Informing the drug development and commercialization industry Cary, N.C. – May 9, 2013 – Industry Standard Research (ISR) released a new market research report today entitled “Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing.” 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 ISR 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.” ISR’s 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.” More information about this report is available on ISR’s website at https://isrreports.com/industry-reports/risk-based-monitoring-industry-guidance-on-adoption-use-and-outsourcing. About Industry Standard Research Industry Standard Research is the premier, full service market research provider to the pharma and pharma services industries.  With over a decade of experience, ISR delivers an unmatched level of domain expertise.  For more information about our off-the-shelf intelligence and custom research offerings, please visit the company’s Web site at www.ISRreports.com, email info@ISRreports.com, or follow us on Twitter @ISRreports.

ISR CUSTOMERS