eConsent

Jeeva eConsent is a SaaS-based electronic informed consent platform designed for clinical researchers running decentralized, hybrid, or in-person clinical trials. It supports remote and in-person eSignatures, video-based consent delivery, and enterprise-wide deployment across single or multiple study sites. The platform is hosted on AWS and is built to address the time, cost, logistical, and comprehension challenges associated with traditional paper-based informed consent processes.

The platform operates as an eConsent as a Service (eCaaS) model, enabling research teams to manage all eConsent and eAssent forms within a central module. Investigators can create, rename, edit, publish, assign, unpublish, or delete consent forms, and view details including participant assignments, version numbers, status, IRB approval and expiration dates, and applicable sites.

Problems the Platform Addresses

• Research investigators typically spend 15–60 minutes per subject obtaining informed consent, a highly repetitive process that consumes significant staff time.
• Patients are often expected to read and understand approximately 50 pages of information within a single 15-minute consultation, leading to information overload.
• In-person consent involves direct and indirect costs including investigator time, coordinators, nurses, and facility use.
• Patients, caregivers, and legally authorized representatives (LARs) frequently must travel to investigation sites and wait extended periods to complete consent.
• Investigators are required to verify that patients fully understand trial risks and benefits before consent is obtained.
• Traditional tools lack flexibility to support the range of in-person, remote, and hybrid consent scenarios required by modern multi-site trials.

Key Advantages

• Reported 90% reduction in researcher time spent on the consent process, allowing patients to review trial information at their own pace from home.
• Multimedia content delivery reduces information overload; patients can access and revisit all trial information at an online portal before and after signing.
• Reported 90% cost savings through a software subscription model that maintains compliance and consent integrity.
• Eliminates the need to repeat information to each patient individually by using video and multimedia formats accessible on patients' own devices and schedules.
• Comprehension is verified through quizzes or scored questionnaires, and FAQs are available to support informed decision-making.
• Supports fully remote, entirely in-person, or hybrid consent workflows depending on participant preference, IRB requirements, or investigator comfort.

Flexible Consent Scenarios Supported

• Entirely in-person and paper-based consent that is subsequently scanned to electronic (PDF) format for archival and remote verification.
• In-person electronic informed consent with eSignature collected on an iPad at an investigator site during a patient visit.
• Fully remote electronic informed consent conducted via live interactive video call, with calls and eSignatures from the patient, investigator, and LAR recorded.
• Support for Central IRB or site-specific IRBs to review the eConsent experience as it appears to patients prior to approval for use.

Platform Features

• Secure and compliant platform configurable for multiple regulatory environments.
• Legally binding electronic signatures for patients, customers, and other stakeholders.
• Configurable for multiple languages, with localized content, controlled translations, and approval workflows.
• Accessible from various hardware devices across different screen sizes.
• Tamper-evident electronic signatures with date/time stamps, audit trails, and documented reasons for signature changes, meeting FDA 21 CFR Part 11 requirements.
• Automated prompts for re-consent when updated consent versions are released, with detailed delta reports tracking all changes.
• HIPAA authorization forms and country-specific privacy notices can be integrated directly into the consent flow.
• Remote consent workflows include secure identity verification and options for witness and LAR participation.
• Social media outreach capabilities to targeted participant groups to support recruitment.
• Customizable and configurable to fit study-specific requirements.

Compliance and Regulatory Support

• Supports FDA 21 CFR Part 11 electronic signature requirements.
• Integrates HIPAA authorization and country-specific privacy notices into the consent workflow.
• Supports Central IRB and site-specific IRB review processes.
• Maintains version control with automated re-consent workflows and full audit trails.

Jeeva eConsent is designed to be disease-agnostic and device-agnostic, supporting decentralized and hybrid trial operations across single studies or enterprise-wide deployments. The platform is hosted on AWS and is described as modular and flexible to accommodate varying protocol complexity and regulatory requirements across national and global sites.