PHILADELPHIA, Sept. 17, 2014 /PRNewswire/ -- TransCelerate BioPharma Inc. ("TransCelerate") announced today the publication of its two most recent manuscripts on risk-based site monitoring ("Risk-Based Monitoring" or "RBM"), developed jointly by its 19 member companies. Both manuscripts have been accepted and published through the Drug Information Association's Therapeutic Innovation & Regulatory Science journal. In these papers, TransCelerate provides in-depth insights into two specific concepts pertinent to RBM methodology – central monitoring and technology enablement. To continually refine its previously published RBM methodology, TransCelerate leverages the lessons learned from ongoing clinical studies using the methodology. Access to the two new manuscripts is available here andhere.
TransCelerate's RBM methodology is based on the notion that shifting monitoring processes from an excessive concentration on Source Data Verification (SDV) to comprehensive, risk-driven monitoring that uses a combination of Central, Off-site and On-site monitoring activities, will increase efficiencies, enhance patient safety and data integrity while maintaining adherence to good clinical practice (GCP). Despite varying approaches to implementation of centralized monitoring, there are some common elements that can be considered. As one of two expected publications on centralized monitoring, the first publication provides insights into recommended operational models that are based on actual member company experiences.
The second manuscript describes technology considerations to effectively facilitate the implementation of TransCelerate's RBM methodology. Combining the RBM methodology with the appropriate technologies is critical for success. Having the right technology to collect and aggregate data, provide robust analytics and to track issues are important to demonstrate that a quality management framework exists. As organizations scale the RBM methodology across their portfolio, this second manuscript provides some high level recommendations that can be taken into account when building an integrated technology solution.
"As the TransCelerate RBM initiative has outlined, successful implementation of risk-based monitoring is dependent on being able to operationalize the concepts effectively through multiple considerations, including process, people, and technology. Risk assessment, central monitoring and technology to scale the methodology are all important for success," said Brett Wilson, Associate Director, Business Operations at Bristol-Myers Squibb and RBM Project Co-Lead for TransCelerate. "By elaborating on these two supplemental pieces related to central monitoring and technology designs, we continue to focus and share best practices that will enable more effective adoption of the methodology."