Ennov eTMF
Electronic Trial Master File Software
Control your trial documentation. Stay inspection-ready.
- Preconfigured to the TMF Reference Model structure
- Metadata-driven TMF document management and faster search
- Real-time visibility into completeness, QC status, and ownership
- Traceable workflows to support audits and inspections
- Configurable without coding to match your SOPs and operating model
- Secure, scalable deployment options for global teams
What Challenges Does eTMF Software Solve?
Clinical trials generate a high volume of essential documents across sponsors, CROs, and sites. When Trial Master File content is managed across shared drives, email threads, and disconnected tools, teams lose visibility into TMF completeness, QC status, and document ownership. Issues often surface late, when timelines are tight and inspection readiness matters most.
eTMF software (Electronic Trial Master File software) helps solve this by centralizing TMF documents in a structured, metadata-driven system of record. It supports consistent filing against the TMF Reference Model, real-time oversight of completeness and quality, and traceable workflows so teams can collaborate more effectively and maintain inspection readiness throughout the study.
The Trial Master File Challenge
Managing essential trial documentation is one of the most resource-intensive parts of running a clinical trial. Sponsors and study teams must collect, maintain, and retrieve a large set of Trial Master File (TMF) documents throughout the trial lifecycle, and those documents must be inspection-ready for audits and regulatory inspections.
When TMF content is managed across paper, shared drives, and disconnected tools, teams lose visibility into completeness, ownership, and QC status. Version confusion and manual handoffs slow down collaboration across sponsors, CROs, and sites, and issues are often found late, when timelines are tight and inspection readiness matters most.
eTMF software helps address this by centralizing TMF content with structured metadata, real-time oversight, and traceable workflows to support TMF completeness and ongoing inspection readiness.
Gain Control of Your Clinical Documentation with Ennov eTMF
Ennov’s eTMF software helps clinical teams collect, manage, and oversee essential Trial Master File documents in a centralized repository with structured metadata. Instead of relying on shared drives and manual tracking, teams can improve visibility into what is filed, what is missing, and what is ready for QC, supporting stronger inspection readiness throughout the trial.
Ennov eTMF is built on Ennov’s document management and workflow foundation, combining metadata-driven organization, configurable workflows, and powerful search with flexible views designed for day-to-day TMF work. The result is clearer oversight, more consistent processes across teams and partners, and controlled access that supports secure collaboration.
Standards-based but Highly Flexible eTMF Software
The eTMF is a comprehensive solution for managing clinical trial documentation. The document inventory is pre-configured in alignment with the DIA TMF Reference Model and includes all required zones, sections and artifacts.
Ennov eTMF’s metadata-based document model provides the flexibility to adapt this model to your company’s organizational needs. Our intuitive suite of design utilities allow administrators to configure and manage the system without needing IT skills.
Ennov eTMF’s scalability and security enables you to safely manage large volumes of documents – making it the perfect solution for global deployments.
TMF Metrics: The Key to Maintaining TMF Health
Maintaining TMF health requires consistent oversight across three core dimensions: completeness, quality, and timeliness. Ennov’s eTMF software dashboards bring these metrics together so teams can see what is missing, what is pending QC, and what is at risk, then drill down to identify root causes at the study, country, site, or document level.
Configurable thresholds help teams track whether targets are being met at a glance, supporting proactive follow-up and clearer oversight across sponsors, CROs, and sites. The result is better visibility into TMF performance, fewer late surprises, and stronger inspection readiness throughout the trial.
Core eTMF Capabilities
- Preconfigured TMF document inventory
- Lifecycle management for TMF documents and revisions
- Flexible user and partner access controls
- Automated PDF rendering
- Scanner integration
- Preconfigured views and tracking dashboards
- Required document lists to support completeness oversight
Key eTMF Software Features
- Integrated worklist dashboard
- Configurable document types, workflows and views
- Automated email notifications
- Intuitive user interface
- Integated PDF viewer
- 100% web-based access for global teams
- 21 CFR Part 11 compliant
How to Build a Strong Foundation for Commercial Growth
Learn how unifying Quality, Regulatory, and TMF archive management into one system eliminated ongoing CRO fees and helped teams move faster without adding headcount.
When Academic Excellence Meets Regulatory Reality
Building a Complete Research Operations Platform
How an academic research group replaced fragmented, outdated tools with a self-configured, unified platform covering study management, quality, eTMF, and analytics.
Efficiently & Securely Capture & Manage Clinical Trial Information
The Ennov Clinical suite consists of Clinical Data Management applications as well as Clinical Trial Management applications that are available for deployment in the cloud or on premises.
Why Choose Ennov
Over 500,000 users trust Ennov
Over 500,000 users trust Ennov
- Over 25 years of experience providing software solutions for Life Sciences and 450+ Life Science customers, with many more in other industries.
- Modern architecture and interface 100% web-based. Highly scalable. User-centric design.
- Our commitment to your success Very high customer satisfaction, 98.5% of projects delivered on time and within budget.
Providing you freedom of choice
Providing you freedom of choice
- Available as cloud-based or on-premises deployment, you can switch between deployment options at any time.
- System configuration and management require no IT skills, making you fully autonomous
- Improved security and optimized performance. Data can be hosted locally for total flexibility. Single-tenancy minimizes business interruptions.
Cloud-based or On Premises
Multi-Platform
ISO 9001 & 27001 Certified
Electronic Trial Master File Software FAQs
What is eTMF software?
eTMF software (electronic Trial Master File software) helps clinical teams manage essential TMF documents in a structured, inspection-ready way throughout a trial. It centralizes filing, QC, completeness oversight, and role-based access so sponsors, CROs, and sites can maintain control and visibility across TMF health.
What is eTMF software used for?
eTMF software is used to plan TMF expectations, upload and quality check documents, and monitor TMF health as a trial progresses. It supports ongoing inspection readiness by helping teams track what is missing, what is complete, and what needs attention across completeness, quality, and timeliness.
How does Ennov eTMF support TMF planning and completeness?
Ennov eTMF includes Smart Templates that automatically plan the contents of the TMF based on study conditions and entities, generating the document placeholders teams need so filing is more consistent. This reduces manual effort spent building and maintaining document lists, and supports ongoing completeness oversight.
How does Ennov eTMF streamline upload and QC?
Ennov eTMF is designed to streamline upload with a drag-and-drop process and support a risk-based, sampled, and tracked QC process. The goal is fewer manual steps, faster processing, and better use of limited resources while maintaining oversight of TMF health.
What dashboards and metrics matter most for TMF health?
TMF health typically depends on completeness, quality, and timeliness. Ennov eTMF provides dashboards and reports that help teams understand priorities, issues, and risks, not just display counts, so TMF oversight becomes a continuous process throughout the trial.
Can Ennov eTMF support health authority inspections?
Yes. Ennov eTMF is designed to support hands-on TMF inspections by health authorities and provide the traceability and visibility needed to demonstrate inspection readiness.
How is Ennov eTMF aligned to the TMF Reference Model?
Ennov eTMF includes a TMF Reference Model ready configuration that can be adapted to your needs. This supports consistent filing structure and more reliable oversight across studies and teams.
Does Ennov eTMF include CTMS capabilities?
For organizations that need an eTMF now but are not ready for a full CTMS project, Ennov eTMF includes basic CTMS capabilities to manage study, country, site, visit, and investigator-related information, plus automated planning tied to those entities. It can be upgraded to Ennov’s full CTMS or integrated with another CTMS later.
How is Ennov eTMF deployed and managed?
Ennov eTMF is available as cloud-based or on-premises deployment, and is designed for global business-user access, including sponsor and CRO partners.
Discover Our eTMF and other Regulatory Resources
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