Designer

Study build tools have improved, but trial timelines are still under pressure. The real delays don’t happen during initial setup. They show up later, when protocol changes trigger reviews, rework, and uncertainty across the study.

Medidata Designer is a study build solution designed to keep protocol intent, study configuration, and downstream execution connected as change happens.

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Video transcript: MayData Designer is a central space for all stakeholders in the study build process to come together and collaborate. With real time dashboards, data managers can have visibility into the progress of the study build, as well as transparency into how many study objects have been approved and are ready for production. For a data manager, review and approval of study objects no longer has to take place in cumbersome UAT trackers and issue logs. With Medidata Designer, the review and approval can take place alongside the study configuration with automated versioning and documentation, making it quick and easy to see which objects are ready to be pushed to production. Collaboration with the study builder now takes place alongside the study objects, making it easier and more transparent as to which forms or fields may need updating in addition to who and when these comments are raised. This ensures mid study changes can be implemented with transparency and efficiency to reduce study build timelines. Edit check user requirements can be bulk entered with just one click directly into designer, capturing the user requirements alongside the edit check logic and eliminating the need for external systems and processes to manage these user requirements. This also makes it easier for study teams to manage, review, and approve edit checks. And this is why Medidata is making one click study builds possible.

Design Studies to Keep Up with Change

Built to go beyond initial setup, Designer connects protocol intent to study configuration so updates are defined once and managed consistently as studies evolve.

By centralizing how changes are handled, teams reduce rework, maintain alignment, and keep studies moving from start-up through closeout.

Protocol-aligned Builds
Centralized Study Updates
Reduced Downstream Rework
Clear Version Traceability

Stay in Control as Studies Evolve

Built for Change

Keep Studies Aligned as Protocols Evolve

Designer manages study configuration as a single source of truth. When protocols change, updates are applied once instead of rebuilt across forms and systems.

This helps teams manage amendments without fragmenting study structure.

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FAQ

The platform utilizes AI-powered automation and a protocol-first approach to address delays throughout the build lifecycle, from protocol intake to validation. 

Yes. Medidata Designer creates a single source of truth for the study build across multiple trial capabilities. Beyond Rave, it is used to build patient experiences for Medidata eCOA (including complex instruments and CNS trials) and configure sensor studies using low-code/no-code tools.

Yes. The platform is built with automation and reuse at its core, enabling teams to "build once and deploy everywhere." It features global libraries that allow sponsors to store and reuse standardized instrument builds, forms, and translations, which ensures consistency across systems and reduces the time spent on future builds.

Medidata Designer uses AI to handle the "heavy lifting" of study setup, such as instantly translating study plans into digital case report forms (eCRFs) and providing intelligent suggestions. It automates high-volume, low-complexity tasks—like generating study objects and edit check logic—while keeping a "human-in-the-loop" to apply real-world expertise.

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.