International Drug Development Institute (IDDI)
Information
As Regulatory Statistics and Clinical Data Science experts, IDDI provides clinical data services and high-level strategic consulting for pharmaceutical, biotechnology, and medical device/diagnostic companies.
- Founded in 1991 by Marc Buyse ScD, IDDI is a global privately-held company with offices in Raleigh (NC) and Ottignies, LLN (Belgium) and counts around 150 employees..
- A Therapy-focused CRO: Oncology, Ophthalmology, CNS diseases and Orphan drugs.
- EXPERIENCE: 1400+ Phase I-IV Clinical Trials - 20 FDA/EMA Approvals - 4 FDA quoted papers - 950+ Scientific Publications - 850+ Scientific Conferences.
- EXPERTISE:
- STRATEGIC CONSUTLIING AND REGULATORY STATISTICS: Optimizing your clinical development strategy.
- Innovative clinical STUDY DESIGN including protocol development, choice of endpoints and sample size calculation for conventional, group-sequential or adaptive designs including Bayesian designs.
- Advanced BIOSTATISTICS services: statistical analysis plan, statistical analyses, meta-analysis, statistical inputs to publication and Data Monitoring Committees
- End-to-end comprehensive DATA MANAGEMENT services focusing on the accuracy of clinical data and CDISC regulatory compliance (eCRF design, set-up and validation, data import and reconciliation, medical coding, data export and pooling of databases)
- INTEGRATED TECHNOLOGY: Randomization and Trial supply management (RTSM) through MENTOR powered by Sitero, Electronic Data capture (EDC) through Rave powered by Medidata or ID-base (Marvin) powered by EvidentIQ and medical coding.
- REGULATORY Consultancy: Representation at FDA/EMA
Products and Services
Clinical Study ReportsClinical Supplies/Distribution/PackagingClinical Trial DesignClinical Trials and Clinical OperationsConsultingData and Data StandardsElectronic Data CaptureProject Management & Strategic PlanningRegulatory Affairs/Regulatory StrategyRegulatory Document Preparation
Description of Booth Activities
- Caricaturist