We Know Medical Devices

Pleiad Devices’ experience is grounded in commercial clinical research. Unlike most contract research organizations who run device trials as a sideline, we specialize in conducting trials for regulatory, marketing and reimbursement purposes for the medical device sector.

Pleiad Devices provides the following clinical research support services for medical device companies:

1. clinical evaluations and literature reviews
2. study design
3. study protocol/clinical investigational plan preparation
4. clinician/surgeon identification
5. site selection
6. management of IRB/Ethics Committee submissions
7. clinical research regulatory submissions
8. regulatory documentation preparation including investigators brochures and instructions for use
9. investigator meetings, DSMBs and advisory boards
10. clinical project management
11. site initiation
12. vigilance and safety monitoring
13. monitoring
14. data management
15. statistical analysis
16. report writing
17. manuscript preparation

We work in compliance with all applicable clinical research quality standards and use our own or our clients’ SOPs.

Clients may select individual or multiple services or full clinical research support. The services are delivered in the USA and Europe by locally-based Pleiad staff.