Rely on us to assist you with the legal aspects of your research.

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 various regulatory authorities.

Get more information about reporting research under the Physician Payments Sunshine Act:

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We have experience with the following:
  • 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

Contact us to get started.

Contact us
Gardner Law

423 Main Street South
Stillwater, MN 55082
office@gardner.law
+1 651.430.7150

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April 2020: Seeking FDA Emergency Use Authorization for a COVID-19 medical device?

November 2020: Regulatory update from both sides of the pond.