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Ennov CLinical suite

Ennov eTMF
Electronic Trial Master File Software

  • Full featured eTMF software
  • Highly configurable
  • Metadata based document model
  • Easy and intuitive searching
  • Scalable and secure
eTMF documennt tracking

The Trial Master File Challenge

Management of essential trial documentation is, indisputably, one of the most time consuming and costly activities associated with conducting a clinical trial. ICH E6 guidance on Good Clinical Practice (GCP) specifies an inventory of over 200 discrete documents that must be managed before, during and after the trial.  

Any or all of these documents must be available for audit by the sponsor and for inspection by the regulatory authorities, and considering the massive volumes of documentation involved in the process, the effective management and exchange of study documentation can have a significant impact on the cost and time to complete a clinical trial.

Yet despite the costs in time, effort and money, the trial master file (TMF) is often still managed through a combination of paper and simple shared folders, scattered across many locations in various countries.

Gain Control of Your Clinical Documentation with Ennov eTMF

Ennov eTMF is an electronic trial master file solution to collect and manage essential trial documents in a centralized repository and makes them available to clinical teams, via the internet, from any location at any time.  The benefits of using Ennov eTMF include streamlined processes, increased transparency, simplified tracking and enhanced security. 

Ennov eTMF leverages the power of our comprehensive Enterprise Document Management software (Ennov Doc) and Business Process Management (Ennov Process) software, as they serve as the foundation of the solution. The robust metadata driven document model, highly configurable workflows,  powerful searching and flexible views combined with our engaging and intuitive user interface provide all the functionality required to effectively and efficiently manage your clinical trial documentation.

Standards-based but Highly Flexible eTMF Software

Ennov 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.

Core Capabilities

  • Pre-configured document inventory
  • Advanced life cycle management
  • Flexible rights management
  • Automatic PDF rendering
  • Scanner integration
  • Pre-configured views and tracking dashboards
  • Required documents list

Key Features

  • Integrated worklist dashboard
  • Configurable document types, workflows and views
  • Automated email notifications
  • Intuitive user interface
  • Integated PDF viewer
  • 100% web-based
  • 21 CFR Part 11 compliant

Why Choose Ennov ?

Hundreds of corporate customers trust Ennov

Over 19 Years of experience providing Clinical solutions

150+ life science customers, 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

Available as cloud-based or on-premises deployment

You can switch between deployment options at any time.

We make you autonomous

System configuration and management require no IT skills

Improved security and optimized performance

Data is hosted locally for total flexibility. Single-tenancy minimizes business interruptions.

cloud industries

Cloud-based or On Premises

multiplatform

Multi-Platform

iso 2015 ready

ISO 9001:2015 certified

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