Center for Clinical Research Grows Under Peters' Leadership
The Center for Clinical Research (CCR) continues to enhance many service lines and recently announced the availability of an external FDA consultancy firm to guide Northwestern University investigators with FDA submission planning. The firm offers various subject-matter experts in medical devices, investigational drugs and biologics, and combination products. The CCR Regulatory Team can now support annual submissions to the FDA, as well as amendments not requiring consultation. The CCR Finance Team now offers a separate Study Tracker budget build-out fee for study teams. Additionally, CCR Finance and Regulatory have gained considerable experience in executing cellular therapy protocols.
The ClinicalTrials.Gov Support Team expanded outreach efforts to study teams and launched a series of how-to videos to answer frequently asked questions. Northwestern Medicine’s Clinical Research Unit continues to be an option for many of the nearly 7,000 clinical trials taking place annually at Northwestern.
“The CRU offers exceptional support, ensuring research teams can conduct their studies efficiently while providing outstanding, detailed care to the study subjects,” says Anju Peters, MD, CCR director. “One of the great advantages of the NM CRU is that its mobile nurses offer flexible, on-site support to research teams across the hospital, ensuring that clinical studies are conducted seamlessly wherever they are needed.”
