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IDDI / Corporate Presentation
  eClinical and Biostatistical Services
Company History


                            Inc.                               Inc.

                Cambridge, MA, USA                  Houston, TX, USA




1991     1996        2001          2004     2006   2010
                                                    2010   2011


                              Operations
                              centered in
                               Belgium
       SARL, Paris
IDDI , a Clinical Data Center




       The mission of IDDI is to deliver
         clinical trial results that are
            scientifically accurate,
         validated and reproducible.



                                           3
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
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
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
                                    6
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!
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

                                                  8
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%

                                                                              9
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%

                                                                                10
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%




                                                                                                     11
Why IDDI?
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

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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. 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. 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 6
  • 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 8
  • 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% 9
  • 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% 10
  • 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% 11
  • 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