Cyntegrity Launches MyRBQM
Cyntegrity, Germany’s provider of intelligent risk-based quality management (RBQM) solutions to the Life Sciences industry, has announced the launch of MyRBQM Portal - a full-service business intelligence and analytics cloud specifically designed for clinical trial purposes.
MyRBQM Portal responds to the practical implementation needs of CROs, Biopharma and MedTech enterprises transiting to risk-oriented processes mandated by today’s GCP guideline ICH E6 (R2) and EU MDR.
For more information, visit www.cyntegrity.com
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.
