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Content Management

Trial Interactive Clinical Document Management System

SIMPLIFY CLINICAL DOCUMENT LIFECYCLES!

Sponsors, CROs, and investigative sites around the world improve compliance and speed and reduce risk by centralizing clinical content. Interactive document processes and document management services for oversight, quality management, and submissions enable a full, author-to-archive experience. 

START COLLABORATING NOW! WE HAVE A SOLUTION FOR YOU.

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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eTMF

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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eISF

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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myTI

A mobile eTMF that enables site document capture and key eClinical 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. 

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

  • Expedite Document Creation

  • Approvals Enable Effective Oversight Forecast Approvals

  • Submissions Simplify Entire Document Lifecycles

  • Audit Reporting

  • Automate Processes

  • Improve Stakeholder Collaboration

  • Seamlessly Publish to the eTMF

  • Seamlessly Publish to the LMS

  • Improve Quality Management

  • Activate Real-Time Inspection Readiness

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
Demo Request

Study Collaboration & Shared Workspaces

  • Site Collaboration
  • Sponsor and CRO Collaboration
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Compliance Training

  • Investigative Site Training
  • Study Personnel Training on Protocol, Regulations, and GxP and non-GxP training
  • Reading and Understanding for SOPs and Policy Training Certificates
Read a Blog about Compliance Training

Organizational Workspaces

  • HR Finance
  • Procurement R&D
  • Non-Clinical CMC IT
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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
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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
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