Genius vENGAGE: The Remote Verbal Consent for a Patient-Centric Clinical Trial
Exom Group, a Clinscience company, is proud to announce the release of the first patient-centric “reliable & compliant” remote verbal consent for clinical trials (Genius vENGAGE). The solution facilitates the patient’s participation in clinical trials even when logistical, geographical, or time difficulties make participation impossible.
Genius vENGAGE Remote Verbal Consent enables the investigator to share with the patient via smartphone the written consent form and the verbal explanation of the study and to collect the “verbal consent” if the patient agrees to participate in the trial.
The verbal approach made the remote consent procedure very fast, adaptable to any kind of consent content, and easy to use regardless of the involved subjects’ age, cultural standards, and education.
For each study, a customized and automated audio-text interaction in all needed languages is generated.
The patient can autonomously decide when to start the consent procedure, which, at any time, can interrupt. Suspend or request a direct call with the investigator to raise questions.
After the investigator’s electronic signature, the entire recorded remote audio consent procedure is transcribed into a final PDF document delivered to both patient and investigator.
Genius vENGAGE remote verbal consent is available as a stand-alone application or integrated into Genius eTMF for the automated upload of site-specific consent forms and languages and Genius EDC to generate the eCRF patient code when the consent process has been completed with the investigator’s signature.
Genius vENGAGE Remote Verbal Consent is fully compliant with regulations on data privacy (GDPR) and computer system validation in clinical trials (21 CFR part 11).
You might also be interested in learning about our other Genius SUITE solutions and how Exom can support your clinical trial program.