Virgil

Leading the revolution in clinical trials.
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The Virgil Investigative Study Platform

Virgil, MedAvante’s eSource platform, provides digital clinical outcome assessments (eCOA) and data management for clinical trials. From entry to upload, it’s a seamless process that maximizes the potential of your data while minimizing the possibility of error. Virgil is built to ensure your trial data is secure, accurate and complete.

What makes Virgil different?

Virgil incorporates clinical guidance for each assessment scale to ensure results are standardized across raters. Because Virgil was designed by clinicians for clinicians, our platform puts MedAvante’s years of experience in capturing and managing study data for global trials into the hands of sites and sponsors.

In 2009, MedAvante pioneered the development of electronic assessments to provide first-to-market eCOA through our Virgil Platform.

Today, we’re leading the way to the eSource revolution.

Delivered on web-based and tablet devices, the Virgil Platform includes:

  • A site application to manage subject visits, administer and score rating scale instruments.
  • A web-based portal to review high-level data from sites.
  • An app for patient-reported outcomes (PROs).

The Virgil platform has been used for hundreds of thousands of patient assessments in clinical trials around the world. Our source data is reliable and has been accepted by the FDA and EMA in successful drug applications.

Virgil also enables the integrated delivery of MedAvante’s clinical services. In combination with our services, Virgil can enhance signal detection for all types of studies.

What is eSource?

“eSource” encompasses all electronic source data – outcome assessments, forms (including medical history, concomitant meds, etc.), and lab data. Clinical outcome assessments (eCOA) can be further categorized into clinician-reported, patient-reported and observer-reported outcomes (ClinRO, ePRO and ObsRO).

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One platform, many capabilities.

Virgil brings the power of smart data to your study.

Virgil Clinician-Reported Outcomes (ClinRO)

Virgil’s ClinRO is grounded in MedAvante’s years of experience as clinicians. We devised our eSource solution to streamline workflow and logistics for our own clinical teams. Our unique clinical heritage continues to drive all of our advances in eSource.

Our intuitive Virgil tablets help standardize clinician-reported outcomes with built-in clinical guidance. Virgil uses standardized measurements to guide a rater performing or scoring an assessment. This leads to better signal detection for your study.

Virgil is completely paperless. Removing binders, clipboards and piles of paper, Virgil simplifies the process and enables better interaction with patients during clinician assessments.

Virgil makes capture, upload and analysis easy. Virgil ensures fewer errors and discrepancies with built-in checks and reminders. Virgil also improves site workflow by flagging incomplete data entry, performing autoscoring and capturing video and audio recording.

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F7K9E8 Doctor with digital tablet talking to pregnant patient in clinic corridor. Image shot 2015. Exact date unknown.
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Virgil Electronic Patient-Reported Outcomes (ePRO)

Virgil’s ePRO benefits both patients and sponsors by accelerating the timeline and lowering the development costs of a study. Integrated with the rest of the Virgil platform, it offers a holistic view of trial progress and patient experience. MedAvante can deliver ePRO on preconfigured hardware or as a simple download onto patient’s own devices.

ePRO can help clinicians capture better data. Virgil ePRO enables real-time responses and eases the process of patient data capture and submission. It also makes it possible for patients who can’t get to a study site to participate, improving trial efficiency and reducing the risk of patient attrition.

ePRO can improve patient engagement and adherence to study protocol. Virgil’s ePRO app for mobile devices allows patients to take quick assessments on their smartphones – and be reminded if they’ve missed one. Customizable alerts can also remind patients about medications. ePRO makes it possible for patients to fit study requirements into their daily lives.

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Virgil Observer Reported Outcomes (ObsRO)

Observers are key components of many clinical trials. Virgil’s ObsRO assessments let family and caregivers offer insights as a trial progresses.

Like our other outcome measures, Virgil’s ObsRO can be customized for the study’s patients, sites and sponsors.

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Problem:

50

Rate of increase in failed Phase II and III clinical trials, 1990-2010.

66

Rate of failure due to an inability to show efficacy.

Solution:

Stronger signal detection through Virgil.

Virgil Portal

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The Virgil platform includes a secure, web-based portal that allows for remote review, monitoring and analysis of your study’s data. The data collected on Virgil tablets is uploaded to the Virgil portal, enabling timely insights and high-quality analytics. Comprising the analytics: data whose reliability rests on the expert guidance that reflects our heritage of clinical experience and innovation.

The Virgil portal allows real-time analysis of a study’s data and progress. Search by preferred criteria to find results fast. Compare results and gain insights into your study as it progresses.

The Virgil portal also greatly reduces the number of onsite monitoring visits, since records can be accessed and reviewed from anywhere.

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