OpenText Electronic Trial Master File Management for Content Suite Platform by S
By STRATESYS TECHNOLOGY SOLUTIONS, SL
Electronic Trial Master File Management for Content Suite Platform by Stratesys is a modular solution part of GxP Suite and designed to give the Clinical Trials department of a Life Science organization and Clinical Research Organizations an application that can help to improve and innovate their information recording related to the Clinical Trials performed. This modular solution covers the full Trial Master File Process, complying with DIA Reference Model (v 2.0 and v 3.0).
• Task oriented with a 100% mobile user interface to improve productivity and adoption
• Includes project management components to govern TMF timing and completeness
• Tracks TMF evolution between Clinical Phases
• Supports location and distribution of content based on text or trail classification data
• Includes Quality Control Workflow for review and approval of content
• Preconfigured security model with predefined roles
• Secure External Collaboration features for CRO’s and other third parties
• Enable collaboration with OpenText Brava!
• Enable the management of the eTMF data, content and milestones in one single application, speeding-up regulatory audits
• Multi Device and multi access to increase and simplify user adoption and reducing training costs
• Simplified maintenance with Business Users administration tools