ACTide eTMF

eTMF designed for clinical professionals

ACTide electronic Trial Master File (eTMF) supports studies of any scale and it is backed by a complete cloud-based document management system capable to manage study document workflows. Real-time collaboration between Sponsors and CROs is now the new standard.

Complete study-life cycle

  • Manage your documents and workflows from study start-up to study decommissioning.
  • Boost your study by providing site administrators, sponsors and CROs with an online TMF repository which they can use to create, store, view and collaborate on documents within a single, easy to use interface.
  • Let your Investigative Site Files (ISF) and your eTMF communicate by real-time document access, review and exchange. Transfer key documents from sponsor’s TMF to site’s ISF with just one click.

Features

Collaborate:

Share documents between Sponsor, CRO, sites and countries in a centralized repository for real-time access, review and exchange.

Set automatic quality checks to find missing signoffs and documents.

Control:

Keep your teams up to date with documents status trackers

Manage:

Stay in control by using granular profile-based access.

Benefits

  • Manage all documents in real-time to ensure compliance and audit readiness throughout the trial.
  • Easily search and get access to all your documents in one place.
  • Save costs by increasing your filing efficiency and thus reducing paper, errors and high workloads.

Choose your essentials

Start with a basic configuration and easily scale up to a full-service setup for your eTMF:

 

Basic configuration

Document management system

Default set of approval workflows

Automated reminders to ensure quality and completeness Advanced reporting

Use your streamlined reference model of choice

 

Advanced options

Quarantine protection for uploaded files

Strict workflows to ensure quality and completeness

Advanced reporting

Mobile integration for managing/editing eTMF documents on the go

Complete current DIA TMF reference model (or any alternative model of choice)

Integrated viewer for common file formats

Compliance

  • Compliant with CFR 21 Part 11, GDPR and HIPAA regulations
  • Compliant with extensive audit trails, access control, lifecycle management and version control of clinical documents and records
  • Support of the Drug Information Association’s (DIA) TMF reference model

Time & Budget

High productivity performance
Find out more

Products & Services

ACTide Clinical Data Service for your clinical trial 
Find out more

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