Clinical development plans must be consistent with regulatory strategy and competitive environment. Unmet medical needs and evolving clinical practice are key drivers for the definition of study objectives aiming to demonstrate therapeutic benefit. Clinical studies must take in account available non-clinical and clinical data that may be predictive of the benefit-risk balance of the future approved medicinal product.
- Clinical plans
Clinical plans with adequate methodological, academic and logistical support with the purpose of best documenting the medicinal product therapeutic added value.
- Trials methodology
We contribute to the robustness of trials methodology with the development of clinical study outlines/synopses and protocols with adequate selection of patient populations, endpoints selection, sample size calculation, and statistical analysis plan while ensuring that overall design is consistent with study objectives.
- Trials scientific management
We organise trials scientific management with supportive boards of experts: Executive and/or Steering Committees, Data and Safety Monitoring Committees, Endpoint Validation Committees and corresponding charters.
- Clinical operations
When needed, we assist you in the selection, contract negotiation and management of Contract Research Organisations (CROs) dedicated to Clinical Operations.
- Clinical study reports
Interpretation of study results and completion of Clinical Study Reports (CSR) in ICH format.