We have extensive experience negotiating the often complex issues relating to clinical research. We advise clients on compliance with regulatory requirements governing clinical research, including clearance processes, subject recruitment, safety reporting, privacy, and good clinical practice issues. We negotiate complex agreements with CROs and other clinical trial vendors, as well as site and investigator agreements, and we have extensive knowledge of best practices in such arrangements. Our firm provides assistance in inspections, data integrity investigations, and civil penalty and investigator disqualification proceedings. We assist clients in complex investigations relating to fraud and safety issues in clinical trials, including high-profile matters involving civil and criminal proceedings, congressional investigations, and media scrutiny. We also help in extensive proactive reviews of global clinical and nonclinical research functions.
Sophisticated Advice: Our team has encountered the most challenging clinical research issues, from responding to allegations of fraud in a massive real-world trial to addressing emerging safety issues in small gene therapy studies.
Global in Scope: Arnold & Porter lawyers routinely support clients in setting up and addressing issues arising in global clinical trials, from contractual arrangements to issues arising in site inspections to individual investigator misconduct.
Benchmarking: Our deep knowledge of the field and breadth of research law experience gives us a valuable perspective in helping clients understand and gauge research risks and mitigations.