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