Optimize Study Design and Improve Line of Sight
Medidata Designer® is an innovative protocol design solution that helps sponsors focus resources on intelligent study design—improving its quality, alignment and efficiency while also helping to streamline trial execution through reuse of design information in downstream systems. Designer allows users to structure protocol design components and make more informed decisions through line of sight linkage between study objectives, endpoints and procedures, overlaid with industry benchmark data.
Optimize Study Design
Designer's robust data model enriches protocol metadata with end-to-end clinical context, revealing critical insight into key operational metrics that were once difficult or impossible to obtain during protocol development or execution. The real-time quality check and visibility into study metrics and industry benchmarks (e.g., procedure cost, complexity and quantity) allow sponsors to focus on important objectives and eliminate unnecessary procedures and data collections, realizing substantial cost savings. The impact of design decisions can now be dynamically anticipated by querying data sources, such as the Medidata PICAS® database for study costs, industry benchmarks, historical references and other performance metrics. Effective protocol design can pave the way for more efficient study execution and continuous process improvement in a true, closed-loop trial development environment.
Designer shifts the study design paradigm from a document-centric process to a design-centric one. A read-only word output synopsis document following CDISC PRM Standards is a deliverable (rather than the center) of the study design process. Researchers can effectively shorten design cycle time and improve standards compliance through reusable libraries and concept lock. And since Designer separates the Design Guide from the MS Word document, protocol teams are able to focus on the definition of core clinical concepts and study design early without the need to produce a properly formatted word document.
Identify and Mitigate Risk
One of the risks of successfully conducting a study is protocol deviations and non compliance events that can occur with study subjects and investigators. These factors can cause deviation and non-compliance actions later in the execution phase of the study, increasing its risk profile. Designer’s line of sight and structured protocol design elements help sponsors identify and correct potential design element misalignments, reducing complexity during the planning phase of the study.
Capture and Reuse Study Content Downstream
Designer provides various mechanisms for the reuse and sharing of study design data, which includes document and report exports as well as systems integrations to accelerate budgeting, study build and execution. Designer produces a study design synopsis document in a CDISC PRM-compliant format, along with various Excel reports which can be shared or reused in downstream clinical documents.
Designer simplifies the EDC study build and eliminates risks associated with manual programming and protocol interpretation by providing Designer Gateway to drive easy integration between Designer and Rave EDC/CDM. Study budgeting is enhanced through data integration with Grants Manager, and Designer Web Services (DWS) allow for additional third-party clinical technology integration. Designer also provides XML uploads to ClinicalTrials.gov to satisfy government requirements for upcoming trial registration.