Send your questions to: GCP Solutions

If you are a study site, sponsor, CRO or IRB and you have a clinical research problem, I may be able to provide some guidance via email. If you prefer, you can ask FDA directly.

Describe the problem as completely as possible. If I need more information, I will ask. I do not need to know any identifying information about your site or it's personnel. I only need your email address for response purposes.

Generally, I can provide comments quickly so there will be no charge; however, if your question is complex and requires significant time to research, I'll provide you with a research price in advance.

I will provide references to regulatory requirements with my comments.