Gardner Law helps 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, remunerating healthcare professionals and healthcare entities for research services, and reporting.
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- Conducting fair market value assessments research payments
- Paying HCPs and institutions for research
- Provision of grants for research
- Drafting clinical trial agreements
- Negotiating clinical trial agreements with hospital attorneys and IRBs
- Drafting informed consents
- Good Clinical Practice Guidelines compliance
- FDAAA 801 requirements (clinicaltrials.gov)
- Good Publication Practices Guidelines
- Contract Research Organization (“CRO”) support
- Answering regulatory questions relating to research