Our Health Care Practice lawyers recognize that quality health care begins with quality research. With heightened public scrutiny and ongoing governmental enforcement, conducting research has become subject to an increasingly complex maze of regulations. Our team of lawyers, scientists and policy analysts possess the experience and vision to help clients maintain compliance in an ever-changing regulatory environment.
Our lawyers work with various clients - including academic medical centers, institutional review boards, clinical laboratories and research associations, device manufacturers, faculty physicians, pharmaceutical manufacturers and research support managers, among others - to devise and implement efficient and practical strategies to ensure compliance with the myriad regulations. We have helped research institutions and research sponsors design and implement research compliance programs, assisted with the formation and education of in-house task forces devoted to research compliance; drafted research policies and procedures on a wide variety of compliance issues; drafted and negotiated clinical trial agreements; prepared informed consent documents; drafted contracts between major research institutions and various service organizations to support the implementation of research protocols; advised research sites and research sponsors responding to “whistleblowers’” allegations; and communicated with policymakers on legislative and regulatory developments related to clinical research both in North America and the European Union.