Medable Total Consent offers a comprehensive eConsent solution designed to simplify and accelerate clinical trials while enhancing participant experience and ensuring regulatory compliance. This scalable platform enables global access to trials, allowing participants to be informed and consented anywhere in the world on any web-enabled device. It supports flexible signature collection, including digital and wet-ink, both on-site and remotely with integrated TeleVisit capabilities. The solution significantly improves participant retention through real-time notifications and patient-friendly ePROs, facilitating continuous tracking of toxicity and tolerability. For sponsors, Total Consent minimizes compliance errors by providing complete visibility into all consent activities via a single dashboard, ensuring inspection-ready audit trails with integrated template management and version control. Key functionalities include a self-service authoring tool for creating engaging consent templates, biosample attribution for confirming storage permissions, and permission-based workflows for secure control. It is meticulously designed to comply with global regulations such as FDA 21 CFR Part 11, ICH E6 (R2), and GDPR, supporting over 115 languages across 60+ countries. By transforming the consent process, Total Consent reduces administrative burden, improves participant education, and lowers dropout rates, ultimately leading to more efficient, educational, and empathetic clinical research.

Features & Benefits

• Global Trial Access: Accessible on any web-enabled device, supporting digital or wet-ink signatures, on-site or remote via TeleVisit, and compliant with global regulations across 60+ countries and 115+ languages.
• Enhanced Participant Retention: Utilizes real-time notifications and patient/caregiver-friendly ePROs to track data and maintain engagement throughout the trial.
• Minimized Compliance Risks: Provides complete visibility and real-time monitoring of consent activities, ensuring inspection-ready audit trails, integrated template management, and version control.
• Self-Service Authoring & Management: Features a self-service tool for creating engaging consent templates, biosample attribution, and permission-based workflows for secure control.