Clinical Research & Trials

Representative Experience

• 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.