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:
Major Report Sections:
What You’ll Learn:
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.
Download the report here.