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

Abstract

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). As part of the operational strategy, Janssen, PAREXEL, and IQVIA jointly developed an outsourcing manual to consistently guide trial delivery. The outsourcing manual recently adopted policies and implementation guidelines for RBM. Clarity around roles and responsibilities as well as a good understanding of system capabilities and data flows, especially where there are shared systems between the sponsor and CRO, are found to be key success factors. Besides possible organizational changes and the development of mutual processes and system capabilities, the human element is not to be underestimated. Managing the changes in processes and change in mind set within both the sponsor and CRO organization is crucial to successful implementation of RBM, and our experience in this regard forms the basis of this paper.