Enabling Breakthroughs

Clinical Research

Breakthroughs in scientific research and development are driving a new era in the fight against cancer. For clients looking to conduct, support or sponsor research, there is no better partner than Ropes & Gray.

Our team of leading health care and life sciences attorneys has a deep and nuanced understanding of the global research enterprise as it relates to cancer diagnostics and therapies. That knowledge—developed over years of working with academic institutions, industry players and investors in this area—allows us help clients navigate a complicated legal, regulatory and compliance landscape while continuing to advance lifesaving research. 

We counsel universities, hospitals and medical centers, pharmaceutical and medical device companies, biotechnology firms, information technology companies, and contract research organizations, as well as investors in these enterprises, on the full range of matters related to developing and commercializing cancer diagnostics and therapies. Among other areas, we advise on:

  • Conduct of research, including human subjects protection
  • Funding for research, including federal grants and contracts and reimbursement for health care issues in clinical trials
  • Clinical trial design and execution, including issues around data privacy and cross-border data transfer
  • International research collaborations, including data privacy and data/biospecimen export issues
  • Conflict-of-interest issues relating to investigator and/or institutional interests in start-up biotech companies
  • Manufacturing and supply agreements
  • IP licensing and collaborations, on behalf of both industry and academic institution clients
  • Research misconduct, including possible falsification or fabrication of scientific and clinical data

We also collaborate with colleagues from other leading practices across the firm to provide due diligence related to investments in private entities engaged in or supporting clinical and preclinical research, and help clients respond to government and civil investigations involving clinical research.

Our Work with Clients

GRAIL Develops Test to Detect More Than 50 Cancer Types

GRAIL, a Ropes & Gray client since 2017, is on a mission to detect cancer early. GRAIL’s Galleri test is a first-of-its-kind multicancer early detection test that can detect a sign shared by more than 50 cancer types. It can also predict the tissue type or organ associated with the signal to help health care providers determine next steps. Ropes & Gray’s health care team, led by David Peloquin, has advised GRAIL on research, regulatory and privacy matters.

Leadership on Clinical Research through the MRCT Center

The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard is a longtime pro bono client of the firm, co-founded in 2009 by health care partner Mark Barnes and Dr. Barbara Bierer, the faculty director of the MRCT Center and a professor of medicine at Harvard Medical. The MRCT Center functions as an independent study and applied policy center that convenes collaborative academic medicine, industry and government teams to address critical issues in the conduct and oversight of clinical trials, including in the research for cancer treatments. Its work has included addressing diversity, inclusion, and equity in clinical research; providing resources for patients and participants in clinical trials; advising on issues of quality and transparency, including around data sharing; analyzing the impact of emerging global data privacy laws on clinical research, and helping the research community build capacity for clinical trials by harmonizing competencies for clinical research professionals. Barnes, with health care partner David Peloquin, leads Ropes & Gray’s relationship with the MRCT Center.