MedAvante VIRGIL™ Investigative Study Platform Adopted by Drug Developers

 

Oct 01, 2014
Global Clinical Trials Get Breakthrough Technology to Improve Signal Detection

Hamilton, NJ – MedAvante, Inc., the world’s leading provider of technology-enabled signal detection solutions in clinical trials of treatments for central nervous system (CNS) disorders, announced the deployment of its groundbreaking Virgil Investigative Study Platform in multiple clinical trials worldwide.

The Virgil platform, developed specifically for investigative sites, was pioneered by MedAvante to standardize scale-based outcome measurements, making administration easier and scoring of sensitive data points more consistent and accurate.

Virgil is based on MedAvante’s unique history with six years of clinician experience administering more than 150,000 assessments in large global studies using MedAvante’s proprietary electronic source tablet technology and electronically capturing source data that has been accepted by both the FDA and the EMA in successful regulatory submissions.

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. Virgil tablet computers, programmed with MedAvante’s administration and scoring guidance as well as built-in quality checks to identify errors or omissions, help to standardize every assessment by every clinician at every site.

After each assessment, Virgil automatically uploads electronic source documents and recordings to a secure central data hub, which routes them to a dedicated web portal where sites, CROs and study teams can view, track and manage all data. Selected visits can be seamlessly handed off to MedAvante’s clinical over-read service, Central Review, for additional quality assurance.

“We are very excited by the highly enthusiastic response to Virgil,” said MedAvante President Amy Ellis. “When we describe how we are combining digital technology with clinical guidance to standardize ratings and reduce variability, everyone we talk with immediately recognizes the positive impact on signal detection and the streamlining of workflow at the site.”

The Virgil platform, developed by clinicians for clinicians with input from MedAvante’s advisory network of leading Principal Investigators, is based on intuitively interactive electronic rating scale forms that simplify the clinician’s job of administering and scoring what are often complicated paper instruments.

“Intuitive form design not only makes Virgil better than paper worksheets, it is far superior to simply transferring printed pages to an electronic format. That’s where MedAvante’s clinical experience really makes a difference,” said Ellis. “Because Virgil offers clinical guidance in the form of ‘just-in-time’ prompts and reminders, clinicians no longer need to memorize specific scoring anchors and rating guidelines they may have trained on months earlier.”

Virgil’s unique clinical and operational capabilities optimize quality and efficiency with a high degree of user-friendliness. Sites are also freed from 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.

“CNS clinical trials disproportionately fail to establish conclusive proof of treatment efficacy,” said Ellis. “Now the Virgil platform can tie together procedures and systems that because they were previously disconnected introduced additional ‘noise’ into study results. With Virgil’s guidance, signal detection improves and site burden is minimized.”

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.