Technology enabled behavior changes for diabetic patients
IDDI Presentation
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.
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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. 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
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7. Client Base
Over the last 5 years IDDI worked with 110+ clients worldwide
Currently 75 clients – 180 projects
Other
(Medical Devices,
Nutrition…)
3% Academic
Pharmaceutical
Group
24%
17%
Biotechnology
56%
+75% repeat business!
8. 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
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9. Experience by Sponsor’s Origin
(#of trials over the last 5 years)
ASIA GERMANY NORWAY/SWEDEN/ UNITED KINGDOM
1% 2% DENMARK 7%
3%
USA
CANADA
31%
9%
SWITZERLAND
11%
BELGIUM /
FRANCE
NETHERLANDS
21%
15%
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10. Experience by Phase
(#of trials over the last 5 years)
Phase IV Multiple Phase
8% 11%
Phase I
13%
Phase I/II
2%
Phase III
36%
Phase II
27%
Phase II/III
3%
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11. Experience by Therapeutic Area
(#of trials over the last 5 years)
Multiple Gastroenterology
Musculoskeletal
Endocrine/ 2% 2%
1%
Metabolic Diseases Immunology/
1% Vaccines
2%
Dermatology CNS
1% 2%
Infectious Diseases
4%
Cardio-vascular/
Cardiology
9%
Ophthalmology
Oncology
13%
63%
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13. 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 13