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In Brief: A Digest of Clinical Research Trials Projects

Client Success
  • Created and implemented an administrative review process for human research studies for a large health system, including development of related policies and procedures.
  • Advised clinical trial and institutional review boards (IRBs) on compliance matters.
  • Served as legal counsel to a health system’s IRB. Attended IRB meetings; provided legal guidance; and reviewed clinical trial agreements, fee agreements, business associate agreements and nondisclosure agreements.
  • Advised pharmaceutical companies and device manufacturers on Food and Drug Administration (FDA) and state regulatory requirements.
  • Organized and supervised clinical trials for early-stage biotechnology company.
  • Prepared and negotiated biotechnology-related agreements, including clinical research agreements, noncompete agreements and confidentiality agreements.
  • Led top-to-bottom review and enhancement of medical device manufacturer’s compliance program, including clinical trials and investigation policies, procedures and implementation.
  • Drafted and negotiated clinical trial agreements with principal investigators, institutions, sponsors, SMOs and CROs.
  • Created legal entities to serve as providers, SMOs and CROs.
  • Drafted and negotiated royalty agreements between manufacturers and physicians.
  • Prepared policies and procedures for IRBs and providers administering clinical trials.
  • Created medical director and consulting agreements between sponsors and physicians.