ClinOne’s eConsent for Sites: Advantages and Significant Savings
Our eConsent is a technology critical to clinical trial stakeholders and will eliminate any violations related to Information Assurance and Privacy (ICF) compliance while eliminating hundreds of work hours for sites.
- Improved workflow for patient consent: ClinOne has mastered the ideal workflow for the consenting process for patient and site coordinators. The technology uses our e-signature partner’s electronic signature platform, where the PI and patient can both sign remotely from mobile devices. It can then be posted to the site’s EFC of choice.
- Remote consenting: ClinOne allows patients to remotely consent in non-critical studies/procedures, ideal for those homebound. When consenting a patient, the app uses our embedded FDA-compliant remote consenting feature, enabling a patient, caregiver or co-parent to complete ICFs remotely or across multiple research sites. Documents are instantly viewable by all relevant parties: site, patient, and sponsor.
- Real-time compliance tracking for re-consents: The eConsent technology tracks ICF versions and recognizes active patients that require re-consents, notifying the PI, coordinator and the patient. Our eConsent system provides weekly auto-generated reports of completed consents, and flags issues immediately, keeping everyone consistently updated.
- Automated consent logs: Sites can access automatically-generated consent notes and logs, keeping in compliance with mandated FDA regulations. The final PDF of the consent is created and attached to the completed ICF, ready for inspection.
ClinOne’s eConsent process contributes to improving studies and keeping sites in compliance for the entire length of their trials. Please contact us for more information or to receive a demo.