CORE FEATURES

ComplyDocs eTMF provides a set of features that allows for real-time management of your Trial documents; ensuring compliance and audit readiness. At the end of the trial, the approved and fully documented eTMF can be exported to easily integrate into your submission software. 


Real-Time Dashboards & Reports

Gain real-time insight into the health of your TMF with simple, easy-to-navigate reports.

  • Identify missing or incomplete documents in minutes
  • Monitor and identify key issues affecting document quality
  • Adjust report filters for more detailed insight
  • View filing progress for a trial site, milestone, or event
  • Eliminate time-consuming manual reviews and updating spreadsheets

 

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Secure, Role-Based Access

Flexible access and management of TMF content in a secure, compliant environment.

  • Configurable role-based access control, from read-only to full access rights
  • Designate certain users as QC reviewers, to finalize documents as TMF-ready
  • Audit trail captures all system activity
  • Quick access to all studies through a desktop application
  • Upload through encrypted connection to secure, backed-up storage

 

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Instant Document Retrieval

ComplyDocs eTMF is equipped with advanced searching and viewing features which ensures that every document can be retrieved quickly.

  • Powerful search engine for both file content and metadata
  • Search results appear instantly, with adjustable columns & filters
  • Pre-configured document “Views” or filters to monitor filing in different ways
  • Pin favourite files and folders to the home page for instant access
  • Create and view links between related files, even across different TMF categories

 

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Simple Uploading & Filing

ComplyDocs eTMF provides one simple interface for uploading, classifying, and tagging documents – no need to navigate complex menus and subfolders.

  • Drag and drop documents of all types into one central repository
  • Use the “Metadata Card” to tag documents with essential metadata such as site, date, filing level, expiry, version, and more
  • Classify using the TMF Reference Model
  • Create links between related documents
  • Add comments and record details from QC review
  • Integration with Outlook to file emails directly from email inbox
  • Receive email notifications for document uploads or reviewing tasks

 

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Review & QC Workflow

Built-in workflow routes documents through a QC review process, reducing manual work and ensuring quality issues are resolved as they arise – not weeks or months later.

  • All documents captured in a pre-configured workflow for Quality Control (QC)
  • Move documents through lifecycle stages such as awaiting QC review, to correction alerts, to finalizing the document as inspection-ready
  • Receive notifications on documents awaiting review or flagged for corrections
  • Changes and previous versions tracked in an easy-to-view Document History
  • Integrates with reporting: see a summary of overall quality of your eTMF content
  • Customize the workflow to add lifecycle stages or assign reviewing permissions

 

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Support for TMF Reference Model

ComplyDocs eTMF has built-in support for the DIA TMF Reference Model for identifying and classifying trial documents. It provides a standard set of categories and metadata to effectively manage all TMF content. With widespread adoption by many Sponsors and CROs across the industry, using this common language for organizing documents simplifies processes such as trial set-up, filing essential content, file exchanges or transfers, archiving, and audits.

 

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Setting up an eTMF for your Clinical Trial?

Download our eTMF Implementation Checklist and get a head start.