Strategic deals fit with regulators' risk-based site monitoring

Ben Dudley, alliance management exec at Covance, made the comments at Partnerships in Clinical Trials in Hamburg, Germany.

He argued that for CROs regulators' adoption of risk-based site monitoring is "transformative rather than evolutionary" ​because they can accommodate this type of oversight by integrating regulatory, quality assurance and clinical operations teams.

He told Outsourcing-pharma.com a strategic partnership with a CRO is a natural environment for such harmonisation because governance teams already work together to integrate functions. The model is also complementary because it leverages knowledge from both companies, he added.

“Embedding in the functions is very important for risk-based monitoring,”​ said Dudley, executive director of alliance management for Covance.

“If you asked the regulatory strategy team or the QA (quality assurance) function you’d get a very diff response in terms of risk-based monitoring than if you asked clinical operations function for instance.​ It’s important that all of these stakeholder teams are involved early on and its crafted around their needs as well as the organisation."​

He added that if the governance sits at business unit leadership level when the decisions are made, it is much easier to unify all components.

A new inspection model​

Dudley said risk-based site monitoring is gaining more importance thanks to a recent regulatory interest in replacing “one-size-fits-all” ​monitoring - by which site-monitoring visits are carried out routinely once every four to six weeks - with a more flexible model which focuses on trial-specific risks.

Recent draft guidances from the US Food and Drug Administration (FDA)​ and the European Medicines Agency (EMA)​ instead suggest the frequency and intensity of site monitoring should be determined by aspects such as therapeutic area, study design and  the research site's history and experience.

However because of the flexibility of risk-based monitoring - which means trials are treated on a case-by-case basis - Dudley remains uncertain as to the future of the model in legislation.

“They are draft guidances at the moment and I think they will eventually be released as final, but in terms of whether these will transfer into regulation I think it’s anyone’s guess,”​ he told us.

He added that though there is no “clear expectation” ​of the process that will be implemented at the moment, he believes dossiers submitted in the future will be required to demonstrate the researchers have prospectively tracked and managed the risk.

“Although there’s variability there will be expectation that those risks have been covered."​