IDDI / Corporate Presentation eClinical and Biostatistical Services
Company History Inc. Inc. Cambridge, MA, USA Houston, TX, USA1991 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
ExpertiseConsultancy Clinical trial program strategy, protocol design, expert mission with regulatory agenciesRandomization and Drug Supply Management(e)-CRF Design and Data ManagementBiostatistical Services Biostatistical Analyses Meta-analysesBiomarkers QualificationIDMC supportMedical Writing
Web systemseClinical 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 systemsCustomer support
Global Experience (> 2002)500+ Phase I-IV trials160+ Randomization systems in 100+ countries 50,000+ patients 6,000+ sites350+ Publications400+ Scientific presentations10 Scientific seminars since 20038 Webinars since 2010 6
Client BaseOver 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 approvalsand currently working on 30+ studies to be usedin 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
IDDIs Added ValueTeam of talented professionals with extensivescientific depthDedicated staff with virtually no turnoverRobust, flexible, cost-effective EDC and IWR solutions20 years in the clinical research businessRecognized expertise in oncologyTrack record of success storiesExtensive regulatory experience with involvement in15 FDA/EMA approvalsWorldwide reputation and scientific visibilityIndependent status 13
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