Gardner Law can provide integrated medical and technical assessments and recommendations.
Gardner Law can help you with the complex legal issues presented by clinical trials and research. This includes counseling clients on clinical trial agreements, and compliance with FDA requirements relating to subject recruitment, clinical trial advertising and Notices of Availability, reporting, privacy, Good Clinical Practices, informed consent, as well as remunerating healthcare professionals and healthcare entities for research services, and reporting research per the Physician Payments Sunshine Act.
- Negotiating clinical trial agreements
- Drafting informed consents
- Trial design
- Good Clinical Practice Guidelines compliance
- FDAAA 801 requirements (clinicaltrials.gov)
- Good Publication Practices Guidelines
- Contract Research Organization (“CRO”) support