Medical Advice and Regulatory Support
ACM’s medical team is part of a professional network of KOLs and primary investigational sites in Germany in the fields of cardiovascular, regenerative therapies, orphan drug and medical device research. Its experts have quantifiable and proven abilities to sense unrealized clinical potential in order to assist in the development and market approval of your innovative clinical research projects.
Our services include:
- Potential analysis
- Biometry and statistical analysis
- Support for and realization of funding applications
- Medical and regulatory project management
- Clinical program conception and design strategically aimed at regulatory approval and market access post approval
- Scientific integrity and operational feasibility analysis of protocol designs for regulatory approval
- Regulatory guidance and advice with the European Medicines Agency, the BfArM (German regulatory body for pharmaceuticals), the Paul-Ehrlich-Institut (German regulatory body for biomedical and vaccine products) and the DIMDI (German regulatory body for medical devices)
- Access to a network of KOLs in the German academic research community conducting cutting edge cardiovascular, regenerative therapies, orphan drug and medical device research
- Medical interface between the sponsor and the investigational sites with the goal of developing and maintaining peer-to peer level relationships
- Medical supervision during set-up and conduct and conclusion of trials
- Training programs, seminars, lectures and professional education
- Value added dossiers
- Classical medical writing
- Expert consultation on publication strategies
