IDDI (International Drug Development Institute) was founded in 1991 by Marc Buyse, ScD, with the mission to optimize the clinical development of drugs, biologics, diagnostics, biomarkers and devices using a unique combination of advanced biostatistics and innovative data collection and data management technologies.
IDDI provides Biostatistical and eClinical services in Phase I to IV clinical trials, with a special focus in oncology, ophthalmology, CNS, cardiology, infectious diseases, musculo-skeletal, rare and auto-immune diseases.
Our biostatistical, medical and regulatory experts work in concert when setting up a clinical development program, both for designing clinical trials and for providing support to Sponsors when meeting the authorities. They have extensive and successful experience in the interaction with FDA and EMA as well as major regulatory agencies.
IDDI has conducted over 1400 clinical trials to-date and has been involved in 20+ FDA/EMA market approvals. IDDI has offices in North Carolina, USA in addition to its headquarters in Belgium. Core Services Include: - Drug Development Planning - Protocol Development / Clinical Trial Design (including Adaptive Designs) - Data Management - Biostatistical Analysis - Biomarker and diagnostics/IVD Validation - Statistical Validation of Gene Signatures and Protein Expression Analyses - Integrated e-Clinical suite including EDC, Medical Coding, Randomization and Drug Supply Management (RTSM).
Specific areas of activity
What do we do?
Biostatistics and eClinical services for Phase I-IV trials
Core Services Include:
Drug Development Planning
Protocol Development / Clinical Trial Design (including Adaptive Designs)
Integrated e-Clinical suite including EDC, Medical Coding, Randomization and Drug Supply Management.
Data Management (EDC - Clinical Data Conversion Services (SDTM-ADaM))
Biostatistical Analysis - Support to IDMCs
Biomarker and diagnostics/IVD Validation
Statistical Validation of Gene Signatures and Protein Expression Analyses
For what type of studies?
Phase I-IV Clinical Studies.
Who are our clients?
Biotech - Pharma - Diagnostics- Medical Device Companies- Academics.
Data Management eCRF IVRS/IWRS Late phase IV Medical Devices Medical Writing Project Management Statistics Translation