TransCelerate BioPharma Inc. Publishes Risk-Based Monitoring Recommendations For Central Monitoring And Technology Considerations

Two Manuscripts Appear in Drug Information Association's Therapeutic Innovation & Regulatory Science

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 and here.

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."

TransCelerate's original position paper outlining a methodology for risk-based site monitoring was released in June 2013. The position paper, updates and all training materials can be found here.

About TransCelerate BioPharma Inc.
TransCelerate BioPharma Inc. is a non-profit organization dedicated to improving the health of people around the world by accelerating and simplifying the research and development (R&D) of innovative new therapies. The organization's mission is to collaborate across the global R&D community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of medicines. TransCelerate evolved from discussions at various forums for executive R&D leadership to debate current issues facing the industry and examine solutions for addressing agreed-upon common challenges. The founding member companies are AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group and Sanofi. Additional members that have joined since the inception of TransCelerate include Allergan, Inc., Astellas Pharma Inc., Biogen Idec, Cubist Pharmaceuticals, EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Forest Research Institute (a subsidiary of Forest Laboratories, Inc.), Medgenics, Inc., Shionogi & Co., Ltd. and UCB.

Membership in TransCelerate is open to pharmaceutical and biotechnology companies with Research and Development operations. Executive offices are located in Philadelphia, PA. For more information, please visit http://www.transceleratebiopharmainc.com/.

Media Contact:

Seema Kumar
Chair – TransCelerate BioPharma Inc. Communications Committee
(908) 405-1144
[email protected]

Shannon Caudill
(740) 281-3715 or (614) 378-9042
[email protected]

SOURCE TransCelerate BioPharma Inc.