Real-time performance and risk management at the portfolio, site and study level
PHILADELPHIA – June 7, 2018 – ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, today 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 visualizes 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.
For more information on ERT’s Trial Oversight solution, and to download a complimentary best practice guide, “Ensuring Risk-Based Quality Management in Clinical Trials,” visit https://www.ert.com/trialoversightsolution/.
ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that its customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising standards.
Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. In 2017, ERT supported more than 60% of all FDA drug approvals. Pharma companies, biotechs and CROs have relied on ERT solutions in 13,000+ studies, spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly ─ and with confidence.