Florence eConsent

Florence eConsent is an eConsent platform provided by Florence Healthcare. The platform aims to digitize, automate, and integrate the informed consent process in clinical research, ensuring convenience, security, and compliance for participants, site staff, Institutional Review Boards (IRBs), sponsors, and Contract Research Organizations (CROs).

Key Features

Intuitive Site Workflows: Florence's eConsent platform replicates the familiar appearance and flow of paper-based informed consent, facilitating a seamless transition to digital for participants, site staff, IRBs, and sponsors.

Proven IRB and Sponsor Approval: Florence's eConsent has received approval from major sponsors, CROs, and IRBs. The platform has been successfully implemented and is operational at leading academic centers and nationwide health systems.

Easy-to-use Participant Interface: Participants can easily navigate and sign their informed consent forms from any device, anywhere. The platform supports multiple studies and provides a single login and interface for all active studies. Mobile device compatibility enhances participant engagement.

Compliant and Secure: Florence's eConsent includes compliance features such as signature verification, automated audit trails, version control, and user permission options. The platform supports the development of standard operating procedures (SOPs) and ensures adherence to regulatory requirements while safeguarding participant information.

Deploy eConsent Across Sites: Sponsors and CROs can effortlessly deploy eConsent across their network of sites for any study. Integration with the SiteLink platform offers continuous visibility into consent processes, enabling effective study management and oversight.

Always Up-to-date Versions: Easy version controls and IRB routing workflows ensure participants are always consenting to the most recent version of the informed consent. This prevents the use of outdated consent forms, ensuring compliance and accuracy.

Intuitive Participant Management: The platform provides user-friendly workflows for quick study setup and activation. Participants can be easily invited into the eConsent platform with minimal effort. Real-time monitoring of participants' informed consent status facilitates efficient management and tracking. Remote participant identity verification adds convenience and flexibility.

Global Study Management: Consent workflows can be easily set up and managed in a user-friendly environment designed for speed and compliance. Study staff can be invited, assigned, and managed with pre-defined permissions, ensuring seamless collaboration and adherence to roles and responsibilities. Audit trails and version control tracking maintain compliance and provide a clear record of consent-related activities. The platform establishes repeatable and scalable processes for future studies.

Familiar Consent Creation: Florence's eConsent allows for a smooth transition from paper consent to electronic consent by enabling the upload of familiar document-style forms. It eliminates the need for digital media and content creation staff, ensuring the use of up-to-date versions. eSignature workflows comply with Part-11 regulations, providing a legally valid consent process.