The 5th Annual Outsourcing in Clinical Trials (OCT) Nordics conference provided another outstanding opportunity to explore a beautiful city, stay in the world’s greenest hotel and gain additional insight into aspects of clinical trials that are important for my daily work and even those that don’t touch my daily eClinical life. The mix of representatives from long-established pharma, CROs, biotech and third-party vendors enabled refreshing conversations about how we can work together to improve our communication and move in synergy toward our shared goals.
In my daily work as the Business Analyst and Project Manager for CTMS, I help companies understand and implement their business requirements, including trial oversight. These requirements are always evolving, most recently with regulatory revisions such as the ICH GCP E6 (R2) Addendum, which puts the onus on sponsors to build quality into the design and operation of trial activities, such as monitoring, validation, source documentation and data management, and to demonstrate use of technological tools to ensure robust conduct, oversight, and reporting.
Therefore, I was particularly pleased to hear at OCT Nordics the details of how various sponsors and CROs have and are planning to implement additional trial oversight. At Bioclinica, I am working with sponsors and CROs in the EU to put in place central monitoring as part of CTMS implementations, to explicitly allow sponsors to demonstrate this additional level of trial oversight by bringing key data into a central repository for reporting purposes. CTMS solutions help to develop reporting solutions, both standardized and customized to sponsors’ or CROs’ specific requirements. Bioclinica’s OnPoint CTMS is one such system that lets you view and manage real-time operational performance.
Risk-based monitoring (RBM) as an integral part of trial oversight is also gaining greater traction within the industry and was a hotly discussed topic at the conference. RBM focuses on the specific risks to patient safety and trial success for each specific clinical trial rather than routine visits and 100% SDV, to make monitoring more efficient. It was great to hear sponsors talking about the results of completed trials that did not need to use 100% SDV because of the implementation of RBM and risk profile assessments for clinical sites. I also enjoyed sharing the details of our brilliant new RBM product ClearSite, which is being implemented by many current clients as a standalone product or in conjunction with OnPoint CTMS, with which it can bidirectionally transmit and receive data. As a result, I gained so much insight to pass on to Bioclinica’s RBM team!
Overall, it was a great event. I’m back in the UK now and feeling energized to facilitate the incorporation of what I learned into our products and practices so Bioclinica customers, old and new, can benefit.