Capabilities

In Brief: A Digest of Clinical Research Trials Projects

Client Results

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.