Designer

Medidata Designer is a central study build hub designed to keep protocol intent, study configuration, and downstream execution connected throughout the life of a clinical trial. Rather than focusing solely on initial setup, Designer addresses the real source of delays — protocol amendments and changes that trigger reviews, rework, and misalignment across study systems. It is built for clinical operations teams, sponsors, and study builders who need to manage evolving studies with consistency and control from start-up through closeout.

By centralizing how changes are defined and applied, Designer acts as a single source of truth for study configuration. Updates are made once and propagated consistently, reducing fragmentation and keeping teams aligned as protocols evolve. The platform supports builds across multiple Medidata capabilities, including Rave EDC, Medidata eCOA, and sensor-based studies.

Core Capabilities

• Protocol-aligned builds: Study configuration is directly tied to protocol intent, ensuring that the study structure reflects the protocol from the outset and remains aligned as amendments occur.
• Centralized study updates: When protocols change, updates are applied once rather than rebuilt across individual forms and systems, preventing fragmentation of study structure.
• Reduced downstream rework: By managing changes through a single source of truth, teams avoid the cascading rework that typically follows protocol amendments.
• Clear version traceability: The platform maintains visibility into how the study configuration has evolved, supporting audit readiness and change management.

AI-Powered Study Build

• Designer uses AI to handle high-volume, low-complexity tasks such as instantly translating study plans into digital case report forms (eCRFs) and generating study objects and edit check logic.
• Intelligent suggestions are provided throughout the configuration process to accelerate setup and reduce manual effort.
• A human-in-the-loop approach is maintained, ensuring that real-world expertise is applied alongside AI automation rather than replaced by it.
• The platform is designed to move teams from protocol intake through validation faster by removing friction at each stage of the build lifecycle.

Reuse and Standardization

• Designer is built with a build once, deploy everywhere philosophy, enabling teams to reuse study components and forms across different trials.
• Global libraries allow sponsors to store and reuse standardized instrument builds, forms, and translations, ensuring consistency across systems.
• Reuse of validated components reduces the time and effort required for future study builds.

Supported Study Types and Products

• Beyond Rave EDC, Designer supports the build of patient experiences for Medidata eCOA, including complex instruments and CNS trials.
• Sensor-based studies can be configured using low-code and no-code tools within the platform.
• The platform is designed to serve as a unified study build hub across multiple trial capabilities within the Medidata ecosystem.

Change Impact Management

• Designer is specifically engineered to handle the downstream consequences of protocol changes, helping teams understand and manage the impact of amendments before they cause delays.
• Validation at scale is supported, allowing teams to confirm study configuration integrity as changes are introduced throughout the trial lifecycle.

Medidata Designer integrates within the broader Medidata Platform, connecting to the Data, Study, and Patient experiences as well as Professional Services. Training is available for clients and partners through Medidata Global Education and Training, with both self-paced and instructor-led course options to support adoption and proficiency.