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.
- Establish a data safety monitoring board.
- Submit annual and final reports.
- Assure ongoing sponsor responsibilities are met.
- Professionally manage the overall study.
 
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