Adjudicate

Endpoint review often breaks down as handoffs increase and more reviewers get involved.

Medidata Adjudicate brings that work into one place, so your teams keep decisions consistent without slowing review timelines.

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Ensure Every Endpoint Decision is Traceable

As endpoint volume increases, applying decisions consistently becomes harder—especially when more reviewers and committees are involved. Delays and rework often follow when review processes aren’t built to scale.

Adjudicate gives teams a structured way to manage endpoint review, helping decisions remain consistent and traceable, with the confidence needed for regulatory scrutiny.

Keep Endpoint Decisions Consistent

Track Event
Status in One Place

Minimize Review
Delays and Rework

Support Predictable
Review Timelines

Reduce Duplicate Entry
with EDC Integration

Where Adjudicate Makes a Difference

Structured Review

Standardize Endpoint Review

Adjudicate provides a structured way to manage endpoint review, from event intake and de-identification to dossier assembly and committee decision-making.

Teams apply endpoint definitions consistently, without relying on manual coordination or disconnected tools.

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Medidata Adjudicate Demo

See how Adjudicate supports structured endpoint review, event tracking, and committee decision-making in a single system.

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Video transcript: In today's event driven trials, how the adjudication process is managed can have a major impact on your trial's success. Adjudication is the process by which an independent blinded expert committee reviews clinical events that occur during the trial. These clinical event committees or CEC and adjudication steps are often managed using outdated, disconnected manual processes or using technology that is siloed and often lacks the necessary visibility into the status of events and proper document control. The impact of these challenges is high and can result in long implementation times and compliance risk. When a high quality systematic and standardized CEC process is incorporated into your clinical trial, it will enhance not only the validity but also the speed of your trial results. However, a strong technology solution and endpoint adjudication system is critical to transform your process in a compliant manner. Metadata Adjudicate is a cloud based end to end platform designed with easily configurable modules that enable quick setup to manage all endpoint adjudication in clinical trials. Adjudicate is designed to support investigator sites, CROs, data managers, the CEC, and sponsors who collect, manage, organize, adjudicate, and submit clinical endpoint data. An efficient CEC process is critical to reduce variability in adjudication outcomes and to ensure the best outcomes are collected for your trial. Having the right endpoint adjudication technology allows you to trace every aspect of the event from collection, de identification, and dossier aggregation to committee review and management, giving you control and visibility of all your events. When using Metadata Adjudicate, you immediately gain intelligent flexible workflows that optimize tasks while ensuring data quality. Easy to use navigation tools for CECs with real time visibility for all tasks and statuses. Self-service configuration putting control in your hands for quicker study implementation. A single unified platform for all your trial needs. Part of the proven scalable metadata clinical cloud. Optimize your adjudication with a solution that enables faster implementation and seamlessly and securely support any type of committee design. Gain visibility and control over your clinical trials endpoint adjudication with metadata adjudicate.

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FAQ

How does Medidata Adjudicate integrate with Rave?

Medidata Adjudicate is fully unified with the Medidata Platform, allowing for automatic subject creation and direct unification with Rave. This integration reduces duplicate data entry and administrative workload by providing real-time visibility into events and statuses across the trial.

Does the platform include tools for document management and PHI redaction?

Yes. The solution includes a built-in web-based PDF editor that supports the creation of dossiers, including labeling, bookmarking, and organization of elements. It also features built-in PHI redaction tools with search-and-redact capabilities to ensure compliant and efficient document management.

Can Medidata Adjudicate support different committee review models?

Yes. The system offers flexible workflows designed to support various committee structures, such as double review with adjudication, triple review, and consensus models. It includes automated triggers for committee member discordance and side-by-side form comparisons to facilitate easy consensus review.

What types of data can sites upload for adjudication?

Sites can easily upload any clinical trial data type, including standard documents and medical images, directly into the platform. The cloud-based system requires no software installation and utilizes single sign-on to reduce the time and effort required from site staff.

Does Medidata offer training for its clients and partners?

Yes. Medidata offers a variety of training options for our clients and partners, including both self-paced and instructor-led courses. To learn more about available courses and to access our resources, please visit the Medidata Global Education and Training section.

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