Competitive Drug Development International Ltd (CDDI)

CDDI is a specialist bio-medical consulting company based in London and Barcelona and founded in 2009 by R&D executives from top Pharma companies. We have extensive experience of clinical development and operations across a broad range of indications. We work with clients to ensure their development plans and protocols are feasible, and to improve patient accrual. Our current focus includes: - Evidence-based Feasibility for Big Pharma and Biotechs - Protocol feasibility, Paediatric Investigational Plans (PIPs), root cause analyses for failing protocols - Site selection - Patient recruitment strategies - Process reengineering/optimization for Big Pharma and Biotechs Our other capabilities include: - Project management for Biotechs - Design and execution of Phase 1 protocols - Design protocols, site selection and manage CROs for Phase 2 protocols What is Evidence-based Feasibiliy? Evidence-based Feasibility (EbF) involves collecting real — but de-identified — data from retrospective patient records from sites that could be around the globe. Our company specific process, EbF, can show the effect of each inclusion/exclusion criterion on potential patient recruitment, allowing us to simulate alternative scenarios. This enables the client, in consultation with the experts in the field, to decide the final study protocol, finding a balance between “perfect” criteria and what is scientifically sound and yet still operationally feasible. EbF contributes to establishing a protocol: - requiring no unnecessary amendments; - with recruitment projections based on facts, not perceptions; - using the optimal number of sites. The EbF process saves overall time and resource, making it possible to carry out more effective clinical trials.