Site monitoring activities are one of the major cost drivers in clinical trials today. To sponsors, this elevates the significance of improving the efficiency and effectiveness of trial monitors or CRAs to execute tasks such as ensuring trial site compliance, resolving clinical trial site issues, and supporting clinical study sites to deliver accurate data quickly for trial analysis enabling strategic decisions.
A study with 18 Germany-based pharmaceutical companies on the implementation of oversight and utilizing Vendors/CROs, showed about 70% use in Monitoring, 56 on study management, and 44 on data management as top 3 areas.
The only source is EDC (and maybe CTMS in some companies) for you to “oversee or work” with CROs/vendors. That’s about 50% of the information. The other half is in Documents/Text (Monitoring Visit Reports, site files, others). You’ll not have time to look at every document or every monitoring visit report for sure. In addition, you are paying CRO to do this task. This is both a lost opportunity (good sites, TA opportunities with PIs, and more) and potential landmines (issues or risks documented in MVRs but only come out during site audits by you or by HA).
No matter what templates you (or your CRO) use for monitoring reports or who authors them, TULA is AI-driven to capture the potential risks and signals early to help you mitigate risks faster. All these are presented to you as action items and you can adjust on what you want to see and what can be pushed to CRO automatically to check (thereby saving your time).
You need a tool that can combine structured and unstructured data holistically for you to get insights (that otherwise would get missed) and risks proactively. TULA is an AI-driven performance, oversight, risk, and quality compliance system that combines data & text effectively for you to leverage day 1.