MedAvante Presents Research On Electronic Clinical Outcome Assessments
Virgil eCOA Platform Reduces Errors More Than 50%
Athens Greece (March 9, 2016) – MedAvante, Inc., the leading global scientific clinical data services company today presented new research at the 14th International Athens/Springfield Symposium on Advances in Alzheimer Therapy. The new study is the first examination of actual clinical trial outcomes to determine the extent of error reduction with a digital solution such as the Virgil Investigative Study Platform, which uses a tablet device to administer and score clinical outcome assessments (eCOA) and capture source data (eSource), compared with traditional paper-and-pencil methods.
“This is a compelling demonstration of the clinical value of the Virgil eCOA platform,” said Christopher Randolph, PhD, Clinical Professor of Neurology at Loyola University Medical Center and Vice President, Neurocognition at MedAvante.
“The Virgil platform substantially reduced error rates compared to paper-based assessments across four widely used clinical rating scales,” said Randolph. “Error reductions ranged from approximately 50% to over 80% by scale, all of them highly statistically significant.”
“This is an important breakthrough for clinical trials in Alzheimer’s disease (AD) which are subject to a very high failure rate, in part due to imprecise endpoint measurements that add noise, reducing signal detection,” he said.
To demonstrate the improvement in error rates, MedAvante analyzed data sets from multinational clinical trials in Mild Cognitive Impairment (MCI) due to AD to compare traditional paper-and-pencil administered assessments with administration of the same scales using the Virgil tablet device.
“In addition to the practical advantages of eCOA administration – eliminating calculation errors, flagging missing data, eliminating EDC transfer and associated source data verification, and easing the process for central oversight – the Virgil platform has now proven the ability to significantly reduce scoring errors,” said Randolph.
A full summary of the research findings can be found here
About MedAvante, Inc.
MedAvante is the leading global provider of technology-enabled signal detection solutions in clinical trials of treatments for central nervous system (CNS) disorders with more than a decade of experience improving scale-based diagnostic and outcome measurements. MedAvante standardizes rating scale administration and scoring through two primary services: the Virgil® Investigative Study Platform for site-based assessments; and MedAvante® Central Ratings for live assessments by highly calibrated remote central clinicians. Supported by operations teams in the US, Germany, Russia and Japan, MedAvante delivers services for clinical trials in more than 40 countries worldwide. For more information, please visit www.medavante.com.
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