The success of a clinical development and clinical trial depends partly on the biostatistical methodology which becomes more and more complex to understand. A strong statistical expertise, a deep knowledge of regulatory requirements and significant experience in clinical development are needed to conduct most of clinical studies.
Biossec has extensive experience in the following areas :
• Clinical development plans,
• Complex methodologies (Adaptive Group Sequential Design, Model-based dose finding methods, Non-Linear Mixed Effect Models, Bayesian Methods, ...),
• Resolution of issues (Multiplicity, Missing Data, Deviations, ...),
• Interaction with health authorities,
• Interim analyses and participation to iDMC and DSMB,
• Sample size re-assessment with or without unblinding.
In our experience, we have worked on more than 20 clinical development plans, interim analyses and interactions with health authorities. We propose the best powerful approach and advice the client throughout the clinical study.