Establishing links and preparing the contractual framework with regard to clinical trials
- Preparation and meeting with regulatory authorities (i.e. Pre-IDE, Q-subs, etc.)
- Preparation of clinical evidence reports
- Establishing links between our customers and clinicians involved in the studies
- Drafting of research contracts
- Drafting of patient consent forms
- Drafting of consultant contracts with experts and clinicians
- Assistance with compliance with standard requirements if ISO 14155 and other regulatory requirements