Abby Abraham, Vice-President – Clinical Solutions
Nicholas Hargaden, President
The adoption of risk based monitoring (RBM) in sponsored clinical trials has been driven by both regulators and industry bodies such as Transcelerate and Metrics Champion Consortium (MCC). Amongst the larger pharmaceutical companies and CROs, significant pilot programs have been completed and in some cases a broader roll out has started. However, the associated change management of the business processes and IT investment (often on-premise custom developed systems) can require a very heavy resource commitment. In this context mid-size and specialized CROs are challenged to make significant progress towards the use of RBM. Despite the support of regulators, small and mid-size biopharma are challenged to find mid-size CRO partners that are ready to implement RBM strategies.
In this paper we look at the barriers that have slowed adoption we outline some of the functional changes that will need to occur to refine the operational model to an organization’s specific needs and culture. This will support those currently developing their RBM adoption roadmaps.
- Barriers to adoption of RBM by mid-size CROs
- Breaking down barriers
- Business strategy
- Change management
- Technology interventions