The Brigham and Women's Hospital (BWH) is world renowned for cardiovascular research. Under the direction of Pinak B. Shah, MD, investigators in the BWH Cardiac Catheterization Clinical Trial Unit participate in more than 25 device trials each year, including “first in human” studies of the most innovative technologies, traditional prospective randomized trials, registries and observational studies.
According to Frederic Resnic, MD, MS, Director of the BWH Cardiac Catheterization Lab, Partners Clinical Research Office (PCRO) “is extraordinarily responsive, moves quickly to address concerns of investigators and sponsors and resolve issues expeditiously. PCRO protects investigators while responding well to sponsors.”
Sarah Hammel, the Cardiac Cath Lab’s regulatory manager, adds “PCRO is a tremendous resource to our research team for contract and budget negotiation. Karen Lodigiani, our PCRO agreement associate, and Jennifer Kim, our PCRO financial analyst, enhance our ability to secure the most advantageous monies and trial terms. They are a delight to work with. Karen addresses investigators’ concerns about contracts and accommodates their goals for trials in keeping with BWH policies. Jennifer helps us understand CMS rules and regulations. She allows us the freedom to build our budgets and also contributes an unbiased opinion to help us make smarter decisions.” |