TRI Announces RBM Platform
Triumph Research Intelligence (TRI), based in London, UK and Raleigh, NC announces its Risk-Based Monitoring platform, Operational Platform for Review, Reporting and Analysis OPRA, for a combination of statistical calculations, data visualizations and operational activity management.
Triumph Research Intelligence (TRI), based in London, UK and Raleigh, NC announces its Risk-Based Monitoring platform, Operational Platform for Review, Reporting and Analysis OPRA, for a combination of statistical calculations, data visualizations and operational activity management. In general terms, OPRA uses data from the systems where trial data is typically stored to search for patterns and outliers in the data. The patterns are displayed to users in easy to read graphs which show how each site relates to the others within a set of data. Combinations of patterns yield a “signature” that provides insight into the behavior of the site attending to patients in a clinical trial. Identifying these signatures allows users of OPRA to assess the risk that the site poses to the patients and to the trial based on seemingly unrelated data already collected from the site. TRI says the new platform addresses regulatory concerns around evidence that companies are providing quality management over their use of RBM.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
