Non-Interventional Studies (NIS) and Post Marketing Studies (PMS) are a core and important source of clinical information and an important element in the integration of clinical development.
- Study documents preparation
- Notification to competent regulatory authorities
- Contract preparation and its negotiation process
- NIS/PMS management
- Pharmacovigilance processes and accurate reporting
- Data management, scientific evaluation of data and preparation of final reports, publications and data presentation.