Article | December 4, 2018

Building Faster, Patient-Centric Studies In A Changing Regulatory Environment

Source: Cenduit LLC

By Cindie Kazmer, Senior Director, Project Management, Cenduit


One of my favorite things about working in the eClinical and biopharma industry is the opportunity to improve the lives of patients through working in close collaboration with sponsors and other technology providers. Last month I attended the IRT USA 2018 conference in Philadelphia, where we as an industry group focused on exactly that.

IRT USA conference Chair Craig Mooney, Director of IRT at Bristol-Myers Squibb, discussed how study complexity is growing, combined with the increasing use of amendments to get studies deployed faster. He also highlighted how our industry is experiencing increased scrutiny amid the changing regulatory landscape. (Also at IRT USA, Cenduit’s Andrew Rohrbaugh, Director of Client Delivery, and Chris Gent, Associate Director of Operational and Process Excellence, discussed how to put the patient first when approaching System Change Requests. (SCRs)

In his thought-provoking keynote, among the many important topics Craig covered on the state of the industry, two themes in particular resonated with me:

1) The need for better project management – with people at the center of technology planning and study management

2)  Never losing sight that the patient is at the center of everything we do