FDA Staff Gain Rapid Clinical Insight Capability Leveraging the TriNetX Real-World Data and Analytics Platform
Cambridge, MA, July 14, 2020 — TriNetX, the global health research network that revolutionizes clinical research and enables discoveries through the generation of real-world evidence (RWE), today announced the signing of an agreement with the FDA Sentinel Program. FDA, through its Sentinel Program, is licensing the full TriNetX analytics suite that provides direct access to de-identified real-world data (RWD) in the TriNetX U.S. network for the FDA’s Office of Surveillance and Epidemiology (OSE) and the Sentinel Operations Center (SOC) led by the Harvard Pilgrim Health Care Institute (HPHCI).
The contract builds on TriNetX’s growing relationship with the FDA. The agency’s epidemiologists are already directly leveraging the TriNetX platform to access RWD and conduct in-depth analyses to monitor the use of critical drugs for COVID-19 patients in an effort to monitor potential drug shortages and to better understand the natural history of the disease. TriNetX is working closely to support the Sentinel Initiative, a national data network set up by the FDA and led by HPHCI to monitor the safety of regulated medical products.
“There is clearly a need for a large, frequently refreshed, and up-to-date EMR dataset to support FDA’s response to COVID-19,” said Jennifer Stacey, Vice President, Clinical Sciences at TriNetX. “Being able to directly and interactively query TriNetX data in real-time and to answer questions quickly provides the agency with a unique capability and is playing a role in FDA’s response to the COVID-19 pandemic. We are excited about this partnership which aims to further support FDA’s real-world data and evidence initiatives.”
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. Sentinel is the FDA’s largest RWD platform for conducting post market safety analyses.
“We recognize the importance of TriNetX to achieving the goals we have set for the Sentinel program, in particular incorporating EMR data into Sentinel to support FDA needs,” said Jeffrey Brown, PhD, from the Department of Population Medicine at the Harvard Pilgrim Health Care Institute and Harvard Medical School. “This new contract provides FDA and the HPHCI team access to TriNetX’s growing network of EMRs that we expect to leverage for multiple purposes in the coming months and years.”
“We are extremely pleased to extend our relationship with the FDA and the Harvard Pilgrim Health Care Institute,” said Michael Sullivan, Director of U.S. Public Sector at TriNetX. “This partnership ensures that real-world data from TriNetX’s network of leading healthcare organizations will continue to inform FDA’s COVID-19 response and support regulatory decision-making at the highest levels of the FDA.”
TriNetX is the global health research network that connects the world of drug discovery and development from pharmaceutical company to study site, and investigator to patient by sharing real-world data to make clinical and observational research easier and more efficient. TriNetX combines real time access to longitudinal clinical data with state-of-the-art analytics to optimize protocol design and feasibility, site selection, patient recruitment, and enable discoveries through the generation of real-world evidence. The TriNetX platform is HIPAA and GDPR compliant. For more information, visit TriNetX at www.trinetx.com or follow @TriNetX on Twitter.
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 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.
Harvard Pilgrim Health Care Institute