Clinical Research

Bench research, animal research, and clinical trials have unique business, regulatory, operational, and ethical considerations that often require highly specialized advice. Our attorneys have been general counsels of major universities and research hospitals, senior lawyers in the federal government, IRB members, and an advisor to a foreign government on national research policy. Through these in-house experiences, our attorneys have had administrative responsibility for clinical trial regulatory affairs, technology transfer offices, and an IRB office. We advise hospitals, universities, life sciences companies, and foundations with the following:

  • Regulatory aspects of clinical trials, including the Common Rule, Food and Drug Administration regulations, and clinical trial registration.
  • Regulatory aspects of research with animals.
  • Funding for research, including federal and private grants and Medicare billing.
  • Human research protection program design and implementation.
  • IRB operational improvement and reliance agreements, including to facilitate single IRB mandates.
  • The creation and sharing of data and tissue repositories.
  • Institutional compliance auditing.
  • Investigations of alleged research misconduct or noncompliance with federal grant requirements.
  • Conflict of interest policy development and implementation.
  • All types of clinical trial, investigator-initiated research, and research collaboration agreements.
  • Acquisitions, consolidations, or other corporate restructurings that involve the transfer of, or otherwise impact, clinical research operations

In addition, we have deep experience with the globalization of biomedical research. In addition to structuring research collaborations in “traditional” jurisdictions like the UK, EU, Canada, and China, we have on-the-ground experience establishing clinical trials and data and specimen collection projects throughout Africa, Asia, and the Middle East, as well as experience establishing research and medical partnerships on six continents.

Audrey J. Anderson
Counsel
Jaime L. Barwig
Member
Tabitha L. Green
Associate
Clint D. Hermes
Counsel
Elaine C. Naughton
Associate
Todd R. Overman
Member
R. Gregory Parker
Member
Dawn Perez-Slavinski
Associate
Angelique Salib
Associate
Danielle M. Sloane
Member
Whitney Snow
Associate
Nesrin Garan Tift
Member
Janelle D. Waack
Member