Clinical Research

Guiding Companies Through Regulatory Processes

Doctors, hospitals and other health care companies that conduct clinical research and trials must comply with an expansive body of laws and regulations at both the federal and state levels.  These legal requirements are increasingly complex and failure to ensure current compliance can put a halt to crucial research activities and jeopardize the future development of the company.

The attorneys in HMBR’s Health Care and Life Sciences Practice offer strategic and regulatory advice to a variety of organizations that have clinical research as part of their business model, including academic medical centers and multi-specialty physician groups, as well as start-up companies in the biospecimen field.  Our lawyers work with clients to identify human subject research activities that require Institutional Review Board (IRB) approval and assist them in navigating that process.   Our firm also has established strong relationships with some of the nation’s foremost experts on IRBs and clinical research, providing our clients with direct access to the specialized expertise and knowledge they often need to move their clinical research projects forward.

HMBR has experience in providing general counsel to Institutional Review Boards on a variety of topics such as committee composition and conflict of interest, sufficiency of Subject Information Sheets and research protocols, including informed consent issues, and adverse event reporting.  We also have experience in reviewing and negotiating research contracts and grants with government sponsors, collaborative groups, commercial sponsors, and philanthropic organizations.

Beyond IRB approvals, the attorneys in our practice regularly advise clients on a full range of contractual issues associated with clinical study and clinical trial agreements.  We are also frequently called upon to speak on the various legal issues associated with clinical research and trials at industry meetings and conferences across the United States.