Toggle Mobile Navigation

7th CROWN Congress Mentioned in Interview With Janssen’s GxP Systems Strategy Director

ExL Events is so excited to thank Applied Clinical Trials for mentioning our 7th CROWN Congress once again in a new interview with Joe Pollarine, Head of GxP Systems Strategy Director at Janssen — who recently presented on CRO oversight models at the 8th Clinical Quality Oversight Forum. ExL’s 7th CROWN Congress takes place on January 23–25, 2018 in Philadelphia. In this new interview, Pollarine expanded on CRO oversight models and more.

“Most trial data is typically held in a CRO’s technology systems, and sponsors access them through portals which allow them to conduct their own assessments,” Pollarine explained when asked what analytical systems and methodologies support strong oversight. “Janssen requests key data to be periodically transferred and integrates it into our in-house environment. With access to these data, Janssen can use a proprietary dashboard built on a visualization platform to efficiently monitor key variables (e.g. volume of protocol deviations, number of patients enrolled at a site over time etc.) across all sites in a trial to look for potential site performance issues which are then researched to better understand the root cause.”

He continued: “The insights gained through these reviews can then be used as intervention points to have targeted discussions with CROs to understand why an investigator site’s (or even study) performance is not as expected. Oftentimes, these insights can lead Janssen teams to identify data irregularities, site performance issues, and possibly even CRO performance issues. Regardless of whether after investigation an underlying issue is identified, these analytical data reviews are a way Janssen can maintain strong oversight of outsourced trials as they lead to ongoing communication and remediation (as needed) with CRO trial teams.”

Pollarine discusses the difference between Minimal and Strong sponsor oversight at Janssen, inspection readiness, and more in this new interview. To find out more on this topic from an industry professional and previous ExL speaker, read more right here!

posted in ExL Events News
tagged with

live chat software