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.
