Medidata Consent

Medidata Consent is a modern electronic informed consent (eConsent) solution designed to accelerate trial enrollment and simplify the consent process for sponsors, sites, and patients. It supports everything from straightforward studies to complex, multi-arm pediatric trials, with flexible workflows that scale as protocols evolve — eliminating the delays, manual effort, and fragmented experiences that traditional paper-based consent introduces.

By replacing disconnected paper workflows with a connected digital approach, Medidata Consent gives sites and sponsors real-time visibility and control throughout the consent lifecycle. The platform is built to unify the patient journey from the very first step, ensuring the consent experience matches the modern, digital standards of the broader trial.

Core Capabilities

• Centralized document management: Manage all signed consent documents in one place, reducing administrative burden and minimizing transcription risks.
• Automated reminders and assessment monitoring: Send reminders to patients and monitor assessment status to keep the consent process on track.
• Pediatric assent support: Adaptive workflows accommodate age-cohort-specific requirements for pediatric assent, including clinician-led assent processes.
• Multi-arm and re-consenting workflows: Engineered to handle complex trial designs, including multi-arm studies and re-consenting scenarios as protocols change.
• Cross-site trend tracking: Track consent status and trends across sites, providing sponsors with transparent oversight as studies grow.
• Dedicated patient experience helpdesk: A dedicated support resource ensures patients receive assistance throughout the consent process.

Faster Study Start-Up

• Configure consent workflows to fit your study without custom code, enabling teams to launch trials in weeks rather than months.
• AI-assisted consent build capabilities significantly reduce the time required to configure and deploy consent forms.
• Automated version control ensures the correct forms are always in use, removing the risk of outdated documents reaching patients or sites.

Improving Patient Understanding and Engagement

• Unlike static paper forms, Medidata Consent supports multimedia content, allowing complex information to be presented in more accessible formats.
• Patients can access consent documents prior to their visit, reviewing information at their own pace and arriving better prepared for informed discussions with site staff.
• This approach fosters more empowered, research-ready participants and supports higher-quality informed consent.

Efficiency for Site Teams

• Designed with input from the Medidata Site Tech Board to reduce administrative friction and improve site productivity.
• Operates as a unified component within the broader Medidata ecosystem, integrating with Rave EDC, eCOA, and other platform tools so site staff can manage their entire study within a single streamlined environment.
• Replaces parallel paper workflows with automated, digital processes that reduce manual effort and the risk of errors.

Global and Compliance Readiness

• Supports eIDAS-compliant electronic signatures for global studies.
• Includes a hybrid paper-to-digital upload feature for regions where wet-ink signatures are still required, ensuring flexibility across geographies.
• Suitable for global deployments spanning multiple countries, IRBs/ECs, and diverse regulatory environments.

Medidata Consent is part of the broader Medidata Platform, which encompasses patient, data, and study experiences as well as professional services. Training is available for clients and partners through Medidata Global Education and Training, including both self-paced and instructor-led options.