If you are located outside the United States
and you want to conduct a clinical study in the United States, you need an agent residing
within the US to act as the sponsor for your study (see 21 CFR Part 812.18(a)).
Clinical Device Group can act as the sponsor/agent for your trial. We have been doing
medical device clinical trials since 1990 and our President worked for large and small US
sponsors for eleven years before that, so we have a solid history of sponsor requirements.
We will:
Assure regulations and good clinical practices are
enforced.
Provide accurate and current administrative records.
Evaluate investigators' experience and training.
Submit IDEs and IDE Supplements.
Wait for IRB approvals.
Assure monitoring is timely, complete, and useful.
