Applied Clinical Trials
Risk-based monitoring was in Trans-Celerate BioPharma's sights since the pharmaceutical company collaborative was announced in September 2012.
Risk-based monitoring was in TransCelerate BioPharma's sights since the pharmaceutical company collaborative was announced in September 2012. TransCelerate made good on its promise and delivered its first position paper early this month and can be accessed along with the public review survey here: http://bit.ly/182ItxJ. The organization's 16 member companies will pilot its RBM methodology, with multiple pilots already in motion. Following completion of pilot activities, TransCelerate plans to issue a future position paper clarifying the effectiveness of its approach.
According to TransCelerate, the RBM paper outlines a standard approach for risk-based monitoring that can be adopted for any type, phase, and stage of clinical trial, resulting in enhanced patient safety, quality clinical data, and new efficiencies. The position paper was developed in response to draft guidance from the FDA and EMA, and both agencies have reviewed the paper.
TransCelerate's RBM methodology provides a framework and tools to help identify, manage, and mitigate clinical trial risks. The tools include the Risk Assessment and Categorizaton Tool and the Integrated Quality and Risk Management Plan. Rehbar Tayyabkhan, Executive Director at Bristol-Myers Squibb and RBM Project Lead for TransCelerate, said, "We also are sharing an approach that enables a balance between off-site/centralized study monitoring and on-site activities at the investigative site. This allows for a more targeted approach."
Tayyabkhan will be on hand in late October at CBI's Risk-Based Monitoring in Clinical Trials conference to discuss TransCelerate's risk-based work stream, the processes and operational considerations, as well as future expectations. Tayyabkhan will be joined on this panel by Andy Lawton, Global Head of Data Management, Boehringer Ingelheim, and Craig Wozniak, Vice President, North America Clinical Operations, GlaxoSmithKline. To learn more about the conference, please visit www.cbinet.com/RBM.
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.
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.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.