As you may already be aware, a key recommendation in the latest revision to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH E6 R2), finalized in November 2016, is the use of a quality-based approach inclusive of risk-based monitoring (RBM). It also recommends centralized monitoring processes. These should complement and potentially allow you to reduce the extent and frequency of on-site monitoring, freeing up valuable resources and providing the opportunity to:
- Remotely access and analyze site characteristics and performance metrics
- Identify data trends
- Select sites and processes for targeted monitoring based on site performance
At Bioclinica, we believe you need the right technology solution to support RBM for improved operational efficiency and bottom line, increased compliance support and risk mitigation is key. However, I talk to many companies who are using RBM technology with inefficient processes and disparate systems, meaning they don't have the coordinated, comprehensive insights they need, and are unnecessarily taxing their resources. In fact, according to a recent survey of 255 clinical operation leaders, although 34% have an RBM initiative in place, 68% still manually aggregate data using spreadsheets and 89% manually implemented their RBM program. I've found that these home-grown, legacy systems are typically not designed or equipped to meet the expanding requirements of ICH E6 R2.
Another option is an off-the-shelf, cloud-based application that is ready-made for RBM; however, companies can struggle to understand the dynamics of these applications and how they align with their existing organizational processes to support ICH compliance. As I discussed in last month's blog, the sponsor bears the burden of making sure that the system validation meets regulatory expectations. Are you ready to do so with someone else's application?
So, if you're shopping for a new RBM technology, what should you look for?
Connected insights: Is all the data in one place for quick and comprehensive insights?
Common platform: Can you access your data anytime, anywhere?
Integrated application: Can you easily access all signals to action in one system, based on all data sources?
Enhanced compliance: Can you review the full audit trail of all data, including traceable transformation of structured and unstructured data, as well as the validation of the underlying algorithms and take appropriate actions?
Also, recent Transcelerate recommendations for an RBM system include exportable standard and customizable reports and visualizations, predictive analytics that can mine historical data and a user-friendly interface that supports the end-user responsibilities.
With the right RBM technology, you should be able to use one system to support the many requirements of ICH E6 R2 compliance, take advantage of the readiness functionality to drive a proactive approach to audit preparation and meet ICH section 5 requirements for a quality management system.
If you'd like to learn more about us and our RBM services and ClearSite technology, drop me a line at Kristin.Mauri@bioclinica.com. For help interpreting or implementing ICH E6 R2 requirements into your organization, contact The Avoca Group.