Total Consent

Medable Total Consent is a complete eConsent management solution designed to simplify and accelerate patient enrollment in clinical trials. Built for sponsors, CROs, and research sites, it enables compliant, engaging informed consent experiences for participants anywhere in the world — whether in-clinic or fully remote — across more than 60 countries and 115+ languages.

Going beyond standard eConsent tools, Total Consent combines flexible signature collection, integrated TeleVisit capabilities, real-time monitoring, and self-service authoring into a single unified platform. It is designed to comply with all major global regulations, including FDA 21 CFR Part 11, ICH E6 (R2), and GDPR, making it suitable for any country conducting clinical research.

Expanding Global Access to Trials

• Accessible on any web-enabled device, supporting both bring-your-own-device (BYOD) and provisioned device models
• Scalable solution capable of informing and consenting participants anywhere in the world
• Flexible enough to accommodate any country or site requirements
• Supports both digital and wet-ink signature collection for maximum geographic compatibility
• Integrated TeleVisit functionality enables fully remote consent without requiring additional tools or separate login credentials

Improving Participant Retention and Engagement

• Real-time notifications help ensure participant compliance throughout the trial
• Patient and caregiver-friendly ePROs (electronic Patient-Reported Outcomes) make it easy to track toxicity and tolerability in real time
• Supports diverse learning styles through multimedia-enriched, interactive consent experiences as defined by Transcelerate
• Keeps sponsors connected with patients and their data throughout the study lifecycle

Minimizing Compliance Errors and Ensuring Oversight

• Single dashboard provides complete visibility and real-time monitoring of all consent activities
• Fully integrated template management and version control ensure inspection-ready audit trails
• Permission-based workflows organized by roles and responsibilities for secure, controlled access
• Designed to meet all global regulatory requirements, including FDA 21 CFR Part 11, ICH E6 (R2), and GDPR

Key Features of Total Consent

• Self-service authoring tool for easily creating engaging, customized consent templates
• Biosample attribution functionality to confirm storage permissions for consent objects
• Scalable across trials of all sizes, from single studies to large multi-study deployments
• Standardized delivery methods that increase organizational efficiency the more the platform is used
• Supports 115+ languages across 60+ countries and locales
• Can be used in-clinic, at home, or anywhere a participant has an internet connection

Proven Real-World Results

• ICON and Medable achieved 85% eConsent adoption across 1,200+ participants in a complex U.S. women's health menopause study using a site-first approach
• Medable's platform has demonstrated a 97% patient retention rate in a decade-long global long-term follow-up (LTFU) obesity study without relying on a traditional EDC system

Total Consent integrates seamlessly within the broader Medable clinical trial platform, which also includes eCOA and ePRO solutions for oncology and other therapeutic areas. Its compliance-first architecture, multi-language support, and built-in TeleVisit capabilities make it a comprehensive choice for organizations seeking to modernize and globalize their consent management processes.