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Halloran Clinical Operations Executive Brunch In Partnership with Neurocrine Biosciences | Accelerating RBM Adoption: Harnessing Momentum, Clearing Hurdles, and Planning for Implementation

Thu, Aug 25th 2022 - Thu, Aug 25th 2022, 11:30 am - 1:00 pm

Risk-based quality management (RBQM) is both a mindset as well as a critical system for managing data quality and ensuring patient safety throughout a clinical trial. It’s comprised of different components, each of which plays an important role in ensuring that risks are identified, mitigated, and, if possible, eliminated, through the entire study execution process. However, RBQM has not been widely or consistently adopted despite the availability of the guidelines developed by the International Council for Harmonisation (ICH).

The implementation of risk-based monitoring (RBM), a key component of RBQM, has lagged in the clinical trial industry. To better understand the state of RBM implementation across the industry, the Association of Clinical Research Organizations (ACRO) recently conducted a landscape survey among its member companies across 6,500+ trials. The implementation rates for the individual RBM components ranged from 8-19% with the most frequently implemented component being centralized monitoring and the least frequently implemented component being source document review (SDR).

When the COVID-19 pandemic emerged in early 2020, by necessity, many clinical trial sponsors moved to remote monitoring (another component of RBQM) with, as it currently appears, little or no reduction in monitoring effectiveness. Despite the proven benefits to reducing costs and shortening timelines without sacrificing trial integrity or patient safety, why haven’t many trial sponsors made the RBM leap? Why are many sponsors still evaluating when and how to implement some or all RBM components?

Please join executives from Neurocrine Biosciences during our virtual Clinical Operations Executive Brunch on Thursday, August 25th from 11:30 am – 1:00 pm ET on “Accelerating RBM Adoption: Harnessing Momentum, Clearing Hurdles, and Planning for Implementation.” The team at Neurocrine understands the importance and value of implementing RBM and will share their experiences – successes, hurdles, and “pull out your hair moments” – and the following points:

Our Virtual Brunch will be hosted by:

NOTE: This is an invite-only event. To request an invite, please click the more details link to email Halloran’s Event Manager.

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