Case Study - eSource

A world class research site came to us with a need to implement an eSource solution which replaces the traditional paper-based data collection methodology at sites. The main goal is to streamline data collection and expedite the time to market for drugs and medical devices. The problem with data collection methods using paper source methods is that it is prone to many errors which end up costing the pharmaceutical companies a lot of money as expert resources are needed to verify and clean the data.

Technical Requirements

1. The platform should allow for front-end validation checks to be easily configured to ultimately allow for cleaner data to be collected.

2. The platform should be fully validated according to the FDA CFR Part 11 guidelines

3. The platform should have full role-based access as well as a detailed audit trail.

4. The ability for the platform to be device agnostic was a big requirement.

Solution

1. We took the foundation of our FDA approved Electronic Data Capture (EDC) platform to create Nukleus eSource.

2. The platform is web-based and follows responsive design principles which allows for it to work perfectly on any device with access to a modern web browser.