Technology enabled methodology for oversight aligned with ICH E6 (R2)
Why CRO Oversight matters?
As a sponsor, you are responsible for the integrity of the data generated by your CROs & Vendors. Regulatory agencies are focused on how sponsors oversee the activities and ensure the quality of their Vendors. Sponsor clinical teams are often frustrated by vendors sending them too many reports, manual workflows, and often missing data. Within a rapidly changing clinical environment, the complexities of running clinical trials and their oversight will only increase. In this scenario, a new technology-based model is needed to adjust to the realities and demands of clinical trials both now and in the months and years to come.
TULA solves these problems by automating oversight and collaboration across studies, systems, and CROs at every stage to have full control over the flow of clinical trials.
Risk Mitigation Scoring
Early risk identification and mitigation by bringing scores for enrollment, productivity, compliance, and other metrics show how every site and CRO is performing.
Data from your CRO/Vendor
TULA has pre-built interfaces with most source systems (like EDC, IRT, CTMS, Excels) in the market so implementation is much faster. We take this integration and data alignment responsibility completely.
Faster Decision Making
You need not be a medical statistician or IT/software professional – all complex tasks involved in data analysis materialize in the background, and you just get an easy-to-understand report that enables you to make decisions and take actions in real-time.
Instead of building a duplicate infrastructure to oversee your CRO, we use predictive analytics to empower a targeted oversight strategy to mitigate potential risks before they become problems.
TULA can put you on the fast track to CRO Oversight process innovation