Optimize Study Design and Improve Line of Sight
Medidata Designer® is an innovative study and protocol design solution that helps sponsors focus resources on the science of the study design, improving its quality by enabling line of sight between objectives and endpoints, structuring design components and streamlining trial execution through reuse of design information in downstream systems.
Optimize Study Design
Designer’s real-time quality check and visibility into industry benchmark and study metrics—such as procedure cost and site work effort—allow sponsors to focus the study on the most important objectives and that unnecessary procedures and data collection are eliminated in the design phase. Substantial cost savings can be realized in downstream operations—up to 20% in some cases.
Streamline the Design Process
Shifting the study design paradigm from document-centric to design-centric enables clinical resources to focus on the science of the study design without the excessive burden of document management. Key clinical documents—such as study outline and protocol—can be automatically generated through the reuse of structured design information. Researchers can effectively shorten design cycle time and improve standards and SOP compliance through clinical libraries, centrally managed templates and concept lock.
Streamline Study Setup and Execution
Study design metadata, captured in a CDISC PRM-compliant XML data model, can be shared or reused in downstream clinical documents and systems. Designer simplifies study setup and eliminates risks associated with manual programming and interpretation of the protocol by providing Designer Gateway to drive easy integration between Designer and Rave EDC/CDM and Designer Web Services to simplify deep integration between Designer and other clinical technologies.