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
Organizational Chart CEO COO CONSULTANTS RESEARCH Information & Quality Technology AssuranceProjects & Business Finance & HRContracts Development eClinical Project Biostatistical Services Management Services Data Support & EDC & Management Validation Randomization
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 7
Client BaseOver 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!
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 9
Academic CollaborationsUSA & Canada NSABP, TRIO, C5France AERO, ARCAD, FFCD, GERCOR, IGR, iPRI (International Prevention Research Institute), MAGICBelgium BIG, Bordet Institute, EORTC, Hasselt University, KUL, UCL, ULBUnited Kingdom Medical Research Council (MRC)Italy European Institute of Oncology, MilanAsia Nagoya University – Japan Indian Cooperative Oncology Network– India Tata Memorial – IndiaAustralia University of New South Wales 10
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
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
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
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, GISTBreast 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
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 16
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
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
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
IDDI valued by its clientsPanOptica: “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 , USAOphthotech: "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
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