e-TMF/e-ISF
GETTING IT RIGHT, FIRST TIME.
Our e-TMF/e-ISF solution is a regulatory compliant, cloud based, user friendly, trial master file in electronic (digital content) format for organizing and storing documents, images, and other digital content of clinical trials.
Managing documents’ lifecycle in clinical trials without a system that offerS interoperability, collaboration and automated compliance features is a resource intense “near impossible mission”, reason why CLINERGY’s e-TMF/e-ISF solution has been developed to provide sponsors with a very cost-effective way to gain full control of study documents, anywhere.
BE INSPECTION READY
Fully compliant with FDA CFR 21 p.11 standards, our e-TMF/e-ISF meets regulatory requirements, including:
- Digital content archiving
- Security standards
- Access control
- Change controls
- Audit trail
- System validation
Advanced Analytics
- Gain powerful and actionable insights
- Always know the status of all your documents
- Instant notifications of expiring documents and missing signatures
Efficient Organization and Workflow
- Inbuilt eTMF organization structure and configurable Organization structure for any Organization needs
- Robust document lifecycle with Author, Review and eSign/Approval workflow.
Enhanced Security
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- Role based directory security
- Controlled File Types
- Password Protected file download
Faster User Adoption
- Business teams, CROs, Site personnel, external vendors and others can be trained on this system within a few hours
External Systems Integration
- Integrate with CDMS/ CTMS systems to get study, site, patient and other information and dynamically create directory structure
Sharing and Collaboration
- Allows a user to invite external parties to upload and work collaboratively on documents system in a controlled method
Extendable Document Management System
- System can be used as a focused eTMF or as general document management system for the entire organization
