What concerns us

How formulation properties, absorption, physiology, pathophysiology interfere with systemic exposure

Which study design fits best for BE trials with highly variable drugs

How to optimise adaptive study designs in early- stage trials and in later phases

How pharmacodynamic surrogate parameters are adequately validated

How to select the best clinical endpoint for efficacy trials

How to define patient populations best to allow for both: optimum outcome and effective recruitment

How to find an adequate balance between pragmatism and quality in non-interventional studies and in studies with medical devices

How to validate scores for patient- reported outcome

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