and CDISC sponsored events, e.g.

Interchanges

5. Opportunity for a personal onsite

delivery of the New “CDISC Global

Approach to Accelerating Medical

Research” at Members’ Request

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2012 CDISC Membership

CDISC standards and related innovations would not be possible without

the dedicated volunteer efforts and financial assistance of a great

number of members and supporters across the healthcare industry. In

2012, CDISC officially exceeded 300 members, reaching 302 members

by December 2012. Our members were located in 23 countries and

across 12 different industry categories. Information about our members

through 2012 is below.

Additions due to new memberships and attritions due to mergers and

acquisitions, companies going out of business, etc. are illustrated on a

year-by-year basis on the Membership Trend chart.

Members by Industry

CDISC Membership Trend 2000-2012

Pharmaceutical: 18%

Other: 3%

Healthcare Provider: 2%

Government: 2%

Consulting: 7%

Academic Institution: 2%

BioTech: 5%

NPO: 3%

Medical Device: 1%

Clinical Laboratory: .33%

CRO: 26%

Technology ServiceProvider: 32%

0

50

100

150

200

250

300

350

2000

200

PlatinumGold

2001

4918

2002

4644

2003

5677

2004

6678

2005

3852

2006

7470

2007

92117

2008

88152

2009

88154

2010

94187

2011

89181

2012

89213

20

67

90

133 144

90

144

209

240 242

281 270

302

Australia 2

Belgium 9

Canada 4

China 1

Denmark 7

Finland 1

France 10

Germany 21

Hungary 1

India 3

Ireland 3

Israel 2

Italy 1

Japan 22

Lithuania 1

Netherlands 1

Norway 1

South Africa 1

South Korea 1

Sweden 5

Switzerland 11

United Kingdom 17

United States 177

Members by Country

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2012 Communications

In 2012, the Communications Team had a

winning year, thanks to all of you who access

our information and materials in the various

ways we provide. We saw an unprecedented

increase in traffic, due to improvements to

the website, growing use of social media,

informative webinars, and the rising number of

standards released in 2012.

The CDISC eNewsletter is now released

consistently on a month-by-month basis.

This flagship communication tool includes

a compilation of all CDISC-related activities

during the month – press releases, blog entries,

new members, standards releases, case studies

highlighting the successes our members have

had using the standards, upcoming events, and

much more. The Communications Team sent

out 14 press releases during 2012, covering

major topics, from the formation of CFAST to

an inaugural CDISC Interchange in the Asia-

Pacific region.

Social media also took off in 2012, with the

creation of the CDISC Official Facebook page,

formation of the CDISC YouTube Channel,

skyrocketing membership on the official CDISC

LinkedIn Group (through which traffic nearly

doubled), and our expanded use of CDISC

Twitter.

Website Activity

Visitor Type Date Range Visits

Returning VisitorJan 2, 2012 - Dec 31, 2012 125433

Jan 1, 2011 - Dec 31, 2011 101583

New VisitorJan 2, 2012 - Dec 31, 2012 117916

Jan 1, 2011 - Dec 31, 2011 92571

TotalsJan 2, 2012 - Dec 31, 2012 243349

Jan 1, 2011 - Dec 31, 2011 194154

% change for returning visitors 23.48%

% change for new visitors 27.38%

LinkedIn Growth: Members Twitter Growth: Members

1500

1750

2000

2250

2500

2750

3000

3250

3500

Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov DecJan 1

Facebook Reach

1000

1050

1100

1150

1200

1250

1300

Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec

Congo, Democratic Republic, 1

Switzerland, 2

Montenegro, 2

United Kingdom, 18

Japan, 15

India, 34

United States, 78

Germany, 10

Belgium, 8

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2012 Financial Information

In 2012 CDISC total revenue was $4,150,879.

Although this was 2% under the anticipated

budget, expenses were 6% under budget,

allowing for CDISC to end the 2012 year with

a slightly positive net. This amount will go

into the CDISC reserves to ensure that CDISC

can sustain its standards development and

maintenance in the future.

Yearly Comparison The graph reflects the

comparison from the last three years of

financial actual versus budget results.

CDISC Financial History The historical picture

of CDISC’s financial outcomes since it was

incorporated in February 2000 (*2013 are

budgeted numbers).

Revenue 2012 Revenue of $4,150,879 for 2012

was 10% higher than the 2011 revenue of

$3,756,980. The two areas that had the most

impact on income were membership dues and

education. However, CDISC has continually

diversified its revenue streams over the years.

Expenses 2012 Expenses of $3,961,136 were

$269,864 (6%) below the budgeted $4,231,000.

Membership Renewals:

45.84%

Education: 25.97%

New Membership: 6.24%

US, European, and Japan Interchanges: 11.40%

Projects Income: 9.05%

Investment: 1.16%

Other Sources of Income: 0.34%

0

500000

1000000

1500000

2000000

2500000

3000000

3500000

4000000

4500000

5000000

2000 2001 2002 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013*2003

Income Expense

Technical Projects: 33.80%

Global Operations: 37.69%

Implementation Support/Education/

Interchanges: 19.80% Marketing/

Communications/Membership:

6.94%

Alliance/Global Expansion:

1.78%

Revenue 2012 Expenses 2012CDISC Financial History

Yearly Comparison

$4,1

50,8

79

$4,2

35,3

71

$3,9

61,1

36

$4,2

31,0

00

$189

,743

$000

$3,3

36,5

67

$3,5

75,0

00.

$3,2

18,4

33

$3,5

74,6

57

$118

,133

.95

$000

$3,7

56,9

80

$3,5

75,0

00

$3,0

49,6

89

$3,5

79,0

00

$632

,361

$000

2010 2011 2012

Income

Budgeted Income

Expense

Budgeted Expense

Net

Net Budgeted

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CDISC Team Captains

Rebecca Daniels Kush, Ph.D.

CDISC President and CEO

Rebecca Daniels Kush, Ph.D. is a Founder and the

current President and CEO of CDISC. Dr. Kush has over

30 years of experience in the area of clinical research.

She has worked for the U.S. National Institutes

of Health, academia, a global contract research

organization and pharmaceutical companies in the

U.S. and Japan. Dr. Kush has published numerous

articles in key journals, including New England

Journal of Medicine, Science Translational

Research. In 2012, she collaborated on publications

in the Japanese journal Rinsho Hyoka (Clinical

Evaluation) and wrote a chapter for a new Clinical

Research Informatics textbook. She was appointed

by the head of HHS/ONC to represent Research on

the Health Information Technology (HIT) Standards

Committee. She holds a B.S. in Chemistry and Biology

from the University of New Mexico and a Ph.D. in

Physiology and Pharmacology from the University of

California (UCSD) School of Medicine in La Jolla, CA.

Wayne R. KubicK Chief Technical Officer

Wayne R. Kubick, MBA, has over 25 years of

experience in clinical research and drug safety,

including executive management and strategy

development. He currently serves as the Chief

Technical Officer at CDISC. Prior to his CDISC role,

Mr. Kubick worked for Oracle Health Sciences as Sr.

Director of Product Strategy. Preceding this, he was

Senior Vice President and Chief Quality Officer of

Lincoln Technologies, Inc. where he served as the

Principal Investigator for its Cooperative Agreement

with the FDA to develop tools for receiving,

assessing and reviewing eSubmissions data. He

also managed Lincoln’s pharmaceutical industry

IT consulting business. From 1990 to 1998, Mr.

Kubick served as Chief Information Officer and Vice

President for IT at PAREXEL International, where

he created a professional Information Systems

organization and established a new business unit to

introduce innovative strategic technologies for data

CDISC leadership2012 CDISC Board of DirectorsPaula Brown Stafford Quintiles ChairSue Dubman SanofiRobert Goodwin PfizerDr. David Hardison Recombinant by DeloitteDr. Steven Hirschfeld NIHWayne Kubick CDISCDr. Rebecca Kush CDISCDr. Pierre-Yves Lastic SanofiDr. Frank Rockhold GlaxoSmithKlineLauren Shinaberry Business & Decisions Life SciencesDr. Eliot Siegel University of Maryland School of MedicineJohn Speakman NYU Langone Medical CenterDr. Kiyoteru Takenouchi CMIC

2013 CDISC Board of DirectorsPaula Brown Stafford Quintiles ChairDr. Carolyn Compton Critical Path InstituteSue Dubman SanofiMichael Glickman Computer Network ArchitectsDavid Handelsman SASDr. David Hardison Recombinant by DeloitteDr. Rebecca Kush CDISCDr. Pierre-Yves Lastic SanofiDr. Douglas Peddicord ACROStephen Pyke GlaxoSmithKlineDr. Frank Rockhold GlaxoSmithKlineDr. Eliot Siegel University of Maryland School of MedicineJohn Speakman NYU Langone Medical Center

Dr. Kiyoteru Takenouchi CMIC

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capture, data management and data analysis. Prior to

1990, he served as Manager of Information Systems

at BBN Software Products. Mr. Kubick also serves as

a Director on the Board of CDISC. He is a frequent

Speaker at industry conferences, and holds a BA

degree from the University of Illinois and an MBA in

MIS and Public Management from Boston University.

FRanK neWby

Executive Vice President, Development

Frank Newby holds degrees in both Biology and

Education from East Stroudsburg University and has

more than 32 years experience in the pharmaceutical

industry. Prior to joining CDISC he held the positions

of Vice President, Information Technology and Data

Management at SCIREX Corporation; Director,

Information Technology and Data Management at Cell

Pathways, Inc.; Director, Worldwide Clinical Systems

Development for GlaxoSmithKline; and held a number

of other positions in the areas of Clinical Information

Management for GSK, Aventis, Merck and J&J.

shiRley Williams

Executive VP, Finance and Administration

Shirley Williams was privileged to be the first CDISC

employee and has been a part of its growth and success

since its inception. She has over 25 years experience

in the clinical research industry and was instrumental

in the startup of two different organizations,

including CDISC. Her extensive experience is in

the areas of financials, metrics, reengineering and

process improvement and project coordination.

She has been responsible for CDISC’s financial and

legal viability, ensuring that CDISC has always used

its funds appropriately to establish and support the

CDISC standards. In 2008, Shirley was promoted to

Executive VP, Finance Administration for CDISC. Her

responsibilities in this area include legal, financial,

human resources, support for the CDISC Board and

its Financial Oversight and Governance Committees,

and coordination of the financial aspects of all of

CDISC projects and events. Shirley is the official

CDISC Treasurer and Clerk and provides financial

oversight for the CDISC Europe Foundation.

bRon KisleR

Vice President, Strategic Initiatives

Bron Kisler is a Co-Founder of CDISC and currently

serves as Vice President, Strategic Initiatives. Within

this role, he is responsible for identifying new growth

opportunities for CDISC, steering the organization into

new clinical and geographic markets, and managing

key strategic alliances. Bron has 25 years of technical

and business experience from both the public and

private sectors, and has worked in the pharmaceutical

industry for 18 years, developing innovative clinical

research solutions. He successfully spearheaded the

CDISC Terminology Program in 2005 and launched

CDISC’s initial Therapeutic Area projects, leading

Therapeutic Area standards to become a priority in the

US, Europe as well as with global biopharmaceutical

companies and key patient foundations. Bron served

as Chair of the Joint Initiative Council (JIC) for global

standards harmonization and on the BRIDG Board of

Directors. He is a graduate of the University of Central

Florida and holds 3 Bachelor of Science degrees in

Mathematics, Computer Science and Statistics.

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Austin-based CDISC Staff

Left to right, back to front: Rhonda Facile, Sr. Director of Standards & Development; Saad Yousef, Manager of Education and Membership Services; Ella Kamona, Ops Assistant; Jyoti Pillay, Sr. Accountant; Diana Harakeh, Manager of Communications; Sheila Leaman, Director of CDISC Global Relations; Andrea Vadakin, Manager of Public Relations; Katie Carothers, Project Manager of Standards Development; Dr. Rebecca Kush, CDISC President & CEO; Bron Kisler, VP of Strategic Initiatives

nationwide CDISC Staff

Left to right, Landen Bain, CDISC Liaison to Healthcare; Julie Evans, Sr. Director of Technical Services; Steve Kopko, CDISC Subject Matter Expert; Amy Palmer, Project Manager of Standards Development; Chris Tolk, Director of Terminology; and Bernice Yost, Manager of Standards Development

CDISC Staff

***CDISC Charter Members **Member for over 10 years *Member for over 5 years

www.cdisc.org

The CDISC Team Roster

info@cdisc.org

PLATINUM

AbbVie**Absolute Systems Clinical DataAccenture*Accovion GmbH**ACM Medical LaboratoryAcorda Therapeutics IncAlexion PharmaceuticalsAmgen***AMIA*Assero Limited*Astellas Pharma, Inc.*AstraZeneca AB**Bayer Healthcare LLC**BioClinica, Inc.*Biogen Idec, Inc.**Boehringer Ingelheim Pharmaceuticals***Booz Allen HamiltonBristol Myers Squibb***Business & Decision*ClinBAYClinical Research Support Center (CReS) KyushuCompleWare Corporation***Computer Sciences Corporation*Covance**Critical Path Institute*CTTI*Daiichi Sankyo, Inc.*Dainippon Sumitomo Pharma Co.,LtdDataTrak International***Digital Infuzion*Dr. Oestreich + Partner, GmbHd-Wise TechnologiesEisai, Inc*Eli Lilly and Company***Endo PharmaceuticalsEORTCeResearch Technology**F. Hoffmann-La Roche Ltd*Formedix USA**Forte Research Systems, Inc.*Foundation for Biomedical Research and InnovationFUJITSU LIMITEDGilead Sciences**GlaxoSmithKline***Greenway Medical Technologies, Inc.*IBM**

Innovative Medicines InitiativesIntegrated Clinical Systems, InJohnson & JohnsonMassachusetts Veterans Epidemiology*McDougall Scientific Ltd.*Medidata Solutions Worldwide*Medtronic, Inc.Merck & Co., Inc.***Merck KGaA*Millennium, The Takeda Oncology Company*Mitsubishi Tanabe Pharma Corporation*National Cancer InstituteNext Step Clinical Systems LLCNovartis Pharmaceuticals Corporation***Numoda Technologies, Inc.*Octagon Research Solutions, Inc.**Onyx PharmaceuticalsOracle CorporationOutcome Sciences, Inc.*Perceptive Informatics, Inc.***Pfizer***PharmaNet/i3*Pharsight Corporation***PHT Corporation***Pinnacle 21, Inc.*PointCross Life Sciences, Inc.*PPD***PRA International*Premier Research Group***Quintiles Transnational Corporation***Sanofi-Aventis***Santen, Inc.Sarah Cannon Research Global ServicesSAS Institute, Inc.**S-cubed ApsSGS Life Sciences Services*Shire Pharmaceuticals, Inc.TAKE SolutionsTakeda Pharmaceuticals America***TEVA Pharmaceutical Industries LtdTexas e-Health AllianceTheravance, Inc.*UCB Biosciences, Inc.*

GOLD

AC Medical Inc.Acronet Corp.aCROnordic*Actelion Pharmaceuticals Ltd*Active Biotech ABAdClinAdvanced Bio-Logic Solutions Corp.Advanced ClinicalAdware Research KftAkros Pharma IncAllergan**Applied Clinical Intelligence LLCAptiv SolutionsArisGlobal LLCArray BioPharmaAsklep, Inc.ATLANSTATAxio Research LLCBasilea Pharmaceutica International Ltd.*Baxter Healthcare Corporation*Beardsworth Consulting*Bioforum Ltd.BioMarin Pharmaceutical Inc.Biomedical Systems Co.*BioStat International, Inc.Biotrial BiometricsBrightech International LLCCAC CorporationCancer Research and BiostatisticsCapish!Cardinal SystemsCD3 Inc.Celgene CorporationCerafor LtdCerner Corporation*Children’s Hospital & Regional Medical, Coordinating Center*ClinData InternationalClinical DataFax Systems Inc.Clinicalprojects International GmbHClinipace WorldwideclinIT AGClinovo, Inc.Clinpharma Clinical Research LLCCmed Group LtdCMIC Co. Ltd.CNI Professional Services, LLCCognizant Technology Solutions, Inc.Colorado Prevention CenterComprehend SystemsCRC PharmaCROS NT s.r.l.Cross Metrics SA

CTEP Ltd.*Cubist Pharmaceuticals*Cytel, Inc.Daegu Catholic University Medical CenterDart NeuroScience, LLCDataCeutics, Inc**Destiny CorporationDF/Net Research, Inc.DIcore Group, LLCDM-STAT, Inc.DP ClinicalDuke Clinical Research Institute***DynPort Vaccine Company LLCECRON ACUNOVA GmbHEDETEK IncEliassen Group*EMB Statistical Solutions, LLCEmboma Corporatione-Novex BVBAEntimo AG*Ephicacy Consulting Group, Inc.EPS Corporatione-Trial Co., Ltd.Evado Clinical SoftwareEverest Clinical Research Services Inc.Exelixis, Inc.Fast-Track Drugs & Biologics, LLCFeinstein InstituteFerring Pharmaceuticals*Forest Laboratories*Fred Hutchinson Cancer Research CenterFrontier Science*GCP-Service International Ltd. & Co. KGGrunenthal GmbHH. Lundbeck A/S*Hands-on LLC*Harrison Clinical Research*Health Level Seven*Helsinn Healthcare SA*HERAXHIMSS*HMS Analytical Software GmbHHurley Consulting AssociatesICON Clinical Research*IDBSIDDIIllumina Interactive*INC ResearchInfinity PharmaceuticalsInnovative Analytics Inc.Instem LSS*Institut de Recherches Internationales ServierInstitut Jules Bordet, The BrEAST GroupIntegrated Nonclinical Development Solutions, IncInvivodata, Inc.*

IPL Information Processing Ltd.IPSEN InnovationsItricaItwellJazz Pharmaceuticals, Inc.JD Young Consulting IncJennerex Biotherapeutics, Inc.Judy KingK & L Consulting Services, Inc.KAI Research, Inc.*KCT Data, Inc.Kestrel ConsultantsKinship Technologies Private LimitedLambda-Plus SALarix ApSLEO Pharma A/SLFB (Laboratoire francais du Fractionement)Liaison Technologies*LINK Medical Research ASM.A.R.C.O. GmbH & Co., KG*MacroGenics, Inc.Mathiesen & Mathiesen AG fur InformatikMaxisIT, Inc.*Mayo Clinic/Foundation*MDDXMedical Front Corp.*MedNet Solutions*Medpace, Inc.Merge Healthcare IncorporatedMetronomia Clinical Research GmbHMetrum Research Group LLC*MKS IncorporatedMMS Holdings, IncNextrials, Inc.*xNovella ClinicalNovo Nordisk*Novotech Pty Ltd.NPS PharmaceuticalsnSpire HealthNth AnalyticsOCS Consulting BVOfni SystemsOmniComm SystemsOncoGenex Pharmaceuticals, Inc.Optimer Pharmaceuticals, Inc.Orion Pharma*Otsuka Pharmaceutical Development and Commercialization, Inc.*PDS Preclinical Data Systems, Inc.PEGUS Research Inc.Pharma Consulting Group ABPharmaPros Corporation*PharmaStat LLC*Pharm-Olam International Ltd.Philip Morris Products SA

Pierre Fabre BiometriePleiad DevicesProfil Institut fuer Stoffwechselforschung*Prometrika, LLCPurdue Pharma L.P.*Q2 Business IntelligenceQST Consultants, LtdQuadratek Data SolutionsQuality Data Services, Inc.*Quanticate International LtdQuartesian LLCREGISTRAT-MAPIRho, Inc.*Robertson Centre for BiostatisticsSAIC*Salix Pharmaceuticals, Inc.SAM GmbHSamvit Solutions, LLCSciAn Services Inc.ScientiaBioScope BaltijaSimbec Research LtdStatistics and Data Corporation*Syne qua non, LtdSynergySynteractHCR, Inc.Takumi Information Technology Inc.TalentMine, LLCTarget Health, Inc.*The EMMES CorporationThe Uppsala Monitoring CentreTheorem Clinical Research*Therapeutics, Inc.TIBCO Software, Inc., Spotfire DivisionTMF - Technology, Methods, and Infrastructure for Networked Medical Research*Toray Industries, IncUnited BioSource Corporation*University Hospital Medical Information Network*Uppsala Clinical Research CenterUS Army MRMC*Velos, Inc.*Veristat, Inc.*Vertex Pharmaceuticals*Winicker Norimed GmbHWorld ProgrammingWorldwide Clinical TrialsX-act Cologne Clinical Research GmbHXClinical*XML4 Pharma*Xybion CorporationYuxi Pacific GroupZifo Technologies Private Ltd.