Edge Regulated Content Management (RCM)

The industry’s first end-to-end content & data collaboration platform that actively maintains inspection readiness.

Seamlessly manage regulated content

Edge Regulated Content Management is the first end-to-end content and data collaboration platform that actively maintains inspection readiness. Unified within the Medidata Clinical Cloud, Edge RCM allows users to create, store, approve and jointly work on regulated content (such as eTMFs, SOPs and End of Study Media) in a single application with cutting-edge UX capabilities

 

Features and Benefits

Fully Validated, Highly Secure

Fully-validated, 21 CFR, Part 11 and Part 820-compliant Cloud-based content management collaboration platform with applications that enable storing, reviewing, approving, and retrieving regulated content. 

With first of its kind, Live Content Verification technology, verify content integrity every time content is read or written. Introducing a higher compliance standard and actively ensuring inspection readiness.

Incredible User Experience

Built with incredibly intuitive role-based workflows and mobile functionality, Edge RCM is easy to use, even for the occasional user.  Integrated with the Medidata Platform, data and content integration simplifies workflows through content pre-population.

Simplifying Search

Edge RCM powers search.  Edge RCM’s advanced search algorithms, based on content, title and or metadata, makes searching regulated content simple. Powered by auto-naming and metadata, content is standardized and easier to find.

Fully integrated with Box, Edge RCM provides the industry’s only single platform for searching and managing both regulated and non-regulated content, providing one platform for all your collaboration needs

Manage content with ease

Edge eTMF

Simplifies the filing and oversight of TMFs and ensures TMF completeness and compliance through artifact pre-population, role-based workflows, and intuitive reporting and dashboards.   Learn more.

Edge Quality with SOP

Provides intuitive, pre-configured workflows for managing and maintaining compliance of SOPs with full content creation/editing/approving, read & acknowledge capabilities, and complete mobility.

Edge Archive

A single repository for archiving regulated content, enabling the migration, search/access and structural preservation of regulated content coming from external sources. 100% of the access, 100% of the compliance, at a fraction of the cost.

End of Study Media 

Simplifying the EOS document compilation with automation, standardization and controlled access to ensure sites are compliant with regulatory requirements for NDA submissions and audit-ready.  

 

 

 

Meet our Medidata Edge RCM Users

Learn how Life Science, Medical Device, and CRO customers can overcome common regulated content compliance and collaboration challenges with Edge Archive.

talk to a representative

We can customize product solutions to your unique clinical trial needs. Connect with us to learn more about Medidata and discover how we can help you accelerate your clinical trial process.

Additional Resources

In the News

End of Study - Rave EDC and Edge RCM

White Paper

Beyond Compliance: Regulated Content Management And The Digital Revolution

Fact Sheet

Edge eTMF

Fact Sheet

Edge Archive

Case Study

Zosano Pharma Adopts Edge Regulated Content Management To Streamline Search And Increase Compliance