Strategic Consulting

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.

TALK TO AN EXPERT


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

STUDY DESIGN

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.

ADVANCED BIOSTATISTICS

Validation of surrogate endpoints and of diagnostic, prognostic and predictive biomarkers

REGULATORY SUPPORT

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.

Marc Buyse, ScD
Founder and Chief Scientific Officer
Everardo Saad, MD
Medical Director,Director Consulting Services
Tomasz Burzykowski, PhD
VP Research
Elisabeth Coart, PhD
Principal Biostatistician
Laurence Collette, PhD, MSc
Principal Biostatistician
Corinne Jamoul, MSc
Principal Biostatistician
Koenraad D'Hollander, MD, MSc
Principal Biostatistician
Sharavi Peeramsetti, MSc
Principal Biostatistician

Ad Hoc Consultants:

Dr. Stefan Michiels, PhD, Biostatistical Expert; Oncology and biomarkers

Dr. Agnes Westelinck, PhD, Senior Global Regulatory Expert: Development & approval of the novel therapeutic agents at FDA

Researchers:

Dr. Leandro Garcia Barrado, PhD: Research Biostatistician: Optimizing methods for development & validation of biomarker-based diagnostic tests & Bayesian outcome-adaptive designs.

Vaiva Deltuvaite-Thomas, MS: Research Biostatistician