Guiding Clients Through the Process of Clinical Trials
In 2014, Pullman & Comley’s Health Care practice provided regulatory and contracting advice and assistance to our hospital clients involved in conducting clinical trials of new drugs and medical devices, prior to the Federal Drug Administration’s (FDA) approval. A significant component of the firm’s work in bioscience research includes ensuring that hospitals that perform clinical trials are compliant with FDA, National Institutes of Health and Federal Office of Human Subjects Research standards. In addition to working closely with hospital clients negotiating clinical trial contracts proposed by pharmaceutical companies and other study sponsors, the firm also evaluates and provides recommended revisions to our clients’ clinical trial policies and practices. Our attorneys also have served on, and acted as legal advisors to, our client’s institutional review boards that must approve proposed clinical trial research protocols prior to their initiation at the hospital, including in one most recent example, assisting one of our hospital clients undertaking a study in possible game changing oncology research.