RWE-ready eTMF for 24/7 transparency in your documents

Jun 14, 2023
RWE-ready eTMF

As we all know, the eTMF structure for RWE studies differs from a general TMF Reference Model.

Here’s the list of main differences:

To make everyone’s lives easier, we added a template for RWS to our eTMF – you can select it when you create an eTMF structure for the project from the list of default templates. 

There are five main aspects to the template that we’ve included to make sure, that the process is as smooth as possible:

  • Standardization: A template ensures standardization in the format, structure, and content of RWE documents within the eTMF. It provides a consistent framework for capturing and presenting real-world data, facilitating comparability and analysis across different studies or projects.
  • Data Integrity: RWE documents often involve complex data sets and analyses. A template helps ensure that the data and analysis methods are documented consistently and accurately, maintaining data integrity and reliability.
  • Efficient Data Collection: A well-designed template streamlines collecting and organizing real-world data. It provides predefined sections and prompts for capturing relevant information, making it easier for researchers and data analysts to structure and input the data efficiently. 
  • Collaboration: RWE often involves collaboration between stakeholders, including researchers, clinicians, data scientists, and regulatory professionals. A template facilitates effective collaboration by providing a common language and structure for sharing and reviewing RWE documents, ensuring clarity and understanding among team members.
  • Quality Control: Templates serve as quality control tools for RWE documents. They enable consistency checks, peer review processes, and verification of adherence to predefined standards. This ensures that the RWE documents meet the desired quality criteria before being finalized and included in the eTMF.

Here’s how it looks like:

So now, when working in Flex Databases eTMF, you can set up your RWE study in minutes and eliminate the burden of structure creation from your team. 

Reach out to our BD team at to see for yourself, how easy it is to set up an RWE study. 

More about our eTMF

Effective Site Selection Strategy
Strategies for Effective Site Selection and Management in Clinical Trials

Effective site selection and management are critical components of successful clinical trials. Choosing the right locations and overseeing their operations can significantly impact the trial’s timeline, budget, and ultimately, its success in delivering reliable data. This article explores essential strategies for optimizing site selection and management, highlighting key considerations, practical tips, and the role of […]

Learn more
How to Choose the Right eTMF System and Vendor

Handling a Trial Master File (TMF) can be tough for clinical teams, but it doesn’t have to be. Old systems with outdated file sharing methods or homemade systems with spreadsheets or paper can make managing sensitive trial data risky. Over the past decade, electronic Trial Master File (eTMF) systems have helped many biopharma companies and […]

Learn more
Benefits of AI in eTMF
Revolutionizing Document Management: How AI Transforms Trial Master Files

In today’s busy world of clinical research, managing documents efficiently is crucial. Imagine being able to organize hundreds of documents in just minutes. Here’s how Flex Databases’ AI-powered Trial Master File (TMF) system makes this possible. From Chaos to Order in a Few Clicks The process is remarkably simple. Users can drag and drop a […]

Learn more
AI in eTMF
The Use of AI in eTMF

While AI might sound futuristic, its role in document management is simply the next step in automation. Imagine a system that automatically files the documents and assigns relevant metadata. This is now possible with Flex Databases’ AI-powered solution.  But before we delve deeper, let’s address a key point: AI is not a magic bullet. It’s […]

Learn more

Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.