Harmony between your Electronic Trial Master File (eTMF) and eISF is crucial for the investigator, sponsor, and monitor involved in a trial—and better cooperation between the two can reduce regulatory compliance risks. Solve the challenges of collecting and storing documents by implementing Viedoc’s eTMF solution. With the help of permissions, you can choose to use our system as either an eTMF or an eISF.

What are the benefits of two systems in one place? 

It’s a common concern—I have patient information that shouldn’t be available to sponsors—and this leaves you wondering whether an eTMF/eISF solution can provide the privacy needed for your trial. Thanks to an easy setup of end-user permissions, Viedoc’s solution makes it possible. Here is a list of benefits that come with Viedoc’s eTMF/eISF solution: 

1.    Roles and responsibilities are set in one place

TMF Managers can set up end-user permissions based on existing user roles and easily control user access on many levels. Setting customized permissions ensures each user has access to exactly what they need to see and never has access to what they shouldn’t—which is reflected throughout the Viedoc system. 

“Our system can handle role-based access. That’s how we are able to grant users access to specific zones, sections, and artifacts, and thereby allow the system to be used as both the eTMF as the eISF,” said Greg Tullo, Vice President (VP) of Professional Services for the Americas. 

2.    Consolidate your eTMF/eISF management into one system

Stop trying to juggle all the extra work required to manage different systems and access your data within one single system. Viedoc’s eTMF is accessed via the URL and with the same user credentials as the rest of the Viedoc eClinical suite—accessible 24/7—with only a single login needed. Viedoc is your one-stop solution.

“Before EDC systems revolutionized the clinical research industry, sites were burdened with binders—and now they're overburdened with different systems. Everything is linked within Viedoc,” said Sverre Bengtsson, Co-founder and Sr. VP of Strategic Relations.

3.    Train your team in under an hour

Training on our eTMF/eISF system generally takes less than 60 minutes. So, forget multiple sessions and hours of lost time. The short setup process leads to significant time efficiencies for you and your team. The quick setup means your team will gain confidence to navigate the system and focus on the discoveries that matter.

4.    Intuitive documentation drop zone

Our eTMF supports drop zones which are folders outside of the eTMF structure where you can upload files to include in the structure later—and anyone with access to the study eTMF can do so. Users have two options to work with—shared drop zones and private drop zones. Shared drop zones are accessible to all users with the Manage drop zone permission, while private drop zones are only accessible to the user who uploaded them.

5.    User-friendly search engine feature

In clinical trials, there are often several hundred documents to organize—and with Viedoc’s powerful search engine feature, everyone knows where to find necessary documents at all times. In our system, you can search by document name and content, or use advanced search and filtering options by all document metadata to find the document you want to find with ease. 

6.    Standardized with the DIA reference model 

By default, our template is based on the DIA TMF Reference Model—which allows organizations conducting clinical trials to demonstrate compliance with the standards of good clinical practice (GCP) and standard regulatory requirements. Essential documents are filed in one place, so that the investigator, sponsor, and monitor can manage a trial successfully. 

While the DIA model is the standard we start with, TMF Admins can modify it themselves. There’s no need to hire consultants to customize your structure or wait for a service provider to make costly backend changes with our adaptable, self-service solution.

7.    Consistent with the market standard for exporting records

The archive is also standardized with the Exchange Mechanism Standard (EMS), the market standard for exporting records after your study has ended. According to the regulations, the content of your eTMF must be readily available and accessible upon request, and any changes must be traceable—and all content must be archived for at least 25 years after the end of the trial. With our eTMF, importation of the contents of your trial into the retention eTMF is simple and hassle-free.

Two solutions in one package

”The interface is extremely intuitive.  We use a folder-based structure that all users are comfortable with,” said Greg.
 
Viedoc’s eTMF gives you two solutions in one package—an eISF for the site side and an eTMF for the sponsor side—so you don’t have to worry about clunky information transfer. Say goodbye to the traditionally cumbersome process and say hello to the shortest setup process on the market.

Do you want more information on how our eTMF can transform your study and help you gain efficiency? Contact us for the next step.