– IDDI is an expert clinical data services and high-level strategic consulting contract research organization , providing agile clinical trial services 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 Ottignies, LLN and Raleigh (NC) USA 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 – 850+ Scientific Publications – 950+ Scientific Conferences.
– EXPERTISE:
– 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) – Electronic Data Capture (EDC) – Medical Coding
– RANDOMIZATION and TRIAL SUPPLY MANAGEMENT (RTSM)
– REGULATORY Consultancy: Regulatory Statistics – Approval optimization strategy
Web: https://www.IDDI.com
Email: info@iddi.com