Content Management

Trial Interactive's Clinical Document Management System
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Clinical Study Document Collaboration

Shared workspace for clinical teams to provide Sponsors, CROs, and sites a place to share and author documentation to be used in the clinical trial and, ultimately, archived in the eTMF.

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Quality Documents and Training Management

A central, controlled workspace for quality documentation with connected training management to enforce compliance with quality processes and procedures. 

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Study Training Management

A centralized collaboration room for managing and defining quality documentation that can be distributed as training in the interoperable LMS.

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A practical, secure, and compliant single access point for TMF documentation, supporting all essential document processes and reducing the time, costs, and risks of TMF management.

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Study Start-Up

Accelerate site activation by simplifying the collection, completion, and finalization of critical regulatory documentation necessary for approval to bring a site online.

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An investigator site file solution that reduces administration and improves speed and compliance for site personnel and study teams with digital investigative site binder processes.

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A mobile eTMF that enables site document capture and key e-clinical workstreams anytime, anywhere—saving CRAs weeks of time processing documents.

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General Document Management

A central collaboration workspace to author, edit, and sign/approve departmental documentation. 

End-to-end document lifecycles that publish directly to the eTMF and LMS, creating cultures of inspection readiness and operational excellence.

Electronic Content Management

eTMF & Clinical Operations Documents
  • eTMF Clinical Protocols
  • Study Plans Clinical
  • Research Liaison
  • eTMF Reports
  • Site Activation
  • Required Documents
  • IRB/EC Documents and Submissions
  • SAE/SUSAR Management, Including SUSAR Workflows, CIOMS, and Monthly Safety Review Minutes
Study Collaboration & Shared Workspaces
  • Site Collaboration
  • Sponsor and CRO Collaboration
Compliance Training
  • Investigative Site Training
  • Study Personnel Training on Protocol, Regulations, and GxP and non-GxP training
  • Read and Understands for SOPs and Policy Training Certificates
Organizational Workspaces
  • HR Finance
  • Procurement R&D
  • Non-Clinical CMC IT
Regulatory Documents
  • R&D Documents
  • Communications Logs
  • Correspondence and Commitments
  • Clinical Study Reports Contracts, Legal, Adjudication, Non-Clinical, CMC, Finance/Procurement, HR, CSV/Validation, and Change Control
Quality Documents
  • Quality Documents Policies, SOPs, Work Instructions, and Job Aids
  • Quality Management Plans
  • Deviations and CAPAs
  • Change Control
  • Approved Vendor Lists 
  • Audit Plans, Audit Reports, Responses,and Corrective Action Plans