Our device group responds to the newly revised MEDDEV 2.12.4 guidelines regarding vigilance reporting during clinical investigations, which ensures more successful and faster market access for all your products. From final clinical study reports, review and risk analyses, safety reports, and summaries of preclinical results to publications and other essential documents, Premier Research’s clinical and technical experts add bottom-line value to all of your documents.
- Vigilance Systems and Reporting
- Complaint Handling and Classifications
- Safety Reports
- DSMB Set-up and Management
- CEC Set-up and Management
For more information on our Medial Device group and service offerings, please contact us.
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