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

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 provides the pharmaceutical industry and its service providers with “peer-based” guidance and best-practices for the adoption, use, and outsourcing of risk-based monitoring. It contains:

Best Practices & Operational Impact of RBM

Sponsors’ interests in and use of RBM studies, why RBM is gaining momentum, what is driving adoption, and a high-level look at sponsors’ expected financial and operational outcomes of RBM studies

Real-world lessons-learned, including advice for individuals and companies wanting to implement RBM studies

Study types that are seen as most appropriate for RBM and which department are involved in the planning of these studies

On-the-ground suggestions for improving the RBM regulatory and training processes

Critical technologies are most important to running a successful RBM-based trial and which are most difficult to implement

The percentage of RBM studies outsourced, the preferred types of service providers, and most important service provider attributes effecting selection

For sponsors: Use this information to help drive RBM adoption in your organization, avoid pitfalls that might stagger RBM growth, Inform your data infrastructure strategies, and benchmark the use of RBM.
  
  For service providers: Better understand the inner working of sponsors as it relates to the adoption of RBM models and craft better messages and service offerings to account for these views.