Clinical Evaluation Trials

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