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 lifecycle

- Manage your documents and workows 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.

eTMF 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.

eTMF 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.

CONFIGURATIONS

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
Use your streamlined reference model of choice

ADVANCED CONFIGURATION

Quarantine protection for file uploads.
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.

BE COMPLIANT

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 for the Drug Information Association’s (DIA) TMF reference model.

INFORMATION REQUEST

Want more information about our solutions?
Contact us today.



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