Regulation of Clinical Research
We have extensive experience working effectively with clients on the increasingly complex issues relating to clinical trials. Our practice routinely advises clients on compliance with regulatory requirements governing drug and device research, including clearance processes, subject recruitment, safety reporting, privacy, and good clinical practices issues. We have negotiated complex agreements with CROs and other clinical trial vendors, as well as site and investigator agreements, and have we have extensive knowledge of best practices in such arrangements. Our firm has provided assistance in FDA bioresearch monitoring inspections and civil penalty and investigator disqualification proceedings. We have assisted 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 have also helped clients in extensive proactive reviews of global clinical trial functions and programs for compliance with legal requirements and mitigation of risk.