CDISC 2014 Annual Report
COLLABORATE
“Perfect as the wing of a bird may be, it will never enable the bird to fly if unsupported by the air.
Facts are the air of science. Without them a man of science can never rise.”
–Ivan Pavlov, Nobel Prize Winner in Physiology or Medicine, 1904
“Alone we can do so little. Together we can do so much.”
–Helen Keller
President’s Letter
CONTENTS
2 President’s Letter
3 CDISC Vision & Mission
4 CDISC Principles, Values & Strategic Goals
5 CDISC History & Standards
6 The CDISC Timeline
7 CDISC Events
8 About Our Global Organization
9 CDISC Standards in 2014
10 CDISC Collaborations
12 2014 Milestones
14 CDISC Membership and Benefits
15 Authorized CDISC Education
16 CDISC Communications
17 2014 Financial Information
18 CDISC Board of Directors, Leadership, and Staff
20 The CDISC Members
2
Dear Colleagues:
“Strength through Collaboration” has been a CDISC
tagline since 2008. CDISC progress is inextricably linked
with the many contributions of our invaluable members,
volunteers, partners, alliances and collaborators. We
have dedicated this CDISC Annual Report to you. We
wish to thank and recognize each and every one of you.
If your organization has been involved in one of CDISC’s
numerous initiatives and your name or corporate logo
has not been included anywhere in this report or located
on the back page as one of our member organizations,
please send it to us; we will include it in the electronic
version. We cannot begin to articulate our gratitude
adequately and hope that you know what a difference you
have made – not only to CDISC, but for the betterment of
patient care and global health.
The 2014 year was special for CDISC in many ways.
Although we have been working with FDA, PMDA, CFDA
and EMA for many years now (over a decade in most
cases), FDA and PMDA in particular have now announced
their intention and associated timelines for requiring
the use of CDISC data format standards in the electronic
submissions they receive for the review of applications
for new biopharmaceutical products. These regulators
also reinforced their commitment in 2014 by joining as
Platinum members. EMA and CFDA continue to work
closely with CDISC in Europe and China, respectively.
The Coalition for Accelerating Standards and Therapies
(CFAST) continued to work toward the development
of additional Therapeutic Area Standards during 2014.
CFAST is a partnership between CDISC and the Critical
Path Institute with key collaborators from FDA, NIH/
NCI, TransCelerate BioPharma, IMI, ACRO and NIH on the
development of standards for specific therapeutic areas.
Representatives from these key collaborators form the
Program Steering Committee and the Scientific Advisory
Committee. The multitude of contributors to the CFAST
initiative are highlighted in this report. The Shared Health
and Research Electronic Library was made available
during 2014, initially to CDISC Platinum members, and
we are looking forward to realizing its intended value to
make CDISC standards more accessible and accelerating
the development of additional therapeutic area
standards in 2015. We are also pleased to have our first
group of Fellows trained and contributing to CFAST and
the progress of SHARE.
We continue to envision a future where eSource (such as
electronic health records and electronic patient reported
outcomes tools) can deliver high quality research
data in CDISC standard format while streamlining
the process to make it easier for clinicians to conduct research
and patients to provide their own data for this purpose. We are
proud to have played a critical role in the development of several
standards through our partnership with Integrating the Healthcare
Enterprise (IHE) and to play a stakeholder role in the development
and support of the BRIDG model to link healthcare and research.
We are also proud to host the Learning Health Community and to
see progress toward a world where research is given a priority in
healthcare and has the opportunity to more quickly inform patient
safety and care with results based upon high quality data.
Collaboration and Communication are at the heart of what
CDISC does. With increased adoption of global standards from
the beginning of a research study, value will become increasingly
clear and research will become more efficient. We look forward
to executing the three 2015-17 Strategic Goals that the Board
Strategy developed in 2014 and are welcoming a new CDISC
Executive Director, Dr. Nicole Harmon, to ensure that we have an
integrated approach to these goals that will bring further success
to CDISC.
Once again, we wish to thank each and every one of you who
create Strength through Collaboration and contribute in your own
special way to make CDISC standards valuable globally.
Best Regards,
Dr. Rebecca Kush, CDISC President & CEO
What is CDISC?
CDISC is a global standards development organization (SDO). In the U.S. CDISC is
registered as a 501(c)(3) non-profit charitable organization. CDISC Europe Foundation
(CEF) qualifies as an EU Research Organization and the Asian entity of CDISC is CEF
Hong Kong Branch. CDISC is pleased to have over 350 member organizations across
the global research/healthcare arena. CDISC is committed to maximizing the value of
medical and research information to streamline the research process and to accelerate
the translation of research findings into clinical decisions that benefit patients around
the globe. CDISC has been made possible by the efforts and support of thousands
of dedicated volunteers, collaborating to realize the CDISC vision and mission. CDISC
global, consensus-based standards for medical research and its link with healthcare are
vendor-neutral, platform-independent and freely available via the CDISC website.
Vision
The CDISC Vision is to inform patient care and safety through higher quality
medical research.
Mission
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.
3
CDISC Principles
CDISC Values
The CDISC Core Principles are:
The CDISC values were developed in 2009 as
a way to encourage staff and volunteers to
pursue high ideals of the organization as they
are based on the principles from the Economy of
Communion (EoC), which inspires a “culture of
giving” versus a “culture of having.”
1. Lead the development of platformindependent, free and open data standards
that contribute to the faster development of
safe and effective medical products.
2. Enable the harmonization of clinical data
and the streamlining of research processes
from protocol through analysis and reporting,
including the use of electronic health records
to facilitate the collection of high quality
research data.
3. Enable regulatory submissions that allow for
flexibility in scientific content and are easily
interpreted, understood, and navigated by
regulatory reviewers.
4. Maintain multidisciplinary, cross-functional
composition for CDISC and its working groups
for the development of vendor-neutral,
consensus-based standards.
5. Catalyze global collaboration to maximize
sharing of information, minimize duplication
of effort and foster the evolution of a global
learning healthcare system.
The CDISC Core Value
Foster an understanding that the CDISC
community is an altruistic organization
contributing to the advancement of
global healthcare.
Relationships;
Friendly,
Professional
Relationships;
Respect Others
Ethics;
Mutuality –
No Separation
between Individual
and Business Principles
Business
Leadership
and Workers;
Work with
Excellence
Environment;
Harmony with the
Working Environment;
Organize Structures
Harmoniously
Communications;
Regular Company
Updates;
Encourage Input
Development;
Training and
Education;
Mentor Lavishly;
Risk in New Ideas
Quality of Life
and Productivity;
Work should be
Balanced
Strategic Goals 2015–2017
In August 2014, CDISC staff and the Board of Directors developed new strategic goals that would encourage
collaboration and foster growth for the organization.
• Promote and support the continued global adoption of harmonized data standards throughout the clinical
research lifecycle by engaging regulatory agencies, research sponsors, academia and other
stakeholders through education, advocacy and collaboration.
• Implement clinical research standards that are complementary to standards in the broader
6. Provide educational programs on CDISC
standards, models, values and benefits.
healthcare ecosystem and thus add value for clinical researchers, healthcare providers and
patients.
• Leverage the Shared Health And Research Electronic Library (SHARE) and other tools to further
expedite the development and facilitate the implementation of harmonized standards for clinical
research.
4
CDISC History & Standards
Why Do We Need Standards?
CDISC History Brief Overview
CDISC was initiated as a volunteer organization
in 1997 and was incorporated as a non-profit
organization in February 2000, initially as a 501(c)
(6). In May of 2011, CDISC attained 501(c)(3) status,
recognizing its charitable activities to provide freely
available standards worldwide to improve research
processes and thus healthcare. CDISC released its first
production models in 2000 and has had a steady record
of accomplishment ever since. Since 1997, teams of
volunteers have ensured that efficient, consensusbased global standards have been produced through
the CDISC Standards Development process. The
standards development process was updated in
2012 (using lessons learned from the development
of a number of therapeutic area standards) to an
improved, accelerated process that is now being
implemented. In 2014, Japan’s PMDA and the U.S. FDA
officially published several guidances for electronic
regulatory submissions, noting requirements for data
in CDISC standard format. CDISC standard format, and
both regulatory agencies officially joined the CDISC
membership during 2014 as well. Additionally in 2014,
CDISC issued an updated business case citing the
significant time and cost savings that can be realized
through the utilization of CDISC standards, particularly
when implemented at the beginning of the research
process.
“The importance of a standard for the exchange
of clinical trial data cannot be overstated. FDA
reviewers spend far too much valuable time simply
reorganizing large amounts of data submitted in
varying formats. Having the data presented in a
standard structure will improve FDA’s ability to
evaluate the data and help speed new discoveries to
the public.”
–Former FDA Commissioner
The word “standards” brings up many
different connotations depending on
the audience and context. In this case,
semantics are important. The CDISC
suite of data standards have been
designed to support various stages
of the clinical research process (from
Standards support traceability and
data integrity. Use of data standards
can increase the value and reusability
of data while preserving meaning as
data passes through various stages of
the research process. Standards bring
order to complexity. Below are some of
the many benefits that users of CDISC
global industry standards can expect.
protocol or study plan through data
collection, analysis and reporting)
while conforming to common research
business processes and regulatory
guidelines.
CDISC standards can streamline the
medical research process, saving time
and costs while improving quality.
•Support
•Improve and maintain consistent data quality and ensure
•Facilitate
•Improve team interactions and communications through
more streamlined research processes from
protocol through analysis and reporting
traceability across the research value chain
consistent and efficient data aggregation
to glean greater knowledge from cumulative data
assets contributed by patients for the advancement of
research
a common data language
•Support easier adoption of a variety of standards-based
tools and technologies
•Increase ability to share information among systems and
•Contribute
toward the development of a learning
healthcare system where research informs clinical care
decisions and healthcare data are used for ongoing
research
organizations
•Significantly decrease the time to initiate a new research
study
Achieving Interoperability
BRIDG
HL7 RIM
CLINICAL & NON-CLINICAL RESEARCH
Healthcare Link
HEALTHCARE
PATIENTS
Data Collection
Protocol
PRM
Study Design
Healthcare Link
ODM/
SDM
XML
¢
CDASH
CDISC-Lab
Submission/
Publication
Reporting
Tabulation
& Analyses
ODM
XML
¢
SEND
SDTM
Dataset
XML
ADaM
Define
XML
¢
SEND
SDTM
ADaM
Controlled Terminology
THERAPEUTIC AREA STANDARDS & QUESTIONNAIRES
CDISC SHARE
Foundational Standards
Data Exchange
Semantics
5
CDISC Timeline
— Organizations
350
— Teams
CDISCAccepted
intoJoint
Initiative
Council (JIC)
for Global
Harmonization
of Healthcare
Standards
— Standards & Innovations
— Globalization
— Collaboration
J3CInitiated
— Members
CDISC-IHE
Quality,
Research and
PublicHealth
Domain (QRPH)
Begins
M E M BE R S
501(c)
(3) Status
Approved
CDISC
Europe
Foundation
Launched
Labv1.0, SDTM
v3.0, SEND
v1.0, LAB v3.0
Released
E3C
Initiated
Modelingand
Nomenclature
Groups
Initiated
SDS v1.0 and
ODMv0.8
Released
CDISC
Volunteer
Group
Initiated
Therapeutic
Area
Standards
Projects
Begin
C3CInitiated
Alzheimer’s
Disease TA
Standard Package
Released
MOUSigned
with European
Innovative
Medicines
Initiative (IMI)
BRIDGModel
Initiated
Brick and
Mortar
Office
Established
in Austin,
Texas
Global
Regulatory
Authorities
Announce
Intent to
Require
CDISC
Standards in
Near Future
CDISCHong
KongBranch
Founded
CDISCBegins
Training
JapaneseSpeaking
Authorized
Education
Instructors
Launch
of CDISC
eSHARE
AP3C
Initiated
MOUSigned
with Critical
Path Institute
(C-Path), Marking
Beginningof
CFAST Initiative
30
19 97
66
YE AR S
2014
CDISC Events
THE ORGANIZATION: These are major organizational
achievements that CDISC has experienced since our inception
in 1997. Examples include the initiation of our original
volunteer group, achieving 501(c)(3) status, the launch of our
CDISC Europe Foundation.
TEAMS: Each dot in the associated color represents the
inauguration of a new CDISC standards development team.
Examples include the original modeling and nomenclature
groups, all the way to our current Foundational, SHARE and
Therapeutic Area Standards teams.
CDISC STANDARDS AND INNOVATIONS: These are new or
updated versions of the standards and innovations developed
by CDISC since our founding.
GLOBALIZATION: Globalization represents major global
accomplishments that CDISC has realized over its 18-year
history. Examples include the initiation of CDISC Coordinating
Committees (3Cs), CDISC Authorized Education courses held
for the first time around the world, CDISC Interchanges and
other CDISC events held across the globe, as well as many
others.
COLLABORATIONS: These represent significant partnerships
and relationships with organizations in the industry that have
assisted CDISC in its standards development efforts throughout
the years. Examples of different collaborations in which CDISC
is involved include our partnership with Integrating the
Healthcare Enterprise (IHE) to develop profiles to enable an
integration between clinical care and clinical research, and
our partnership with the Critical Path Institute (C-Path) to
collaborate on the development of Therapeutic Area standards
through our joint CFAST initiative, as well as a great many other
relationships with organizations in the industry.
CDISC MEMBERSHIP: This black line represents the increase in
members that have joined CDISC since our founding. As can be
gleaned from this chart, the increasing work that CDISC is able
to do would not be possible without the incredible support
of our growing membership base. To all of our members, we
thank you for your support; it is what makes this work possible.
CDISC hosts three to four global conferences
each year, with three being held in 2014. These
conferences, called “Interchanges,” are held in
Europe, Japan, the United States, and increasingly
in the Asia-Pacific region.
Record Attendance at all three 2014
Interchanges:
CDISC achieved record turnouts at all three of the
Interchanges held in 2014. Major developments,
such as the official launch of CDISC eSHARE,
global regulatory support, new therapeutic area
standards releases and projects, sessions on
CDISC standards adoption, new opportunities for
CDISC Education Courses, and updates to metrics
around adoption also helped to drive attendance
to record highs.
Growth at our three International Interchanges is
shown through the chart below:
Interchange Attendence
500
International Interchange
400
300
Europe Interchange
Japan Interchange
200
100
2012
2013
2014
Join one of our CDISC events! Find out more at
cdisc.org/event.
7
About Our Global Organization
“Never doubt that a small group of thoughtful, committed citizens can
change the world. Indeed, it is the only thing that ever has.”
–Margaret Mead
≥ 10
> 100
> 500
> 1,000
> 10,000
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 financial stability and responsibility and the strategic direction of the CDISC
organization.
CDISC Advisory Council: The CDISC Advisory Council (CAC) is comprised of a
representative from each CDISC Platinum Member organization. The CAC supports
the CDISC Strategic Goals, participates in fund-raising, and works to enhance the
organization’s public image. There are CAC representatives on 3 Board Committees
(Financial Oversight, Strategy and Technical Advisory) and the CAC Leader is an exofficio member of the CDISC Board.
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
Board of
Directors
CDISC
Coordinating
Committees
CDISC
Operations
CDISC
Advisory
Council
CDISC
Teams
Technical
Leadership
Committee
CDISC Technical Leadership Committee: The Technical Leadership Committee is
composed of CDISC Team Leaders. Their primary responsibility is to ensure that the
CDISC Teams are working toward achieving the CDISC Strategic and Operational Goals.
CDISC Teams: CDISC teams are composed of hundreds of volunteers from around the
globe who develop, use and maintain the CDISC standards.
CDISC User Networks: CDISC User Networks enable face-to-face interactions in
specific regions or languages. They are self-formed groups that encourage the adoption
and understanding of the usefulness and value of CDISC standards.
Members,
Stakeholders
Supporters,Adopters,
and Volunteers
CDISC
User
Networks
CDISC Members, Stakeholders, Supporters, Adopters and Volunteers: It would
not be possible to develop the CDISC standards and demonstrate their value without
the incredible support we have had from this increasingly large group of amazing
individuals and organizations.
For more information about CDISC bylaws, policies, charters, operating procedures and
related information, please visit the CDISC website: cdisc.org/mission-and-principles.
Diagram above illustrates the relationship between and different sizes
of the varied groups that represent CDISC.
8
2014 – CDISC Standards Progress through Collaborative Teams
Foundational Standards and Semantics
Pharmacogenomics (PGx): ImplementationGuidefor tabular
representation(SDTM) of pharmacogenomics andgenetics data.
Clinical Data Acquisition Standards Harmonization (CDASH):
Developingnewmodel anddomains tosupport theTherapeuticArea
Standards activities andCDASHv2.0.
XML Technologies: DevelopedDataset-XMLas analternativetoSASXPT
for representingtabulations (SDTMandSEND) andanalysis datasets
(ADaM) inXMLformat baseduponCDISCODM.
Submission Data Standards (SDTM): Twobatches of newdraft
content for v3.3, includingnewdomains, newmodelingapproaches and
other updates totheSDTMImplementationGuide.
Standard for the Exchange of Non-Clinical Data (SEND): Newdraft
ImplementationGuidewithupdates andadditions; newdraft Guidefor
reproductivetoxicology data.
Analysis Dataset Model (ADaM) Team: Newdraft Implementation
Guidev1.1, accommodatingadditional variables andother
enhancements; newspecificationfor results metadata using
Define-XML; newdraft OccurrenceData Structure(OCCDS).
Biomedical Research Integrated Domain Group (BRIDG) Model
approvedby ISOas a Draft International Standard. Tobepublishedas a
Final International Standardin2015.
Controlled Terminology: Quarterly updates published, addressing
morethan5,000newterms in2014.
Library (SHARE)
Therapeutic Area Standards
SHAREwas officiallylaunchedin2014. This repositorywill storeall of the
CDISCstandards inelectronicformat suchthat they will bemorereadily
accessibleandthey will facilitatere-useas appropriatetoacceleratethe
development of newtherapeuticarea standards.
Throughnumerous global collaborations (many of whichareshown
onpages 10and11of this report), volunteer contributions, andour
partnershipwiththeCritical PathInstitutethroughtheCoalitionFor
AcceleratingStandards andTherapies (CFAST) Initiative, therapeutic
area (TA) standards andother safetyandefficacy-relatedstandards have
beendevelopedtoaugment theCDISCFoundational Standards suchthat
sets of standards wereavailableat theendof 2014tosupport researchin
thefollowingareas:
By theendof 2014:
• All CDISCFoundational Standards hadbeenloadedintoSHAREtobe
availableinvarious formats (e.g. Excel, XML)
• eSHAREmadetheCDISCstandards availableelectronically toCDISC
PlatinumMembers (as aninitial group)
• Pilots wereconductedtoexplorehowbest tosupport the
development of therapeuticarea standards.
CDISC Healthcare LInk Initiative
CDISChas collaboratedwithIntegratingtheHealthcareEnterprise
(IHE) todevelopintegrationprofiles toenabletheuseof electronic
healthrecords for research. Theseprofiles (usedwithCDISCstandards,
e.g. CDASHandODM, andhealthcarestandards for EHRs), providea
standards-basedandvendor-neutral approachtoleveragingEHRs to
substantially streamlinetheresearchprocess.
In2014, theStructuredData CaptureIHEProfilewas balloted, adding to
thefollowinglist of availableCDISC-inspiredIHEprofiles:
RetrieveFormfor Data Capture(RFD)
RetrieveProcess (e.g. Protocol) for Execution(RPE)
Questionnaires, Clinical Outcomes Assessments and Functional
Tests: 30newsupplements published
Protocol Representation: Harmonizationof definitions for protocol
elements andinitial collaborationwithwithTransCelerateona Common
Protocol Template.
Clinical ResearchDocument (CRD); DrugSafety Content (DSC)
Clinical ResearchProcess Content (CRPC)
Data Element Exchange(DEX); ResearchMatching
Alzheimer’s disease
Tuberculosis
Pain
Virology
Parkinson’s disease
PolycysticKidney disease
Asthma
MultipleSclerosis
Diabetes
Cardiovascular disease
Influenza
QTStudies
Standards for thefollowingareas wereinprogress at theendof 2014:
Breast Cancer
ChronicHepatitis C
Schizophrenia
Dyslipidemia
TraumaticBrainInjury
COPD
Vaccine-preventablediseases
Ebola Virus
Malaria
Traditional ChineseMedicine
Nutritionstudies
RedactionServices
9
CDISC Collaborators
10
5/12/15, 11:14 PM
http://upload.wikimedia.org/wikipedia/commons/1/1e/University_of_Luxembourg_logo_(fr).svg
Page 1 of 1
To see a listing of all CDISC members, please see
the back cover of this report.
11
2014 Milestones
Regulatory Support during 2014:
Both the Japan Pharmaceuticals and Medical Devices
Agency (PMDA) and U.S. FDA officially released guidance
documents during 2014 that announced their plans to
require CDISC standards for eSubmissions in the near
future. These two agencies further showed their support
of the use of CDISC standards by formally becoming
CDISC Platinum members during the same year, marking
the first time that regulatory agencies joined the CDISC
membership.
management of data from patients enrolled in clinical
trials for the interventions for Ebola virus disease. The
resulting standard will be for use in EVD trials, and is
anticipated to lead to potential treatments and public
health surveillance for this disease.
“We are working with various partners and
consortia around the world to quickly evaluate
potential treatments for Ebola,” said Laura
Merson, Oxford University Clinical Research
Unit, Viet Nam. “To deliver the most rapid
and effective response to the epidemic, a wide
network of investigators has agreed to align study
outcomes and share results. When planning
this collaborative data initiative, CDISC was the
global language of choice.”
HIMSS & CDISC Sign Memorandum of
Understanding
Ebola & Malaria CRFs
CDISC and the Oxford University Centre for Tropical
Medicine and Global Health (OUCRU) officially announced
their joint collaboration
(along with a number
of others) to develop a
global standard to assist in the collection, aggregation
and analysis of Ebola virus disease (EVD) research data.
Part of this effort was the application of CDISC’s existing,
globally-accepted standards for research data (CDASH)
and virology to annotate Ebola-specific case report
forms (CRFs) and STDM to be used in the collection and
12
In November 2014, CDISC and HIMSS officially announced
through the signing of a Memorandum of Understanding
(MOU) an extension to their existing and long-standing
relationship and, in collaboration with Integrating the
Healthcare Enterprise (IHE) USA, declared their intent
to work together to foster the adoption of standards to
enable the interoperability of health IT systems.
Through this MOU, HIMSS and CDISC stated their interest
in launching additional activities focused on improving
workflow, so clinicians can conduct prospective medical
research using EHRs, and thus, fully realize the important
link between clinical research and patient care, paving
the way for a learning health system.
“I look forward to collaborating with CDISC to
apply new strategies that support the transition
to a continuously learning health system,
one in which EHR data and standards-based
information exchange supports a variety of
needs, such as safety reporting, clinical research
and improved health outcomes,” said Joyce
Sensmeier, RN, VP Informatics, HIMSS.
Updated Business Case
In September 2014, CDISC made available an extensive
update to its original business case for the use of
global, consensus-based standards for clinical research
and related areas of healthcare. One key message, reemphasized from the previous Gartner business case, is
that the use of CDISC standards at project initiation can
save 70 - 90% of time and resources spent prior to first
patient enrolled and approximately 75% of the nonpatient participation time during the Study Conduct
and Analysis stages. CDISC standards reap substantial
benefits, qualitative and quantitative, during the entire
research process for all types of research studies including
academic, nutritional, device, outcomes and regulated
research.
“In a culture of big data, increasing use of
electronic health records and complex research
designs, the importance of using CDISC data
standards for research studies has been reinforced
by those gathering metrics on such value
opportunities,” said Dr. Rebecca Kush, CDISC
President. “It is imperative that research data be
of high quality, with integrity and provenance, to
support clinical decisions on patient care.”
CDISC eSHARE Launch
In 2014, CDISC and TransCelerate BioPharma, Inc.
announced the official launch of CDISC eSHARE. For the
first time, CDISC metadata standards in multiple formats
could be electronically accessed by computer applications
through an integrated system. The CDISC Shared Health
and Research Electronic Library (SHARE), which is
comprised of both eSHARE – SHARE Exports, and iSHARE
– SHARE Interactive, is a global electronic repository for
developing, integrating and accessing CDISC standards
metadata in electronic format. eSHARE, which can
be accessed from the CDISC website, is a webpage
that provides a simple-to-use means of accessing this
machine-readable metadata, and was opened up for
access to the CDISC Platinum Membership during 2014.
“TransCelerate is happy to support the SHARE
effort by CDISC and its connection to the
Therapeutic Area Clinical Data Standards
initiative on which we partner with CFAST,”
said David Jordan, PhD, Clinical Data
Standards Leader for TransCelerate. “The
availability of published CDISC standards in a
machine-readable format is an important step
along the path to achieving the future vision of
end-to-end data flow and interoperability.”
KeyCRF
CDISC Begins CDISC Fellows Program
The goal of the keyCRF project is the creation of a
semantically annotated electronic Case Report Form
(eCRF) that can enable the pre-population of the eCRF
from linked data elements in an EHR summary document
such as HL7’s Continuity of Care Document (CCD).
The project drew upon prior work of the PhUSE-CDISC
Semantic Technology Work Group, specifically the RDF
representation of the CDISC CDASH standard. The project
uses the IHE Data Element Exchange (DEX) specification
to create the annotated eCRF, the keyCRF, by drawing on
metadata in a metadata repository (MDR) such as CDISC
SHARE or the SALUS MDR in Europe. The keyCRF can be
used to create an extraction specification that pulls
instance data from the CCD to pre-populate the eCRF.
CDISC and IHE developed a video in 2014 to explain how
this link between research data capture and the EHR is
achieved, and can be accessed through the Healthcare
Link area of the CDISC website: cdisc.org/healthcare-link.
In 2014, CDISC began the CDISC Fellows Program.
This program was created with the goal of increasing
knowledge and expertise on CDISC standards throughout
the global research community while at the same
time contributing to the efficient development and
enhancement of CDISC standards. Fellows receive training
on the process, roles and skills needed to efficiently
develop CDISC standards on a near full-time basis for a
fixed period of time (minimum of one year). The intent
of this program is to develop a new generation of CDISC
experts whose knowledge can be leveraged internally
within their sponsoring companies as well as externally
as an ongoing volunteer participant in the CDISC
community. Below is the first class of CDISC Fellows, who
began their training during the week of the 2014 CDISC
International Interchange:
CDISC Europe Foundation’s Hong Kong Branch
Opens
CDISC officially founded its first entity in the AsiaPacific region in Hong Kong in 2014. The CDISC Hong
Kong branch is associated with the CDISC European
Foundation, based out of Brussels, Belgium and led by
Paul Houston (London). Hong Kong was chosen for its
centralized location in the fastest growing market in the
world, and represents a significant opportunity for CDISC
to expand the global adoption of CDISC standards.
Pictured are CDISC Fellows: Sherwood Barbee (Quintiles), Christine
Fleeman (UCB), Gloria Jones (J&J), Ina Assfalg (BoehringerIngelheim), Tasneem Shahmalak (Theorem), Carolyn Famatiga-Fey
(Independent). Not pictured: Kathy Mellers (Independent)
13
CDISC Membership and Benefits
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 and research
industry. In 2014, CDISC officially reached more than
350 members (taking into account mergers and
acquisitions and other corporate reorganizations). This
volume exceeded the former membership high of 320
in 2013. Japan saw a 45% membership growth from
29 to 42 members this year. Our members are located
in 24 countries and across 12 different industry
categories. Refer to the figures on this page.
prior, and through these connections, CAC members
have the opportunity to help determine the future
direction of CDISC and its initiatives and to network
with other CAC members.
2014 Members by Industry
Pharmaceutical
20.1%
Non-profit 3.4%
Other 2.8%
Medical Device 0.6%
Labs 0.6%
Healthcare Provider 1.4%
Biotechnology 5.1%
CRO
30.9%
350th Member Mark Achieved
In September 2014, CDISC reached a significant milestone,
welcoming its 350th member, Hitachi Inspharma, Ltd.
CDISC sincerely thanks all of our members for their
continued support over its 18-year history.
“We are immensely grateful to our members – it
would be impossible to do the work we do without
each an every one of our member organizations
and volunteers,” stated Sheila Leaman, CDISC
Director of Global Relations.
CDISC Advisory Committee
Consulting 0.6%
4. Opportunity to become a CDISC Registered Solution
Provider; RSPs serve as subject matter experts to
organizations that want to implement CDISC Standards
5. Opportunity for member’s staff to become authorized
instructors through the CDISC Licensed Training Program
2014 Members by Country
Country
No of Members
Australia
Belgium
Canada
China
Denmark
France
Germany
India
Ireland
Israel
Italy
Japan
3
7
8
1
12
9
25
3
4
2
1
42
TOTAL: 353
Lithuania
Netherlands
Norway
Slovakia
South Africa
South Korea
Spain
Sweden
Switzerland
Thailand
United Kingdom
United States
1
1
1
1
1
3
1
5
12
1
16
193
400
350
14
2. Monthly Members Only Mini-Training Webinars that
address industry hot topics
6. Personalized Gold Member plaque
2000-2014 MembershipTrend
One of the benefits of CDISC Platinum Membership
is representation on the elite CDISC Advisory Council
(CAC). Pictured here is an exclusive Face-to-Face
Town Hall session that the CAC enjoyed prior to the
2014 International Interchange, with regulators from
around the world and the CDISC Board of Directors.
During 2014, there was more participation in meetings,
teleconferences and voting by the CAC than in any year
1. 20% discount off of CDISC education courses and CDISC
Events
3. Access to the CDISC Members Only Area to leverage a
variety of exclusive documents and tools
Technology
Service
Providers
21.8%
Academic Institutions 4.5%
Government 2.5%
Gold Member Benefits
300
Platinum Members
Gold Members
250
Platinum Member Benefits
Platinum Members receive all benefits of Gold Membership
PLUS the following:
1. Access to SHARE (Shared Health And Research Electronic)
Library
2. 40% discount off of CDISC education courses and CDISC
events
3. Representation on the CDISC Advisory Council (CAC)
with opportunities to:
• Serve on Board Committees (Strategy, Technical and
Financial)
• Vote a Board Member onto the CDISC Board of
Directors
• Participate in Town Hall meetings with regulators and
CDISC Board Members
• Network with peers, clients and visionaries at CAC
Face-to-Face meetings
200
150
4. Overview course, “CDISC Global Approach to
Accelerating Medical Research” given at Member’s site,
upon request, at no charge
100
50
0
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Learn CDISC from CDISC!
Authorative. Global. Vendor Neutral.
Authorized CDISC Education
of both the CDISC Education Summit and CDISC
Symposium, both held in Tokyo, Japan. An additional
Education summit was also held in Seoul, South Korea.
Meeting the Challenges of the Future
The CDISC authorized education 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 course
materials are developed with the cooperation of the
CDISC technical teams and delivered by instructors
who are selected and trained through a standard set
of qualification criteria.
Developed to advance the CDISC mission and to ensure
distribution of authoritative educational courses 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
EDUCATION
are receiving authorized
CDISC education.
2014 was another big year for CDISC Education, with
the launch of online versions of the SDTM, CDASH,
BRIDG and Therapeutic Area Standards User Guide
courses, as well as the first year that CDISC began
offering popular, Members-Only webinars. Major
developments were made in Japan in 2014, with
the training of our first Japanese-speaking CDISC
Authorized Education instructors, and the hosting
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 deploying
online training courses that can be accessed from
virtually anywhere in the world, 24/7, and we are
qualifying and training new instructors in Japan and
China.
2014 CDISC Training Metrics
3
14
1882
1,036
27
1,427
37
Continents with Training
CDISC Authorized Classroom Courses
ADaM Implementation
1–day
CDASH Implementation
1–day
Controlled Terminology Implementation
½–day
Deep Dive BRIDG Workshop
1–day
Introduction to BRIDG
½–day
LAB Implementation
1–day
ODM Implementation
1–day
Protocol Representation
½–day
SDTM Theory and Application
2–day
SDTM Theory and Application for
Medical Devices
2–day
Healthcare Link
1–day
SEND Implementation
2–day
Define-xml
½–day
DataSet-XML
½–day ½–day
CDISC Online Courses available in 2014
Authorized Courses
Introduction to the CDISC Website
“Seat Days”
Online Course Users
BRIDG V3.2 (9 modules)
SDTMIG V3.1.3 (18 modules)
CDASH V1.1 (8 modules)
Introduction to ADaM
Overview of Therapeutic Area User Guides
Authorized Instructors
The Future of eClinical With CDISC (Japanese)
Online Courses in Development for 2015
Classroom Course Certificates Issued
Online Course Modules
SDTM and CDASH online courses will be updated in 2015 to
the current versions and the online version of the ADaM course
will be completed. Additionally, Controlled Terminology, Clinical
Outcome Assessments, Pharmacokinetics, Pharmacogenomics,
and several other courses to cover the Therapeutic Areas will
be developed.
15
CDISC Communications
Outreach and Impact
During 2014, the CDISC Communications team expanded CDISC’s outreach and impact
in the following areas:
• Key transition to a new website platform, or content management system (CMS),
which enables greater flexibility and access opportunities;
• An updated CDISC Business Case bringing additional valuable metrics around the
time and cost savings found when using CDISC standards from the beginning of a
research study;
• A new CDISC brochure in English and Japanese, with plans for Chinese and Korean
versions in the near future;
• 14 press releases and an enhanced eNewsletter format and delivery system;
• Development of a Japanese language area of the CDISC website;
• Support for CDISC Coordinating Committees (3Cs) in Europe, Japan and China;
• Registration of trademarks for CDISC (in addition to the CDISC Logo)
• Continued website and social media management and electronic mailing
In 2015, keep an eye out for new communications that will reach out to our patient and
clinician audiences, an enhanced website look and feel, and a new mobile and tabletfriendly website interface!
The CDISC Website
The CDISC website had 312,371 total visits in 2014,
with 54.1% returning visitors and 45.9% new visitors
for the year. The website saw increases in readership
from English, Japanese, German, Chinese and Koreanspeaking countries.
45.1%
New Visitors
54.1%
Returning
Visitors
Social Media
2,037
2014 Twitter Followers by Month: 1,639 to 2,037
2014 Facebook Likes by Month: 282 to 486
6,702
2008-2014 LinkedIn Members by Year: 1 to 6,702
announcements. Many thanks to all of you who follow us on LinkedIn, Twitter and
Facebook!
486
2014 eNewsletter Readership
There were major upgrades to the CDISC eNewsletter
in 2014, with the development of a new eNews
archive on the CDISC website and enhanced access
through a new publishing and delivery system. The
total number of recurring visits to our eNewsletter
through our electronic mailing announcements was
129,358 in 2014, compared to 115,299 in 2013, an
increase of 6.9%.
16
1,639
282
1
Most Popular Tweet of 2014
“ #FDA Publishes Standardized Study Data for Electronic Submissions Guidance & Study
Data Technical Conformance Guide. ”
2014 Financial Information
In 2014, CDISC continued to demonstrate financial health. The total income for CDISC was 101%
of the annual budget, with total expenses at 90% of what had been budgeted for the year. The
surplus amount at the end of 2014 will be used to advance current standards development
projects and initiatives into Y2015 and beyond. CDISC is endlessly grateful to its members and
supporters for making this work possible.
2014 Revenue
Education
$1,646,931 29%
External Projects
$596,878 11%
Events
$664,585 12%
Financial History 2000-2014
Other
$80,273 1%
6,000,000
INCOME
Membership
Renewals
$2,227,807 39%
EXPENSE
5,000,000
New Membership
$435,010 8%
4,000,000
2014 Expenses
3,000,000
2,000,000
Events
$507,799 10%
1,000,000
0
Education
$846,733 16%
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
Information
Techology
$90,919 2%
Operations/
Finance
$586,253 11%
Technical,
Technical Projects
$984,194 19%
SHARE
$909,842 18%
Comms/Membership/
Alliances/E3Cs/
HealthcareLink
$1,216,133 24%
17
CDISC Leadership
2014 CDISC
Board of Directors
2015 CDISC Board of Directors
Dr. Pierre-Yves Lastic, Chair
Sanofi
Dr. David Hardison, Chair-elect
ConvergeHEALTH by Deloitte
Paula Brown Stafford, Past Chair
Quintiles
Dr. Charles Cooper
Becton Dickinson Diagnostics
Michael Glickman
Computer Network Architects
Pierre-Yves Lastic, PhD
Chair
Sanofi
Charles Cooper, MD
Dipak Kalra, MBBS
Joyce Sensmeier, MS, RN
Becton Dickinson Diagnostics
University College London
HIMSS
Sue Dubman, MA**
Douglas Peddicord, PhD
John Speakman, MBA
University of California,
San Francisco
ACRO
NYU Langone Medical Center
Stephen Pyke, MSc
Kiyoteru Takenouchi, PhD
David Handelsman**
SAS
Dr. Dipak Kalra
University College London
Wayne Kubick*
CDISC
Dr. Rebecca Kush
CDISC
Dr. Douglas Peddicord
ACRO
Paula Brown Stafford, MPH
Past-Chair
Quintiles
Stephen Pyke
GlaxoSmithKline
Joyce Sensmeier
HIMSS
John Speakman
NYU Langone Medical Center
Dr. Kiyoteru Takenouchi
Medical Front Corporation
Névine Zariffa
AstraZeneca
*Ex-officio
18
**CAC Leader, Ex-officio
David Hardison, PhD
Chair-Elect
ConvergeHEALTH by Deloitte
Michael Glickman, MSE
Computer Network Architects
GlaxoSmithKline
Medical Front Corporation
CDISC Staff
CDISC Operations Leadership
Landen Bain, Liaison to Healthcare
Julie Chason, SHARE Metadata Curator
Anthony Chow, SHARE Metadata Curator
Joe Ben Clark, Software Application Support Specialist
Rene Dahlheimer, Metadata Developer
Robert Dempsey, Terminology Specialist
Julie Evans, Sr. Director, Technical Services
Névine Zariffa, M. Math
Rebecca Kush, PhD
Wayne Kubick, MBA
AstraZeneca
CDISC President and CEO
Chief Technical Officer
John Ezzell, Manager of Education Products
Diana Harakeh, Director, International Development
Paul Houston, Head of European Projects, CDISC Europe
Foundation
Kit Howard, Director, Education
Steve Kopko, CDISC Subject Matter Expert
Sheila Leaman, Director, Global CDISC Relations
Amy Palmer, Sr. Project Manager, Standards Development
Jyoti Pillay, Sr. Accountant
Jonathan Zung, PhD
Bron Kisler
UCB/TransCelerate
BioPharma, Inc.
Vice President of
Strategic Alliances
Nicole Harmon, PhD
Executive Director
Sam Hume, MS
Vice President of SHARE
Technology and Services
Sara Shafer, Communications and Events Specialist
Alana St. Clair, Associate Project Manager
Andrea Vadakin, Director, Communications and
Public Relations
Ann White, Manager, Member Relations
Members of the Board
Shirley Williams, VP of Finance and Administration
from CDISC:
Diane Wold, Sr. Director, Standards Development and
Modeling
Rebecca Kush, PhD
Kaci Wood, Administrative Specialist
CDISC President and CEO
Wayne Kubick, MBA
Chief Technical Officer
Rhonda Facile, MS, MBA
Shannon Labout, CCDM
Vice President of Standards
Development
Vice President of Education
Bernice Yost, Manager, Standards Development
Saad Yousef, Manager, Education Services
19
19
The CDISC Members
PLATINUM
AbbVie**
AbsoluteSystems Clinical Data
Accenture*
AccovionGmbH**
Acorda Therapeutics Inc
AlexionPharmaceuticals
AmericanMedical Informatics Association(AMIA)*
Amgen***
Asahi Kasei Pharma Corporation
AsseroLimited**
Astellas Pharma, Inc. *
AstraZeneca AB**
Bayer Pharma AG**
BioClinica, Inc. **
BiogenIdec, Inc. **
Boehringer IngelheimPharmaceuticals ***
Booz AllenHamilton
Bristol Myers Squibb***
Business & Decision*
Capital Medica Co., Ltd.
Certara ***
Clinical Ink
Clinical ResearchSupport Center (CReS) Kyushu
CompleWareCorporation***
Computer Sciences Corporation*
Covance**
Critical PathInstitute*
CTTI *
d-WiseTechnologies *
DaeguCatholicUniversity Medical Center
Daiichi Sankyo, Inc. *
DATATRAKInternational, Inc. ***
Digital Infuzion**
Dr. Oestreich+ Partner, GmbH*
Eisai, Inc*
Ekagra SoftwareTechnologies
Eli Lilly andCompany ***
EORTC
F. Hoffmann-La RocheLtd**
Food& DrugAdministration
Formedix USA**
ForteResearchSystems, Inc. *
Foundationfor Biomedical Researchand
Innovation*
FujitsuLtd.
GileadSciences **
GlaxoSmithKline***
HCLAmerica, Inc.
IBM**
ICONClinical Research**
*** CDISCCharter Members
INCResearch
IncyteCorporation
InnovativeMedicines Initiatives
IntegratedClinical Systems, Inc.
inVentivHealthClinical *
Johnson& Johnson***
LungR&DClinical
Massachusetts Veterans Epidemiology Research
andInformationCenter **
McDougall ScientificLtd. *
Medidata Solutions Worldwide**
Medtronic, Inc.
Merck & Co., Inc. ***
Merck KGaA*
Mitsubishi TanabePharma Corporation**
National Cancer Institute
Next StepClinical Systems LLC
Novartis Pharmaceuticals Corporation***
NovoNordisk **
OnoPharmaceutical Co., Ltd.
OracleCorporation*
PAREXEL***
Pfizer, Inc. ***
Pharmaceuticals & Medical Devices Agency
Pinnacle21LLC. *
PointCross LifeSciences, Inc. *
PPD***
PRAHealthSciences *
Premier ResearchGroup***
Quality Data Services, Inc. *
QuantumLeap
Quintiles Transnational Corporation***
S-cubedAps *
Sanofi-Aventis ***
Santen, Inc.
SASInstitute, Inc. *
SCRI Development Innovations
SGSLifeSciences Services *
Shionogi & Co., Ltd
ShirePharmaceuticals, Inc. *
SOASoftware
SumitomoDainipponPharma Co.,Ltd*
TAKESolutions
Takeda Development Center Americas, Inc. ***
Takumi InformationTechnology Inc. *
Tamr
Teva Pharmaceutical Industries Ltd**
Texas e-HealthAlliance
Theravance, Inc. *
Trifecta Clinical
UCBBiosciences, Inc. **
XClinical **
** Member for over 10years
* Member for over 5years
[email protected]
cdisc.org
20
“Knowing is not enough; we must apply. Willing is not enough; we must do.”
–Johann Wolfgang von Goethe
GOLD
AACMedical Inc.
A2HealthcareCorporation*
ACMedical Inc.
ACI Clinical *
aCROnordic*
ActelionPharmaceuticals Ltd*
ActiveBiotechAB
Acucela, Inc.
AdClin
AdvanceResearchAssociates, Inc.
AdvancedClinical *
AiCure
AjinomotoPharmaceuticals Co., Ltd.
Akros Pharma Inc
AlgorithmePharma
All-RoundLifeInnovation
Allergan**
Almirall, S.A.
AMAGPharmaceuticals
Amphastar Pharmaceuticals Inc
ArisGlobal LLC
ASKLEPInc.
Associationof Clinical Research
ATLANSTAT
AxioResearchLLC*
Basilea Pharmaceutica International Ltd. *
Baxter HealthcareCorporation*
Bell Medical Solutions, Inc.
BioforumLtd.
BioMarinPharmaceutical Inc. *
Biomedical Systems Co. **
BioskinGmbH
BioStat International, Inc. *
BioStata ApS
Biotrial Biometrics
Bogier Clinical & ITSolutions, Inc.
BrightechInternational LLC
CACEXiCARECorporation*
Cancer ResearchandBiostatistics
CapishNordicAB
CD3Inc.
CelgeneCorporation*
Center of Excellencefor Biomedical andPublic
HealthInformatics
Chiltern
CHUSainte-Justine
Clindata Insight Inc.
ClinData International
Clindox Ltd.
Clinical DataFax Systems Inc.
ClinipaceWorldwide
Clinovo, Inc.
Clinpharma Clinical ResearchLLC
CMICCo. Ltd. *
CNI Professional Services, LLC
CognitiveResearchCorporation
Cognizant Technology Solutions, Inc. *
ComprehendSystems
CPCClinical Research
CPRD-Clinical PracticeResearchDatalink
CRCPharma
CROMSOURCE
CROSNTs.r.l.
Cross Metrics SA
CRSClinical ResearchServices MannheimGmbH
CRScubeInc.
CSLBehring
CTEPLtd. *
Cubist Pharmaceuticals *
Cytel, Inc. *
Dacima SoftwareInc
Dart NeuroScience, LLC
DatabeanLLC
DataCeutics, Inc **
Datalytics Pty Ltd
DeloitteConsulting, LLC
DensukeSystems Co. Ltd.
Destiny Corporation*
DF/Net Research, Inc.
DIcoreGroup, LLC
DM-STAT, Inc.
DOTInternational Co., Ltd.
DPClinical
DSG, Inc.
DukeClinical ResearchInstitute***
DynPort VaccineCompany LLC
e-Trial Co., Ltd.
eClinical Solutions, LLC
EcronAcunova GmbH
EDETEKInc
EliassenGroup*
EMBStatistical Solutions, LLC
EntimoAG
Ephicacy ConsultingGroup, Inc.
EPSCorporation
ERSquared, Inc.
EuropeanMedicines Agency
EvadoClinical Software
Everest Clinical ResearchServices Inc. *
Exelixis, Inc.
Fast-Track Drugs & Biologics, LLC
FeinsteinInstitute
FerringPharmaceuticals
Forest Laboratories **
FORUMPharmaceuticals
Foundry Health
FredHutchinsonCancer ResearchCenter
Frontier Science*
GCESolutions
GCP-ServiceInternational Ltd. & Co. KG
GenmabA/S
Grunenthal GmbH*
H. Lundbeck A/S**
H2OClinical, LLC
Hands-onGmbH*
HealthLevel Seven**
HelsinnHealthcareSA*
HERAX
HIMSS**
Hitachi Inspharma Ltd
Hurley ConsultingAssociates
IcahnSchool of Medicineat Mount Sinai
ICRC-Weyer GmbH
IDDI *
Illumina Interactive**
InClin, Inc,
Infinity Pharmaceuticals
InstemLSS*
Institut deRecherches Internationales Servier
Institut Jules Bordet, TheBrEASTGroup
Intelent
iOMEDICOAG
Ipsen*
Isis Pharmaceuticals, Inc.
Jazz Pharmaceuticals, Inc.
K& LConsultingServices, Inc.
KAI Research, Inc. *
Kaiser Permanente
Kestrel Consultants *
KinshipTechnologies PrivateLimited
KOEHLEReClinical GmbH*
KyotoUniversity Hospital
Kyowa HakkoKirinCo., Ltd.
KyushuUniversity Hospital
Lambda-Plus SA
Larix ApS
LEOPharma A/S
LFB(Laboratoirefrancais duFractionement)
LiaisonTechnologies *
Lincoln
LINKMedical ResearchAS
M.A.R.C.O. GmbH& Co., KG*
MacroGenics, Inc.
MaruhoCo., Ltd.
MaxisIT, Inc. *
MayoClinic/Foundation*
Medical ExcellenceInc.
Medical Front Corp.
MedNet Solutions *
Medpace, Inc. *
Metronomia Clinical ResearchGmbH*
MKSIncorporated
MMSHoldings, Inc*
Nagoya Medical Center
National Cancer Center
NestleClinical Development Unit
Nextrials, Inc. *
NordicBioscienceA/S
NovotechPty Ltd. *
NPSPharmaceuticals *
nSpireHealth
NthAnalytics
Nuventra, Inc.
OCSConsulting
Omeros Corporation
OmniCommSystems *
OncoGenex Pharmaceuticals, Inc.
Optimer Pharmaceuticals, Inc.
Otsuka Pharmaceutical Development and
Commercialization, Inc.
PDSPreclinical Data Systems, Inc.
PEGUSResearchInc.
PerkinElmer
Pharma ConsultingGroupAB*
Pharma Medica ResearchInc.
PharmaStat LLC*
PHASTAR
PhilipMorris Products SA
PierreFabreBiometrie
Pivotal
Profil Institut fuer Stoffwechselforschung*
Progenics Pharmaceuticals
Prometrika, LLC
PurduePharma L.P. *
Q2Business Intelligence*
QSTConsultations, Ltd*
Quadratek Data Solutions *
QuanticateInternational Ltd
QuartesianLLC
Quartz Bio
R-Square, Inc.
REGISTRAT-MAPI
Rho, Inc. *
RobertsonCentrefor Biostatistics
RPMAlliance
Salix Pharmaceuticals, Inc.
SAMGmbH
Samvit Solutions, LLC
SanaClis s.r.o.
SciAnServices Inc.
ScopeInternational AG*
SCSKCorporation
SeattleChildren’s *
Signifikans Aps
SimbecResearchLtd*
StatGroupApS
Statistics andData Corporation*
SucampoAG
Synequa non, Ltd
SyneedMedidata
SynteractHCR, Inc. *
Systex, Inc
TaishoPharmaceutical Co., Ltd.
TalentMine, LLC
Target Health, Inc. *
TheEMMESCorporation
TheGriesser Group
TheUppsala MonitoringCentre
TheoremClinical Research**
Therapeutics, Inc.
ThresholdPharmaceuticals
TIBCOSoftware, Inc., SpotfireDivision*
TMF- Technology, Methods, andInfrastructurefor
NetworkedMedical Research**
TohokuUniversity Hospital
Toray Industries, Inc
Toyama Chemical Co., Ltd.
TriumAnalysis OnlineGmbH
Ultragenyx Pharmaceutical
UnitedBioSourceCorporation*
University Hospital Medical InformationNetwork *
University of California, SanDiego
University of Iowa
University of Michigan
University of Tsukuba
Uppsala Clinical ResearchCenter
USArmy MRMC *
USCenter for DiseaseControl andPrevention
Veristat, Inc. *
Vertex Pharmaceuticals *
Winicker NorimedGmbH
WorldProgramming
WorldwideClinical Trials
X-act CologneClinical ResearchGmbH
XML4Pharma *
XOMA
XybionCorporation
ZifoTechnologies PrivateLtd.