Study Records Collaboration

Trial Interactive's Study Records Collaboration is a configurable clinical document collaboration solution designed for sponsors, CROs, and investigative sites involved in any phase of a clinical trial. It provides a centralized environment for sharing, authoring, and approving documentation, with seamless integration into downstream systems including LMS, study start-up, eISF, and eTMF platforms. Study teams benefit from a more complete approach to inspection readiness by executing and capturing all document processes within a single platform.

The solution is built to align record workflows with regulatory compliance practices, enabling multi-organization cooperation while maintaining security, efficiency, and a full audit trail. It is suitable not only for clinical trial documentation but also for quality management, regulatory affairs, and beyond.

Core Collaboration Highlights

• A single centralized place to share and collaborate on clinical records across all stakeholder organizations
• Author records by opening MS Word®, Excel®, and PowerPoint® directly from the interface, with a dedicated Collaborative Authoring tool for editing and review by multiple team members simultaneously
• Co-author and collaborate on new records with constant access and visibility to essential documentation
• Complete the end-to-end process with electronic signature for record approvals
• Follow critical processes for metadata, approval, and sign-offs by publishing directly to the TMF
• Align record work streams with regulatory compliance practices covering record authoring, approval, control, and related training

Key Platform Attributes

• Secure: Documents are kept safe with secure hosting infrastructure
• Compliant: Maintains an inspection-ready audit trail throughout all document processes
• Efficient: Speeds time to publishing by streamlining review and approval cycles
• Collaborative: Enables multi-organization cooperation across sponsors, CROs, and sites
• Automated: Launches approved content directly to LMS and eTMF systems

Record Management Capabilities

• Configurable indexes, workflows, record types, required records, and dashboards to support a wide range of content management needs
• Create dedicated rooms to share and collaborate on clinical records for clinical trials, quality management, regulatory submissions, and more
• Designed to align record work streams with regulatory compliance practices for authoring, approval, control, and training
• Supports end-to-end electronic signature workflows for record approvals with direct publishing to the TMF following required metadata and sign-off processes

GlobalLearn LMS Interoperability

• For SOP review and approval cycles, the GlobalLearn LMS supports the ability to create mappings from content created in TI Quality Records or TI Clinical Study Record Collaboration rooms
• Approved content can be automatically launched to the LMS, closing the loop between document authoring and staff training

Study Records Collaboration is part of the broader Trial Interactive platform, integrating with clinical study start-up, eISF, eTMF, and LMS endpoints to provide a fully connected, inspection-ready document management ecosystem for clinical development teams.