Our clients range from startups needing foundational clinical research regulatory advice, to established pharmaceutical manufacturers and biotechnology and medical device companies needing a broad range of ongoing legal support. We counsel our clients on the complex array of legal issues affecting clinical research activities. We understand the dynamics of relationships involving governmental agencies, industry sponsors, principal investigators, and institutional review boards (IRBs).

The numerous US laws and regulations aimed at curbing health care fraud are intended partly to ensure the integrity of research projects, research data, the health and safety of research subjects, and the proper use of federal grants. Research compliance has therefore become a priority for organizations sponsoring or conducting research or providing services to research participants. Wiggin and Dana has guided these organizations through the regulatory maze, using our experience in the broad range of strategic, financial, operational, and legal components that affect clinical research. And, when necessary, we defend clients in litigation and government investigations involving clinical-research issues, and we advise clients in conducting internal investigations and voluntary disclosures concerning research matters.

Our full-spectrum clinical research compliance and regulation legal services address areas such as

  • IRB review
  • Informed consent
  • Adverse-event reporting
  • Conflicts of interest
  • Fraud and abuse
  • Grants and contracts
  • Research misconduct
  • Billing and reimbursement
  • Privacy, including HIPAA and other applicable state and federal laws, and the EU's General Data Privacy Regulation (GDPR)
  • Government investigations