Medidata Designer Harness Protocol Planning for Powerful Trial Efficiencies Medidata Designer™ (formerly Fast Track Designer XCP®) is a breakthrough for trial design, with benefits that carry through study setup and execution—from authoring the protocol to setup of downstream systems such as electronic data capture (EDC), data analysis and submission tools. Bringing the benefits and efficiencies of electronic management to the critical process of designing research protocols, Medidata Designer provides a familiar authoring interface that captures key protocol concepts electronically as the study documents are being created. In addition, Designer's flexible work-flow model and robust knowledge management features enable companies to enforce corporate data standards, share knowledge across studies and leverage existing process, training and technology investments. It enables a true end-to-end eClinical strategy by capturing information at the start of the study development process that can be seamlessly shared with applications used throughout the trial process, such as the EDC, clinical trial management, data analysis and trial submission systems. Designer is the only CDISC ODM-certified application capable of generating structured protocol information which will ensure companies can comply with CDISC Study Data Tabulation Model (SDTM) standards, the emerging global industry standard, as well as achieve immediate operational benefits. Medidata Designer, used in some of the world's top-tier pharmaceutical companies, can: Save cost and time through reduction of the ambiguities that lengthen trials, such as protocol amendments and multiple site queries Realize greater returns from the investment in installed e-clinical technologies Reduce the number and type of procedures specified in the protocol by using benchmarking data at the point of decision making Compress the study startup stage by automatically populating large segments of the EDC system.