Health Law

Clinical Trials & Research

Companies engaging in clinical trials must comply with numerous federal and state laws, and if your company makes a misstep, it can derail development. Satisfying this vast set of legal requirements can be tricky, especially considering that numerous agencies oversee this sector of the health care and life sciences industries, including the Food and Drug Administration (FDA), the Office for Human Research Protections, and the Department of Health and Human Services.

Our Health Law attorneys provide regulatory and strategic advice to companies of all types and sizes involved with preclinical and clinical research. We also work with academic medical centers and research staff participating in sponsored clinical research or initiating their own studies. Our broad scope of services includes counseling investors in transactions involving FDA-regulated companies, such as public and private stock offerings and mergers and acquisitions.

Working with colleagues throughout the firm, including our life sciences industry attorneys and those in the Intellectual Property, Corporate & Securities, Antitrust, Tax, and Litigation practices, our Health Law attorneys provide integrated advice on successful product development, approval, launch, and marketing efforts. We also help them prepare for and progress through the Institutional Review Board and Stem Cell Research Oversight Committee review processes.

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Linda D. Bentley

Linda D. Bentley

Member

Boston

617.348.1784

Dianne J. Bourque

Dianne J. Bourque

Member

Boston

617.348.1614

Brian J. Platton

Brian J. Platton

Member

New York

212.692.6838

Representative Experience

  • Counseled a pharmaceutical company on the acquisition of tissue samples post mortem and associated clinical data to support its research program.
  • Counseled the IRB of a large, academic medical center with a research program averaging 200 active protocols annually and ranging from late-stage drug studies to xenotransplantation.
  • Advised the Institutional Animal Care and Use Committee of a large, academic medical center on a variety of preclinical studies, including studies involving a primate model.
  • Serve as general counsel to a 501(c)(3) organization engaged in research and education in peripheral vascular disease, including advice on the initial structure and ongoing management of its entire research program; drafting, reviewing, and negotiating agreements and consent forms; and assisting with audits and other inquiries.
  • Represent a 501(c)(3) organization established to help subsidize the costs of clinical trials in the area of brain cancer, including making grants to academic medical centers that, in turn, have agreements with pharmaceutical manufacturing companies.
  • Negotiated agreements for international clinical trials for one of the UK’s major contract research organizations on behalf of a US-based pharmaceutical firm.
  • Counseled a large clinical diagnostics company on the design and implementation of a tissue banking and outcomes research program, including acquisition of clinical data within regulatory confines to support an outcomes research program.
  • Advised an academic medical center applicant throughout the NIH grant application process and with ongoing compliance with federal grants regulations.
  • Assisted a private company in the establishment of a stem cell research oversight committee to support its stem cell research program, in compliance with state and federal standards.
  • Washington G-2 Reports Legal Issues in Structuring Lab Outreach Programs Karen S. Lovitch provides general guidelines about outreach testing from a legal and regulatory standpoint.
  • Health Care Law Monthly Issues and Trends in the Regulation of Genetic Testing Karen S. Lovitch and Dianne J. Bourque provide an in-depth analysis of both the state and federal laws governing genetic testing for laboratories and patients.