Clinical, Statistical and Regulatory Expert Services
HIGH LEVEL CONSULTING SERVICES TO OPTIMIZE YOUR CLINICAL DEVELOPMENT STRATEGY
Aiming at optimizing your clinical development strategy, our expert consultants develop the innovative strategies and capabilities needed to launch products with the greatest potential for commercial success and improved patient outcomes.
Whether you have focal needs or search a broad set of solutions for your development program, you can count on IDDI’s experts, who work in concert to make sure the biostatistical, medical and regulatory aspects of the program, along with its market perspective, are consistent with your goals.
Comprehensive Services to Help with Your Clinical Development Strategy
IDDI’s expert consultants provide high-level strategic consulting services ranging from clinical trial design and protocol development to regulatory submission including FDA/EMA meeting representation.
CLINICAL DEVELOPMENT PLANS
Based on the available preclinical data and clinical results, IDDI help you with the strategic decisions that are required for further clinical drug development and approval of the product
IDDI offers the medical expertise, biostatistical acumen and profound knowledge of the regulatory environment that are required to design and launch clinical trials that ask the right questions regardless of the trial phase.
Validation of surrogate endpoints and of diagnostic, prognostic and predictive biomarkers
Guidance for IND and NDA submissions, biomarker approvals, pediatric exclusivity and orphan drugs designation
MEET THE CONSULTANTS TEAM
IDDI’s highly skilled consultants are members of international expert committees, have published over 850 scientific papers and are invited for lectures across the globe. Their advice have been sought by more than 350 pharmaceutical and biotechnology companies, as well as academic and cooperative groups, throughout Europe, North America and Asia Pacific.