MedAvante Introduces VIRGIL™ Investigative Study Platform
Standardizing Site Networks for CNS Clinical Trials Boosts Signal Detection
HAMILTON, N.J., May 7, 2014 /PRNewswire/ -- MedAvante, Inc., the world's leading provider of centralized assessments and quality control in clinical trials of treatments for central nervous system (CNS) disorders, announced the Virgil Investigative Study Platform for use by drug developers and their global cohort of trial sites.
For the first time, the Virgil platform puts tools built with MedAvante science and technology into the hands of clinicians at all investigative sites to standardize rating scale administration and scoring across entire trials, even entire development programs.
"We have taken successful methods and processes that distinguish MedAvante Central Ratings – such as training and calibrating our rater cohort to a uniform standard, and our pioneering system for electronic assessment scoring – and configured Virgil to provide trial sponsors with the ability to transform their best sites into their own private network of central raters," said Amy Ellis, MedAvante co-founder and president.
MedAvante has built clinical and operational capabilities into the Virgil study platform based on a decade of experience in CNS clinical trials. Virgil software ranges from intuitive electronic rating scale forms which provide clinical guidance to site raters as they administer an assessment, to highly efficient operational workflows throughout the study process. Every aspect of Virgil's design is focused on supporting site raters in optimizing assessment quality without compromising user-friendliness and site efficiency.
"CNS clinical trials disproportionately fail to establish conclusive proof of treatment efficacy," said Ellis. "Now the Virgil platform ties together previously disconnected systems and processes to improve signal detection."
Intuitive form design makes Virgil far better than paper worksheets and superior to simply transferring printed scales to electronic formats. MedAvante has been developing proprietary "smart" digital forms for more than six years and MedAvante Central Raters have used them to deliver more than 150,000 rating scale assessments for studies across the Americas, Eastern and Western Europe, Russia, South Africa and Australia.
Building on this experience, Virgil will now guide site-based raters and standardize their assessments with critical administration and scoring reminders derived from evidence of quality issues contained in extensive data and analytics collected administering Central Ratings and conducting in-study Central Review.
Seamless integration across the Virgil study platform frees sites from manually uploading documents and recordings when trial sponsors add a quality control process such as MedAvante Central Review. In addition, Virgil's highly secure web portal removes any need for sites to copy and fax documents in responding to queries.
The MedAvante Virgil Investigative Study Platform will be commercially available July 1.
About MedAvante, Inc.
MedAvante is the leading global provider of centralized expert psychiatric and neurocognition rating and monitoring services to the pharmaceutical, biotechnology and medical device industries. MedAvante Central Trial Services help sponsors enhance assay sensitivity for increased drug effect and reduce the rate of inconclusive trials, enabling them to bring better drugs to market faster. Supported by operational teams in the US, Germany, Russia and Japan, MedAvante clinicians located in 31 countries and speaking 26 languages deliver Central Trial Services in 41 countries worldwide. For more information, please visit www.medavante.com.