eConsent

Suvoda eConsent is an electronic informed consent solution for clinical trials, designed to improve patient comprehension of study information and give sponsors full visibility and automated control over the consent and reconsent process. It is built for study teams, site professionals, and sponsors managing complex trials—particularly in oncology, rare disease, and CNS, where protocol amendments and reconsent requirements are common.

Informed consent in modern clinical trials is not a one-time event. The majority of protocol amendments require patients to re-consent, which introduces regulatory risk, administrative burden, and added study duration and cost. Suvoda notes that approximately 70% of the oncology studies it supports have at least one protocol amendment, and trials with three or more amendments add an average of three weeks to planned treatment duration. eConsent addresses these challenges by automating consent tracking and integrating directly with Suvoda's IRT (Interactive Response Technology) platform.

Patient Comprehension Features

• Embedded videos and FAQs to help patients understand complex medical and legal content
• In-document discussion threads allowing patients to raise questions within the consent form
• Cross-linked glossary to clarify terminology encountered during the consent process

Flexible Consent Design

• Supports electronic signature, wet ink upload, or print-and-sign consent options
• Accommodates multiple consent types, including subject, caregiver, and legally authorized representative
• Supports multiple, separately timestamped signatures from a single participant within one consent form
• Multilingual capability to support international trials
• Available on multiple devices, including web-based access, on-site terminals, or patient-owned devices

Platform Architecture and IRT Integration

• eConsent is built on the same single clinical trial technology platform as Suvoda IRT, appearing as additional functionality within the IRT system rather than a separate application
• Data is shared between eConsent and IRT without requiring users to log into a separate system
• When a site user initiates a study visit, IRT automatically checks whether the patient has consented to the latest version of the consent form
• If consent is not current, a prompt within IRT requires completion of the consent forms before the visit can proceed
• Approved consent documents are uploaded by Suvoda and managed within the integrated environment

User Interface

• eConsent shares the same minimalist, intuitive interface as Suvoda IRT, reducing the need for significant additional user training
• Site and study professionals can move between randomization and trial supply management (RTSM) activities and eConsent tasks within the same digital environment
• The consistent interface is intended to make the consent process more accessible for patients as well as site staff

Reporting and Compliance

• Real-time visibility into consent status for all subjects across all study sites, accessible within the Suvoda IRT reporting tools
• Identifies sites that are lagging in obtaining patient consent to the latest form versions
• Digital archiving of consent documents for compliance and audit purposes
• Study teams and field monitors can verify consents were completed correctly without requiring physical site visits
• Early corrective action can be taken with outlier sites based on real-time reporting data
• Aims to reduce the risk of patient exclusion and discarded data at trial conclusion due to consent non-compliance

Suvoda eConsent is part of a unified clinical trial platform that also includes IRT/RTSM and eCOA capabilities. The platform has been used in over 900 trials across 65 countries, with 75% of trials in oncology, rare disease, and CNS indications. The integrated architecture is intended to reduce technology fragmentation and support regulatory compliance across complex, multi-site global studies.