The completed integration is expected to enable the rapid transfer of Phase I data and metadata collected in ALPHADAS into Medidata Rave.
ALPHADAS is a multi-study, schedule-driven, automated workflow system with staff and subject management tools, as well as barcoded sample tracking and management.
It is designed to help sponsors and investigators around the world improve the speed, safety, quality and efficiency of Phase I trials, minimizing data queries while providing clean data in real time.
Sponsors can benefit from Rave data management capabilities for Phase I trials and more easily view clinical data from all trial phases for a particular treatment in Rave.
Moreover, with both the study metadata and study subject data captured in ALPHADAS moving to Rave, sponsors can take advantage of advanced Rave capabilities in data management, including easy query communication, coding and insightful reporting.
The integration also enables sponsors using ALPHADAS for Phase I data capture to make use of Medidata Rave Safety Gateway, a configurable EDC-to-safety system interface that streamlines the reporting of serious adverse events by eliminating the need for duplicate data entry.
Logos Technologies CEO Giles Wilson said the integration provides an automated workflow from bedside procedure direct to the sponsor and brings benefits to their clients and the market as a whole, raising the bar and opening up unprecedented opportunities in early phase studies.