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

  • ID: 2739725
  • April 2013
  • 145 Pages
  • Industry Standard Research (ISR)
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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.

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Table of Contents

Copyright and Usage Guidelines
Respondent Demographics and Qualifications
Major Sections
Executive Summary
RBM Awareness and Definition
Familiarity with RBM (before given industry definition)
Familiarity with RBM (after given industry definition)
Respondent-defined definition of RBM
Best Practices & Operational Impact of RBM
Study characteristics best fit for a RBM study
Preferred phase for risk-based monitoring
Appropriateness of RBM: interventional & non-interventional studies
Roles involved in the risk evaluation/assessment process
Advice for those conducting RBM studies for the first time
Lessons-learned to improve RBM
Improving the regulatory aspects of RBM trials
Improving the monitoring operations/ execution aspect of RBM trials
Relative speed of the pre-trial regulatory trial planning process
Change in the number of planning/ interactions with regulatory bodies
Difficulty training employees in risk-based monitoring
Top five triggers companies use in risk-based monitoring
Use of specific task forces for RBM
Leading departmental support for RBM
Sponsor Perception and Use of RBM
Riskiness of RBM from an operations and regulatory standpoint
Overall interest in risk-based monitoring
Rationale for being interested in RBM
Rationale for non-interest in RBM
Percent of studies using risk-based monitoring
Cost-benefit of risk-based monitoring
Catalysts for initial RBM use
Adoption momentum of risk-based monitoring
Rationale for gaining momentum
Rationale for losing momentum
Driving adoption of risk-based monitoring
Top barriers while conducting risk-based monitoring
Top reasons that are hindering risk-based monitoring
Top benefits to conducting risk-based monitoring
Centralized monitoring use
Impact of adoption of centralized monitoring on RBM adoption
General opinion of using risk-based monitoring
Data and Technology
Most important data-related capabilities
Hardest data-related capability to implement
Most important data components of risk-based monitoring
Recommended technical improvements for RBM studies
Outsourcing Environment
Percent of clinical development outsourced
Percent of clinical monitoring outsourced
Frequency of outsourcing monitoring of RBM studies
Preferred type of service providers
Best type of outsourcing partnership for RBM
Service provider proof-points
Preference between therapeutic vs RBM vs data analytics
Important service provider attributes
Use of regulatory consulting service providers
RBM Economics
Save money with RBM?
Estimated monitoring costs saved using RBM
Investigative sites: risk-level assessment
Clinical studies: risk-level assessment
Respondent Demographics
Company type
Role and responsibility
Primary area of responsibility
Involvement with risk-based monitoring
Past and future use of risk based monitoring
Job level
Therapeutic area responsibilities
Phase responsibilities
About Industry Standard Research

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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.

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