WCG’s ConsentNow

eConsent from the World's Most Trusted Providers of Ethics Review Services

Leveraging the patient centric approach of their Patient Engagement division, ConsentNow is the eConsent Solution that solves the problems of the traditional consent process in a regulatory compliant, patient centric collaboration tool.

 

ConsentNow is available for convenient remote consenting (via web) and also on MedAvante-ProPhase’s Virgil Investigative Study Platform eCOA tablet, easily fitting into site workflows for your studies.

The Problem with Traditional Consent

Informed consent forms, especially for complex clinical trials, often are lengthy, confusing and technical, leaving potential study volunteers wondering what involvement in the study truly means. Even if patients do end up enrolling in the study, many drop out, because the consent form was difficult to understand – 35% of those who withdrawal do so due to problems with understanding the consent (CISCRP).

This has an immense impact on study sponsors, given the costs of screening and recruiting subjects, especially if they aren’t appropriate for a study and need to be replaced.

For sites, the traditional means of consent, on paper, leads to struggles around consent process documentation, document version control, and site inspection readiness.

Read More – Engagement Shift: Informed Consent in the Digital Era

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ConsentNow™ Features

Video & Comprehension Assessments

Between video and animation segments, we programmatically deliver knowledge assessment questions to patients. We can provide these videos in multiple languages for any study; a key to providing true informed consent in a diverse population.

Consent Review & Version Control

After all videos and questions have been reviewed and answered the patient is presented with the actual Informed Consent Form (ICF) on screen for review. If the ICF changes, the videos and consent forms will be updated centrally within a web-based portal and pushed to any devices so that only the latest version is available.

Ability to Ask Questions and Get Answers

Patients can type their questions directly into the ConsentNowTM software application and review with the physician or study nurse prior to signing the consent form. The patient cannot sign the consent form until all questions are answered to their satisfaction.

Electronic Signatures

Upon completion of the ConsentNowTM process, a digital signature is obtained for the patient or guardian, the investigator, and a witness. Then it is entered and recorded in an audit trail.

Web-Based Portal / Dashboard with Analytics

Upon completion of the ConsentNowTM process, a digital signature is obtained for the patient or guardian, the investigator, and a witness. Then it is entered and recorded in an audit trail.

Secure & Regulatory Compliant

21CFR part 11, HIPAA, etc. Patient information is not stored locally on any devices. All information is stored on a dedicated server behind a secured firewall.

ConsentNow™ Enables Patient Engagement, Site Efficiencies, Regulatory Compliance

For Sponsors

  • Improved patient education
  • Reduced dropout rates
  • Consistent communication about trial
  • Site statistics
  • Regulatory compliance
  • Reduced costs for multiple studies
  • Enables risk-based monitoring

For Sites

  • Easy patient enrollment
  • Less paperwork
  • Online one-on-one site training
  • Real-time tracking of patient progress
  • IRB and ethics pre-approval
  • Consent version control, and site inspection readiness

For Patients

  • Better understanding of what the study means for them, and the benefits and risks of participation
  • Conveniently available 24/7/365 via the web or mobile device
  • Greater comprehension through the use of animation and audio visuals
  • Localized language support
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