Clinical Research
Our clients range from startups needing clinical research transactional and regulatory advice, to established biotechnology, pharmaceutical 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, medical and academic collaborators, principal investigators, and institutional review boards (IRBs).
The clinical research contracting process can be daunting. Our team of attorneys routinely counsel clients regarding, and assist in negotiating, various agreements including service agreements with contract research organizations, clinical trial agreements with institutions and investigators, and a broad spectrum of other clinical research agreements including sponsored research, investigator-initiated research, and federal collaborative research.
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. When issues arise, we represent 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 clinical research legal services include:
- Informed consent
- Conflicts of interest
- Fraud and abuse
- Defamation
- Research Agreements, including clinical trial, sponsored research, and investigator-initiated research
- Grants
- Research misconduct
- Billing and reimbursement
- Government investigations
- Privacy, including HIPAA and other applicable state and federal laws, and the EUโs General Data Privacy Regulation (GDPR)
