DOCUMENT IT Sponsor News
The 11th Edition of the Life Science Forum Basel DOCUMENT IT Sponsor News:
Partnership with Medidata enables Document IT to provide Software and Consulting Support for electronic Trial Master File (eTMF) Systems – Visit us at the Life Science Forum Basel 2018 in the Networking Area to have a look into the Medidata Platform.
SPOTLIGHT: LIFE SCIENCES’ SOLUTION FOR ETMF MANAGEMENT
From trial master files (TMF), contracts, CVs, IRB letters, SOP workflows, and more — clinical trials contain a variety of content from multiple sources. While principal users like clinical operations and quality/regulatory teams at small-to-medium sized companies use inefficient hybrids of paper and computer-based systems, larger companies maintain multiple solutions which typically result in high costs for software, services and validation.
These legacy solutions are dated, siloed and provide disparate user experience for access, search and workflow — leading to low system adoption and increased compliance risks. There is a clear need for a unified solution to manage TMF content that is both cost-effective and quickly deployable. Introducing our new standard offering for addressing these challenges: Medidata Regulated Content Management (RCM) — a 21 CFR Part 11 compliant, validated, content integrity and collaboration platform for the modern digital workplace.
THE FIRST END-TO-END DATA & CONTENT COLLABORATION PLATFORM THAT ACTIVELY MAINTAINS INSPECTION READINESS
Medidata eTMF is a collaboration platform that empowers everyone — sponsors, sites, CROs — to seamlessly manage regulated content and actively maintain inspection readiness. Unified within the Medidata Clinical Cloud, Medidata eTMF is flexible and configurable, allowing users to create, store, view, edit and jointly work on an entire TMF life cycle in a single application with cutting-edge UX capabilities. With live content integrity verification, life science companies can now use this fully-validated 21 CFR, Part 11 and Part 820-compliant system to ensure constant compliance throughout the clinical trial lifecycle.
• Complete TMF lifecycle workflow
• Robust notifications on change requests, expiring documents, etc.
• Role-based workflow
• Intuitive status reporting and dashboard(s)
• Configurable TMF folder structures
• DIA eTMF Reference model out of the box
• Document placeholders provide the ability to create full “package” of required documents for study, country, site, and investigator objects
• Support audit readiness
• Import/bulk upload supporting migrations
• Rapid implementation as quick as six weeks
• Mobile enabled for content search and access on-the-go
• Deep integration with Box, the leading enterprise content management platform, allows users to find both regulated and non-regulated content in one search