Product Evaluation / Due Diligence Scientific evaluation of a product Assessment of the clinical development plan Assessment of the market potential of a compound Competitor analysis Development Advice Analysis of research results Identification of requirements for milestone decisions Development Design Individual strategies and solutions for a targeted approval and launch of your product Clinical Study Design Study protocol - selection of suitable study endpoints, patient population / subgroups and study sites Analysis of study results Approval strategies, cooperation with regulatory authorities in Europe and the US Medical Writing Study protocol according to GCP / ICH guidelines Clinical trial report according to ICH guidelines Clinical Overview / Summary Investigator Meetings Planning, organisation and presentation Rehearsals Training and preparation for hearings or meetings with the regulatory authorities