HAMILTON, N.J., Oct. 20, 2015 /PRNewswire/ -- MedAvante, Inc., a leading global provider of science-driven, technology-enabled signal detection solutions for studies involving clinical outcome assessments has released a major software upgrade to the groundbreaking Virgil Investigative Study Platform launched over a year ago. Virgil is now being used in large clinical trials covering various therapeutic indications with trial sites across the Americas, Eastern and Western Europe and the Asia Pacific region.
“Our Virgil platform is generations ahead with more advantages for clinical studies than any other technology solution,” said MedAvante President Amy Ellis. “Only MedAvante with more than six years of pioneering work in digital collection of clinician-reported outcome (ClinRO) assessment data in large trials of treatments for psychiatric disorders and Alzheimer’s disease (AD) could add these capabilities with the assurance that our solution remains highly reliable and operationally robust.”
“In the six years that MedAvante has been electronically capturing ClinRO data for global studies, we have collected over two million pages of source documents and never lost a single data point,” said Ellis.
Full Electronic Clinical Outcome Assessments (eCOA)
With the latest software release, clinical trial sponsors can deploy all rating scale forms to the Virgil tablet to capture a holistic view of any subject’s condition at any time during a study. Patient-reported (PRO) and observer-reported (ObsRO) outcomes are now collected in the Virgil tablet and seamlessly aligned in the Virgil web portal with the same intuitively interactive interface MedAvante developed to simplify and guide ClinRO rating instruments.
“We have listened closely to Virgil users throughout the first year to understand what works well and what could work better,” said Ellis. “One of Virgil’s key advantages is the tablet which is no more intrusive than a hand-held clipboard was designed and vetted by clinicians who told us that maintaining eye contact to build rapport with the subject is critical.”
Unobtrusive Video Recording
Virgil now adds easy-to-use video recording to the existing audio recording function, allowing users to view what the camera sees in a corner of the tablet screen next to the start, pause and stop controls. All recordings video or audio are automatically uploaded on submission by the rater and available for review in the secure, user-friendly Virgil web portal by permissioned users.
Additional Flexibility
Other enhancements in response to user suggestions include the ability to easily activate or deactivate PROs assigned to subjects, based for example on declining cognitive status, an important need in AD prevention trials. Study coordinators can also change observers during the course of a study. Assigning and preparing for assessments has been simplified for clinicians, and new options have been added for tracking subjects and visits and viewing completed assessment scores, forms and recordings.
“We will continuously strive to improve the platform in every dimension, from navigation of digital forms on the tablet device to providing smarter and smarter data in the web portal,” Ellis said.
Growing Library of Digital Rating Scales
The Virgil platform combines digital technology with clinical guidance to standardize COA ratings and ties together previously disconnected procedures and systems to minimize site burden, reduce ‘noise’ in study data and improve signal detection. Virgil is based on proprietary electronic source data technology used in tablet devices by MedAvante clinicians to administer more than 175,000 assessments in large global studies, capturing digital source data that has been accepted by both the FDA and the EMA in successful regulatory submissions.
Virgil tablets standardize COA administration and scoring with real-time clinical guidance and built-in quality checks to flag errors and prevent missing data. Virgil makes administration easier and scoring of sensitive data points more consistent and accurate with a growing library of digital implementations of the most widely-used rating scale instruments, including PANSS, RBANS, MADRS, HAM-D, CDR, ADAS-Cog and many others.
Robust operational capabilities built into the Virgil tablet and the web portal optimize quality and efficiency, sparing sites the onerous tasks of creating, handling and storing paperwork while reducing the requirements of on-site monitoring. Virgil’s highly secure web portal removes any need to find and send paper documents in responding to queries.
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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SOURCE MedAvante, Inc.
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