- Development of European clinical business strategy – both pre-market and post-market within the commercial environment
- Clinical trial management from start-up to close-out
- Creation and fostering of relationships with key physician and site customers
- Site recruitment and qualification
- Core clinical trial activities such as inventory management, adverse event management and regulatory filing, protocol deviation tracking and oversight, and maintenance of local regulatory filings
- Clinical safety management and filings to regulatory agencies
- Medical writing including regulatory submissions, clinical evaluation reports, systematic literature reviews, and medical journal submissions.
- Clinical quality system procedure and process development
- Electronic data capture project management prior to study start-up and in maintenance throughout the trial
- Oversight and management of European monitoring teams
- ISO and MDR compliance