Clinical Development Strategy
Clinical, Statistical and Regulatory Expert Services to Optimize your Clinical Development Strategy
Aiming to optimize 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 patient outcomes. Whether you have focal needs or search a broad set of solutions for your development program, you may count on our 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. Our expert consultants provide high-level strategic consulting services ranging from clinical trial design and protocol development to regulatory submission and FDA/EMA meeting representation.
Our skilled consultants are often members of international expert committees and they have published over 600 scientific papers (including 4 FDA quoted papers), and are invited for lectures across the globe. Their advice has been sought by more than 270 pharmaceutical companies and biotechnology companies, as well as academic and cooperative groups in Europe, the US, and Asia.
Expert Consultancy Services for your Clinical Development Strategy:
- Our biostatistical, medical and regulatory consultants are experts in their individual fields. They work in concert when setting up a clinical development program, both for designing clinical trials and for providing support to sponsors when meeting the authorities.
- They have extensive and successful experience in the interaction with FDA and EMA, as well as other regulatory agencies.
- They can also bring the market perspective into the picture, as well as health technology assessment (HTA).
Comprehensive Services to Help with Your Clinical Drug Development Strategy:
- CLINICAL DEVELOPMENT PLANS
Based on the available preclinical data and clinical results, IDDI consultants help you with the strategic decisions that are required for further clinical drug development and approval of your product.
- STUDY DESIGN
IDDI consultants have the medical expertise, biostatistical acumen, medical writing skills, and profound knowledge of the regulatory environment that are required to design and launch clinical trials that ask the right questions, regardless of the clinical trial phase. This includes developing the concept and the full protocol document, calculating the sample size for conventional, group-sequential and adaptive designs, running trial simulations, and proposing innovative solutions to optimize chances of success in the clinical trial.
- ADVANCED BIOSTATISTICS
At IDDI, we have been leaders in the validation of surrogate endpoints and of diagnostic, prognostic and predictive biomarkers. We have been involved in numerous meta-analyses of individual patient data to directly or indirectly support new drug applications.
- REGULATORY SUPPORT
Guidance for IND and NDA submissions, biomarker approvals, paediatric exclusivity and orphan drug designations are among the spectrum covered by IDDI consultants, who have extensive experience interacting with FDA and EMA, as well as other regulatory agencies.
IDDI Consultants Team:
|MARC BUYSE, ScD||TOMASZ BURZYKOWSKI, PhD||EVERARDO SAAD, MD||STEFAN MICHIELS, PhD|
|(trial design, endpoints, biomarkers)||(surrogate endpoints, adaptive and Bayesian designs)||(trial design, endpoints, clinical issues)||(trial design, biomarkers)|
|ELS COART, PhD||KOENRAAD D’HOLLANDER, MD, MSc||AGNES WESTELINCK, PharmD|
|(development and validation of biomarkers and IVDs)||(Bayesian methods, adaptive designs)||(regulatory affairs)|