MedAvante Surpasses 630,000 Electronic Source (eSource) Clinical Trial Assessments

Extends Leadership Position in Electronic Clinical Outcome Assessments (eCOA)

Hamilton, NJ (November 15, 2016) — MedAvante, Inc., the leader in technology-based clinical trial services for central nervous system (CNS) diseases, announced significant advances in the deployment of the groundbreaking Virgil® Investigative Study Platform for global clinical trials as the source (eSource) data platform begins its third year in worldwide use.

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“MedAvante pioneered eSource data capture in 2009 for use by our own clinicians, developed by our own technology experts,” said MedAvante CEO Paul Gilbert. “We have more eSource experience than anyone else – 630,000 assessments of 50,000 clinical trial subjects across 220,000 study visits – and our eSource data has been accepted by both the FDA and the EMA in successful regulatory submissions.”

With this experience, and continuous improvements based on input from rating scale experts as well as MedAvante clinicians using the platform, just over two years ago the company began offering the Virgil platform for use by site-based clinicians.

“The Virgil platform, which hosts all forms of electronic outcome assessments (eCOA) including clinician-reported and patient-reported (PRO) instruments, is leading the way for clinical trials crossing the digital divide,” said Gilbert.

To date, the Virgil platform has been deployed at more than 900 clinical trial sites in 30 countries and is currently collecting eSource data for more than 20 major clinical studies. The tablet device-based Virgil site application has been used to administer more than 45,000 site-based assessments to nearly 12,000 subjects at more than 19,400 clinical trial visits.

“Being ready at so many sites in so many countries around the world means faster startup time for the sponsors who’ve come to rely on us,” said Gilbert. “Sponsors know that Principal Investigators, study coordinators and site raters are already familiar with the platform. This makes a huge difference in the time needed to get a trial up and running.”

The Virgil platform has also achieved rapid growth by being user-friendly. “One formerly skeptical clinician told us that when he used Virgil for the first time to administer a particularly complex rating scale, he felt it was the best assessment he’d ever conducted,” said MedAvante president and co-founder Amy Ellis.

“He told us Virgil was simpler to use than paper, and more importantly it allowed him to concentrate on the subject more fully than he had ever been able to before,” said Ellis.

Compared with paper and pen, the Virgil platform reduces administration and scoring errors. Analysis of error rates across four widely used rating scales in actual Alzheimer’s disease clinical trials found that errors were reduced by approximately 50 percent to over 80 percent versus paper and pen.

In addition to ease-of-use and improved data quality, Virgil seamlessly integrates all scale-related activities to alleviate the burden on site staff, and delivers data analytics for monitoring rater and site performance, all on a single platform.

“The increasing use of eSource in clinical trials today can be accurately compared to the growth of digital technology that started two decades ago in financial services,” said Ellis. “Can you imagine suggesting to people today that they should do their trading or banking on paper? We believe the same level of universal trust is coming to clinical research with regard to everyday capture of essential information – and the robust security and reliability of our Virgil platform is hastening the trend.”

MedAvante marked the Virgil platform’s second anniversary with one more milestone: accumulation of eSource data equivalent to 3.65 million sheets of paper – which if stacked would tower over the Empire State Building – without losing a single data point.