Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing

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Jan 31, 2014, 01:22 ET

DUBLIN, January 31, 2014 /PRNewswire/ --

Dublin - Research and Markets (http://www.researchandmarkets.com/research/248gqk/riskbased) has announced the addition of the "Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing" report to their offering.

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ISR believes the rise of risk-based monitoring (RBM) is a result of several forces acting on the pharmaceutical industry. First, electronic data capture (EDC) technology is now the de facto standard for site/ patient data capture. Second, the patent cliff and declining R&D productivity rates have conspired to force pharmaceutical companies to look at ways to cut costs, while increasing efficiency. Third, regulators have begun to output guidance documents that center on alternative drug development models and processes (risk-based monitoring, adaptive trials, electronic data as source data), making it less risky for sponsors to employ these methodologies/ strategies.

This report offers the pharmaceutical and biotech industry, and its service providers peer-based guidance on the adoption, use, and outsourcing of risk-based monitoring.

The report was developed by surveying industry professionals with direct risk-based monitoring (RBM) experience and provides the pharmaceutical industry and its service providers with peer-based guidance to aid in the regulatory and expertise challenges the industry is currently facing.

While the report believes several industry factors are ultimately responsible for the continued momentum we've seen with risk-based approaches to clinical monitoring, respondents were very clear as to the main driver for using RBM: Reduced trial costs, explained Andrew Schafer, President of ISR. In light of regulatory uncertainty and a general lack of expertise, we anticipate the use of risk-based monitoring to rise in the future as sponsors look around the industry for best-practices and experts to assist them.

The report, which surveyed 78 industry professionals from sponsor organizations, aims to guide that uncertainty in the form of operational and strategic best practices. The report offers recommendations based on real-world lessons learned to anticipate both internal and external regulatory and operational hurdles, as well as identifies the studies, study characteristics, and service providers seen as "best fit" for RBM activities.

Believed to offer significant cost savings, it's no surprise that awareness of and interest in risk-based monitoring is high. Sponsors are, or should be, doing their due diligence on the topic to progress down the RBM path. Successful RBM implementation takes internal subject matter experts across many different disciplines within an organization and many are looking for CROs who have experience in not only operationally executing RBM studies, but for those who can/ will input on the design and strategies surrounding them.

For more information visit http://www.researchandmarkets.com/research/248gqk/riskbased