Saturday, December 7, 2019

Saturday, December 7, 2019

TRINEtX: Named Technology Partner for FDA Sentinel System


TriNetX issued the following announcement on Oct. 7.

TriNetX, the global health research network that revolutionizes clinical research and enables discoveries through the generation of real-world evidence (RWE), has been named a technology partner in two coordinating centers of the FDA's Sentinel System, a national program that uses electronic health care data to monitor the safety of FDA-regulated drugs and other medical products.

The Harvard Pilgrim Health Care Institute (HPHCI) has led the Sentinel System since the inception of the initiative in 2009 and was recently awarded a five-year contract by the FDA that may reach $220 million over the next five years to continue to lead the Sentinel Operations Center and to develop a new Sentinel Innovation Center.

"We are pleased to continue leading the Sentinel System along with our collaborating partners," said Richard Platt, MD, MSc, Professor and Chair of the Department of Population Medicine at HPHCI and Harvard Medical School and Principal Investigator of the FDA Sentinel System. "We look forward to continuing these efforts and enabling Sentinel to grow in scope and scale over the next five years."

The Institute selected TriNetX as a Sentinel partner as a result of their search for collaborators who could bring new EMR data sources and innovative capabilities to Sentinel. TriNetX will partner with the Sentinel's Operations Center and will participate in the newly established Innovation Center which is involved with bioinformatics, advanced analytics, novel data sources, and randomized trial and RWE innovation.

"Our team is thrilled for the opportunity to work with the Harvard Pilgrim Health Care Institute and other partners to support the Sentinel initiative," said Michael Sullivan, Director of U.S. Public Sector for TriNetX. "By accessing TriNetX, the FDA will have the ability to gain a real-time understanding of patient populations, drug use and treatment patterns through our real-time EMR data network made up of the leading healthcare organizations in the U.S."

Sentinel is one of the FDA's premier evidence-generation platforms and has become a core feature of the agency's post-market safety system. It provides important new safety information to inform regulatory decision making and to ensure that the medicines patients receive are safe and effective. Sentinel is the FDA's largest real-world data platform for conducting post market safety analyses.

"We are honored to be part of this critical platform that the FDA uses to ensure patient safety," said Gadi Lachman, Chief Executive Officer of TriNetX. "We are pleased with the confidence HPHCI has shown in TriNetX in allowing us to play a part in the FDA's growing use of real-world data and real-world evidence."

About Harvard Pilgrim Health Care Institute's Department of Population Medicine

The Harvard Pilgrim Health Care Institute's Department of Population Medicine is a unique collaboration between Harvard Pilgrim Health Care and Harvard Medical School. Created in 1992, it is the first appointing medical school department in the United States based in a health plan. The Institute focuses on improving health care delivery and population health through innovative research and teaching.

About TriNetX

TriNetX is the global health research network that revolutionizes clinical research and enables discoveries through the generation of real-world evidence. TriNetX combines real time access to longitudinal clinical data with state-of-the-art analytics to answer complex research questions at the speed of thought. The TriNetX platform is HIPAA and GDPR compliant. 

Original source can be found here.

Organizations in this Story

TriNetX

More News

FDA Reporter