Risk-Based Monitoring: Key Conditions in Collaboration Between Contract Research Organization and Sponsor.

Although risk-based monitoring (RBM) high-level definitions and processes are similar across the pharmaceutical industry, the practical implementation, organizational structures, naming of documents and processes, system capabilities, etc. can be different from company to company. Through an alliance-level relationship, Janssen, PAREXEL, and IQVIA have gained experience and developed best practices with RBM operational deployment, particularly regarding RBM setup and collaboration between sponsor and contract research organization (CRO).