Our clinical research lawyers recognize that quality health care begins with excellent clinical research. With heightened public scrutiny and ongoing governmental enforcement, conducting clinical trials and other forms of research has become subject to an increasingly complex maze of regulations. Our team of lawyers, scientists and policy analysts has the experience and vision to help clients maintain compliance in an ever-changing regulatory environment.
We work with various stakeholders in the life sciences and health care communities, including pharmaceutical and medical device manufacturers, biotechnology companies, contract research organizations, clinical laboratories, research associations, research support managers, hospitals and academic medical centers, independent physician groups, faculty, practice plans, and institutional review boards.
We collaborate with clients to devise and implement efficient and practical strategies to ensure compliance with applicable regulations, including the following:
- Advising clients on compliance with FDA’s human subject protection rules, requirements issued by HHS’s Office for Human Research Protections and related state regulations.
- Advising clients on compliance with data privacy requirements in the conduct of medical research.
- Advising on federal and state fraud and abuse compliance in the development of medical research collaborations between pharmaceutical and medical device manufacturers and health care providers.
- Advising clients on regulatory issues related to the collection of biological samples, the establishment of biological repositories and the international transfer of biological samples.
- Assisting research institutions and research sponsors in the design and implementation of research compliance programs.
- Drafting and negotiating industry premarket and postmarket clinical trial agreements and registry site participation agreements on behalf of both trial sponsors and research sites.
- Drafting and negotiating registry database agreements and data license agreements.
- Preparing and negotiating research informed consent documents.
- Drafting contracts between major research institutions and various service organizations to support the implementation of research protocols.
- Advising research sites and research sponsors responding to “whistleblower” allegations.
- Advising clients on issues relating to research subject injury liability, including Medicare Secondary Payer rules.
- Communicating with policymakers on legislative and regulatory developments related to clinical research both in North America and the European Union.