ERT, a global data and technology company that minimises uncertainty and risk in clinical trials, has introduced its advanced Trial Oversight solution, a performance and risk management application that enables clinical trial sponsors and contract research organizations (CROs) to gain greater predictability, protection and control of their studies.
Built from the ground up, ERT’s new Trial Oversight solution integrates all clinical and operational data in real-time to support today’s most complex clinical trials.
Data are accessible to users via an intuitive, role-based interface that visualises performance metrics, key risk indicators (KRIs), and study milestones to provide a holistic view of risk and performance at the portfolio, study, and site levels.
The application comes with pre-built key performance indicators (KPIs) and KRIs, designed to protect sponsors from unwanted study deviations that can be assessed at the portfolio, site and study level.
These KPIs and KRIs are highly configurable and informed by industry best practices and regulatory requirements from leading consortia such as TransCelerate Biopharma and Metrics Champion Consortium (MCC).
Predictive analytics and automated alerts identify areas for proactive risk mitigation, enabling study managers to stay ahead of and task critical actions.
Paired with a closed-loop reconciliation process to ensure tasks have been properly completed, study managers can effectively maintain control of study performance.
“Trial sponsors and CROs typically use a retrospective view of performance and risk, coupled with manual processes, which limits their ability to proactively manage their studies,” says David Coman, Chief Strategy Officer, ERT.
“ERT’s Trial Oversight solution utilizes real-time data and puts predictability, protection and control at their fingertips. This enables earlier issue identification and response than previously possible, keeping clinical trials on time and fully compliant with regulatory requirements.”
As with the recently introduced ERT Business Intelligence suite, ERT’s Trial Oversight solution is enabled by the company’s proprietary data lake architecture, which includes an operational data store, master data management, and advanced data management capabilities hosted by Amazon Web Services (AWS) in a HIPAA- and FDA-compliant cloud platform.
This scalable infrastructure serves as the foundation for all of ERT’s ongoing and future product development initiatives.