ERT Expands eCOA Solution

Applied Clinical Trials

ERT announced a preferred partnership with the neuroscience technology company, Cogstate, Ltd. The collaboration enables ERT to expand its electronic Clinical Outcome Assessment (eCOA) solution with digital cognitive endpoint measurement to improve safety and efficacy assessment in clinical trials, including capabilities for at-home testing.

Cognition is a combination of brain processes that are critical for almost every aspect of life, such as learning, attention, memory, language, reasoning, and decision making. Conventional assessments of cognitive endpoints have historically been vulnerable to complexities, variability, and error. Plagued with issues ranging from non-standardized administration and rater bias to manual scoring, these assessments are less likely to yield reliable and conclusive results. By delivering Cogstate’s proven digital brain health assessments on ERT’s eCOA platform, trial sponsors can overcome these issues and capture higher quality data to support the development of treatments for CNS and other disorders.

“Pharmaceutical researchers and regulators are increasingly focused on understanding the impact new treatments have on the brain, so now more than ever there is a need to use digital technologies to make cognitive assessments more rapid, reliable, accessible and actionable,” said Jim Mahon, Vice President and Chief Strategy and Marketing Officer at ERT. “By leveraging Cogstate’s digital CNS assessment through ERT’s eCOA platform, sponsors can dramatically streamline the measurement of CNS clinical outcomes, increase the quality of data, reduce patients and site burden by eliminating the need for duplicate hardware, log-ins and support desks, and gain the flexibility of remote administration for virtual visits.”    

The Cogstate system includes highly automated neurocognitive tests with integrated analytics for understanding drug-effects related to areas of brain function such as attention, processing speed, motor function, executive function, and multiple aspects of memory. Cogstate’s digital assessments are delivered in the same eCOA application and visit workflow as ERT’s patient reported, clinician reported, or observer reported outcome assessments, overcoming the limitations of manual cognitive assessments and providing speed, efficiency, and data quality benefits for clinical trial sponsors. 

“ERT is renowned for delivering the reliable patient assessment data clinical trial sponsors need to confidently evaluate the safety and efficacy of new drug candidates,” said Brad O’Connor, CEO of Cogstate. “We’re pleased to collaborate with them as they expand their CNS measurement capabilities and leverage digital technologies to deliver more precise cognitive assessments, ultimately helping researchers bring new treatments to patients in need.”