1. IDDI / Corporate Presentation
eClinical and Biostatistical Services

2. Company History
Inc. Inc.
Cambridge, MA, USA Houston, TX, USA
1991 1996 2001 2004 2006 2010
2010 2011
Operations
centered in
Belgium
SARL, Paris

3. IDDI , a Clinical Data Center
The mission of IDDI is to deliver
clinical trial results that are
scientifically accurate,
validated and reproducible.
3

4. Expertise
Consultancy
Clinical trial program strategy, protocol design, expert
mission with regulatory agencies
Randomization and Drug Supply Management
(e)-CRF Design and Data Management
Biostatistical Services
Biostatistical Analyses
Meta-analyses
Biomarkers Qualification
IDMC support
Medical Writing

5. Web systems
eClinical Suite
Central Randomization (ID-net™) and Treatment Allocation
(ID-supply™)
Data Management (EDC) integrated with ID-net™
Coding of Medical Terms (ID-code™)
Secured sharing of documents and data (TrialControl™)
Validation of systems
Customer support

6. Organizational Chart
CEO
COO CONSULTANTS RESEARCH
Information & Quality
Technology Assurance
Projects & Business
Finance & HR
Contracts Development
eClinical Project Biostatistical
Services Management Services
Data Support & EDC &
Management Validation Randomization

7. Global Experience
(> 2002)
500+ Phase I-IV trials
160+ Randomization systems in
100+ countries
50,000+ patients
6,000+ sites
350+ Publications
400+ Scientific presentations
10 Scientific seminars since 2003
8 Webinars since 2010
7

8. Client Base
Over the last 5 years IDDI worked with 110+ clients worldwide
Others (Medical
Devices, Nutrition)
Biosimilar
Biotechnology 3% 5%
48%
Academic Group
4 out of the top 4
14%
Pharmaceutical
30%
5 out of the top 5
+75% repeat business!

9. FDA / EMA approvals
Involvement in
15
FDA/EMA approvals
and currently working on 30+ studies to be used
in submission dossiers in the US and/or Europe
9

10. Academic Collaborations
USA & Canada
NSABP, TRIO, C5
France
AERO, ARCAD, FFCD, GERCOR, IGR, iPRI (International Prevention Research
Institute), MAGIC
Belgium
BIG, Bordet Institute, EORTC, Hasselt University, KUL, UCL, ULB
United Kingdom
Medical Research Council (MRC)
Italy
European Institute of Oncology, Milan
Asia
Nagoya University – Japan
Indian Cooperative Oncology Network– India
Tata Memorial – India
Australia
University of New South Wales
10

11. Experience by Sponsor’s Origin
(#of trials over the last 5 years)
ASIA DENMARK /SWEDEN
SPAIN GERMANY
1% 2%
1% 3%
UNITED KINGDOM
6%
USA
CANADA
34%
8%
SWITZERLAND
12%
BELGIUM/
NETHERLANDS
13%
FRANCE
20%
11

12. Experience by Phase
(#of trials over the last 5 years)
Translational Phase I
Phase IV 6% Phase I/II
7% 13%
4%
Phase II
30%
Phase III
36%
Phase II/III
3%
12

13. Experience by Therapeutic Area
(#of trials over the last 5 years)
Genitourinary Respiratory Inflammatory Endocrine /Metabolic Immunology/
1% 1% 1% diseases Vaccines/
Musculoskeletal Allergology
1%
1% 1%
Dermatology
1% Gastroenterology
2%
Transplant
1% CNS
3%
Infectious Diseases
3%
Cardio-vascular
7%
Ophthalmology
Oncology
14%
63%
13

14. Experience by Tumor Type
(#of trials over the last 5 years)
Head and neck cancer Multiple Supportive Care Bladder Cancer Melanoma Multiple
1% 1% 1% 2% 2% 2%
Solid Tumors
Colon Cancer
2%
1%
Brain cancer
Basal cell carcinoma
2%
1%
Sarcoma, GIST
Breast Cancer 2%
30% Liver/Biliary/
Pancreas cancer
3%
Gastric cancer, Stomach
4%
Prostate Cancer
4%
Lung Cancer / NSCLC
14% Renal Cell Carcinoma
4%
Gynecological cancer
5%
Lymphoma / Multiple
Leukemia myeloma (MM) Colorectal Cancer
8% 6%
8% 14

15. Why IDDI?

16. IDDI's Added Value
Team of talented professionals with extensive
scientific depth
Dedicated staff with virtually no turnover
Robust, flexible, cost-effective EDC and IWR solutions
20 years in the clinical research business
Recognized expertise in oncology
Track record of success stories
Extensive regulatory experience with involvement in
15 FDA/EMA approvals
Worldwide reputation and scientific visibility
Independent status 16

17. Any Questions ?

18. Spare slides

19. Experience by Sponsor’s Origin
(in value over the last 5 years)
GERMANY SPAIN BELGIUM/
UNITED KINGDOM 3% 4% NETHERLANDS
2% 4%
DENMARK/
SWEDEN
6%
USA
43%
ASIA
6%
CANADA
9%
SWITZERLAND
10%
FRANCE
13%
19

20. IDDI valued by its clients
Pharmasset:
"Thank you for your hard work and diligence in getting this EDC system up in an
extremely short amount of time! I have not experienced a vendor in the past who
can go from eCRF/User Requirements approved to system live in a timeframe like
this! You deserve a huge round of applause!!“
Rose Johnstone, Clinical Data Management Director, Pharmasset, Princeton, NJ, USA
I only have good things to say about IDDI:
consistently responsive and prompt with communications
displays regular flexibility in meeting Pharmasset needs and changing study designs
exhibit professional and respectful attitude
HelpDesk support regularly provides fast resolution and response for CRO, Site and
Pharmasset staff
knowledgeable and understanding of not only EDC, IWRS platforms, but the clinical trial
process and how to best (proactively and reactively) implement design strategies
system build timelines are the fastest of any vendor I have seen
little or no go-live issues arise
Implementation of system changes (ID-net or Marvin) in live environment occur seamlessly
and without any noticeable system downtime.“
Michael Mader, Director Clinical Operations, Pharmasset, Princeton, NJ, USA 20

21. IDDI valued by its clients
Molecular Partners AG:
“IDDI has performed data management for our 2 phase I/II trials and I am
very happy of this collaboration. Everyone at IDDI was very responsive and
professional. Flexibility is a great asset of the team!“
Gaëlle Charier, Clinical Project Leader, Molecular Partners AG, Switzerland
Astrazeneca R&D:
"My interaction with your staff have been though e-mails and
teleconferences. They were prompt in calling into meetings, and responding to
e-mails. They were quite flexible to AZ/IDMC requests. They , were adept at
pointing out risks that AZ had inadvertently overlooked, and would always offer
solutions to mitigate the risks. The planning and actual meeting with the IDMC
was hitch-free. Your staff was always very professional, and I would rate them
5 on a scale of 1 - 5.“
Ugochi A Emeribe, Principal Statistician, Astrazeneca R&D, Wilmington, DE,
USA.
21

22. IDDI valued by its
clients
PanOptica:
“IDDI is always flexible and responsive. They clearly outline the project
timelines and budgets and stick to them; if issues arise they always
communicate them quickly. All employees are knowledgeable in their area of
expertise and the whole clinical trial process. They are proactive, provide
solutions, and point out the pros and cons of proposed solutions so that the
Sponsor can make an informed decision.”
Kristine Curtiss, Executive Director, Clinical
Operations, PanOptica, Bernardsville, NJ , USA
Ophthotech:
"Switching from paper CRFs to EDC not only significantly reduced the time
taken issue and respond to queries, it also allowed us to lock our database 2
weeks after the last patient visit. This would not have been possible with paper
CRFs. IDDI made process of switching from paper to electronic CRFs mid-study
easy for us and easy for our sites.“
Desiree Beutelspacher, Director, Clinical Development, Ophthotech, New York,
USA. 22