We use our knowledge of local regulatory process and network of clinical labs to setup clinical studies for a new IVD device in Asia and Africa. We support performance evaluation, user experience and regulatory clinical studies. We undertake following activities:
- Identify a suitably equipped and regulatory compliant partner Lab for the clinical studies.
- Coordinate study protocol and regulatory ethical approval processes.
- Coordinate the entire study arrangements to expedite the process.
- Monitor progress and provide regular updates on the study.
