Adjudicate

Medidata Adjudicate is a clinical trial endpoint adjudication system designed to bring structure, consistency, and traceability to the endpoint review process. Built for sponsors, clinical operations teams, and adjudication committees, it consolidates the full review workflow into a single platform — from event intake and de-identification through dossier assembly and final committee decision-making — eliminating the fragmentation that occurs when handoffs increase and more reviewers become involved.

As endpoint volume scales across complex trials, maintaining consistent decisions and meeting regulatory scrutiny becomes increasingly difficult without purpose-built tooling. Adjudicate addresses this by providing standardized workflows, real-time event tracking, and integrated document management, helping teams reduce delays, minimize rework, and support predictable review timelines.

Core Capabilities

• Structured endpoint review: Manages the complete review lifecycle, from event intake and de-identification to dossier assembly and committee decision-making, ensuring endpoint definitions are applied consistently without reliance on manual coordination or disconnected tools.
• Event traceability: Tracks event status in one place, giving teams full visibility into where each case stands throughout the adjudication process and ensuring every decision remains auditable and traceable for regulatory review.
• Committee-ready workflows: Supports flexible committee structures including double review with adjudication, triple review, and consensus models, with automated triggers for committee member discordance and side-by-side form comparisons to facilitate efficient consensus review.
• Built-in document management: Includes a web-based PDF editor supporting dossier creation with labeling, bookmarking, and element organization, alongside built-in PHI redaction tools with search-and-redact capabilities for compliant document handling.
• Multi-format data upload: Sites can upload any clinical trial data type, including standard documents and medical images, directly into the platform without requiring software installation.

Integration and Platform Unification

• Rave EDC integration: Adjudicate is fully unified with the Medidata Platform, enabling automatic subject creation and direct integration with Rave EDC, reducing duplicate data entry and administrative workload.
• Real-time visibility: The integration provides real-time visibility into events and statuses across the trial, keeping all stakeholders aligned without manual reconciliation.
• Single sign-on access: The cloud-based system utilizes single sign-on to reduce the time and effort required from site staff, with no local software installation needed.

Key Operational Benefits

• Keeps endpoint decisions consistent across reviewers and committees at scale.
• Minimizes review delays and rework through structured, automated workflows.
• Supports predictable review timelines by reducing reliance on manual coordination.
• Reduces duplicate data entry through deep EDC integration.
• Maintains audit-ready records to support regulatory scrutiny.

Medidata Adjudicate is deployed as a cloud-based solution requiring no software installation, and is part of the broader Medidata Platform ecosystem. Medidata also provides training support for clients and partners through self-paced and instructor-led courses available via the Medidata Global Education and Training program.