Risk-Based Monitoring

Over the past years, the clinical trial landscape has faced significant changes in response to globalisation, study complexity, regulatory restrictions and the advancements of technology. In light of all these changes, sponsors are seeking new ways of minimising costs and maximising efficiency during the drug development journey.

Monitoring is a process that always required a high volume of time and resources, usually assigned evenly to each individual site. Implementing a Risk-based Monitoring strategy allows sponsors to develop more robust monitoring procedures that will take into consideration sites of greatest risk and safeguard a successful study outcome. Risk-based Monitoring ensures the quality, integrity and safety in clinical development by identifying, calculating and addressing any possible risks along the way. This strategy that analyses any potential risks, gives the study team and Clinical Research Associates the opportunity to use their time more effectively and concentrate on more complex and valuable trial-focused issues.

In clinical research the best use of study and site data is key and the continuous flow of information is the best pathway to a successful risk-based monitoring approach. However, the communication within the study team is of equal importance. A monitoring plan should be put in place and all members need to have a clear understanding of the procedures and their role. The purpose of the plan is to communicate any risks to the broader team.

Centralised monitoring is an important component of Risk-Based Monitoring that promises fewer mistakes along the line, reduced costs as some of the processes are focused on the critical sites, better time management and therefore better use of resources and also cross-checks between the sites to recognise any potential errors or implementation of new practices.

Risk-based monitoring, if planned properly, can have numerous benefits for sponsors and eventually for drug development and patient safety. The shift towards Risk-based Monitoring is happening slowly across the industry but TCTC has totally embraced this approach in the interest of serving our Sponsors as efficiently and effectively as possible.

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Source:https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf.