The new MDR requires small to midsize medical device companies to take over sponsor responsibilities for their clinical trials. Some companies find they cannot take over this responsibility due to their need for:
- scientific and regulatory knowledge in clinical trials
- QM system compliant with MDR and ISO14155
- manpower to keep sponsor oversight
- other tools to manage clinical trials
- experience in selecting the best investigational study sites for their clinical trials
- training in the clinical trial requirements of their people, vendors, and study sites
GCP-Service wants to make sure that this situation does not lead to market exclusion of excellent medical devices. Therefore we offer to take over sponsor responsibilities for companies for their clinical trials. With this responsibility we work hard to prove the performance, safety, and benefit of such products to make market approval possible.
With more than 16 years of clinical trial experience GCP-Service loves to take over the responsibilities many organizations feel they are unable to do. The safety and rights of patients as well as the regulatory environment no longer allows a trial and error approach anymore. Therefore our approach is to do it the right way the first time!
Contact us today!