ERT Expands eCOA Solution for Higher Fidelity CNS Assessments

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Partnership with Cogstate delivers digital cognitive assessments to improve the speed and effectiveness of clinical trials

By delivering Cogstate’s digital brain health assessments on ERT’s eCOA platform, trial sponsors 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 there is a need for digital technologies to make cognitive assessments more rapid, reliable, accessible and actionable.” -Jim Mahon, VP, Chief Strategy Officer, ERT.

ERT, the global leader in clinical endpoint data collection, today announced a preferred partnership with the leading neuroscience technology company, Cogstate, Ltd. The collaboration enables ERT to expand its industry-leading 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 patient 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.”

Click here for more information and to register for the upcoming webinar, “A Better Way to Measure Cognitive Safety and Tolerability.”

About ERT
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 2019, 75% of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs, and CROs have relied on ERT solutions across 15,000 studies, spanning more than four 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.

For more information, go to ert.com or follow us on LinkedIn and Twitter.

About Cogstate
Cogstate Ltd (ASX:CGS) is the neuroscience technology company optimizing brain health assessments to advance the development of new medicines and to enable earlier clinical insights in healthcare. Cogstate technologies provide rapid, reliable and highly sensitive computerized cognitive tests across a growing list of domains and support electronic clinical outcome assessment (eCOA) solutions to replace costly and error-prone paper assessments with real-time data capture. The company’s clinical trials solutions include quality assurance services for study endpoints that combine innovative operational approaches, advanced analytics and scientific consulting. For 20 years, Cogstate has proudly supported the leading-edge research needs of biopharmaceutical companies and academic institutions and the clinical care needs of physicians and patients around the world. For more information, go to cogstate.com.

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Christine Tobin
ERT
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