Ennov CLinical suite

Ennov TMF Archive
Compliant Long Term TMF Storage Solution

  • Secure repository
  • TMF Reference Model structure
  • Supports Health Authority inspections
  • Highly cost effective
  • Easy to navigate

The Trial Master File Archive Challenge

Sometimes, a sponsor doesn’t need an active TMF.  For example, organizations that outsource all of their trials depend on their CRO partners to manage the TMF for ongoing trials.  After a trial has been completed, the CRO will usually deliver the TMF to the sponsor, who then has a long-term obligation for the security and accessibility of the TMF.  This obligation often extends to 25 years or more.

In this case, the sponsor’s needs are simple, but critical.  They must ensure the integrity of the records, limit access to authorized users, and support inspection by health authorities.  Full-featured eTMFs may be excessively expensive and complex for this purpose.

A Simple, Inspectable Archive

Ennov TMF Archive provides a secure archive that is simple to search and navigate.  Inspectors can find and review documents quickly and easily by navigating a folder structure based on the TMF Reference Model.  They can also access and filter a list view of TMF documents, or use a variety of search tools.  They can mark documents as favorites, or access a list of their recently viewed documents.

 

You can control what an inspector can access based on the scope of their inspection, and view a list of which documents they accessed and in what order.

Streamlined Migration and Validation

Documents are easily migrated into Ennov TMF Archive.  The migration process uses the key data present in any TMF (study, country, site, and document/artifact type) to populate studies.  It can also accept and display more advanced information such as document date, expiration date, topic or subject, sub-artifact, or other custom data.

 

Because the solution is specific to TMF archive needs, validation can be completed in a very short period of time.  We provide a complete validation/ user acceptance package to reduce the burden on your users while still providing confidence that the solution is robust enough to meet your needs for many years.

Core Capabilities

Key Features

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