European IVD Startup Gets Fast, Accurate Clinical Data

Company A is a startup based in Europe that is developing a unique in-vitro diagnostic device. Company A is still in the pre-market stage, but has begun clinical studies on their device.

The Challenge: Getting accurate clinical data from multiple pre-market studies

Company A is bringing a novel in-vitro diagnostic device to market, so they needed to carry out two clinical studies of the device in order to validate its performance. Their first study was carried out in a single country, while the second study was carried out in multiple countries, both with 200-300 subjects. 

During the first study, there were errors in the data entry that had to be cleaned up later on. This was time-consuming and inefficient, and Company A wanted a system that would allow them to quickly and accurately capture the clinical data from their second study. They didn’t want to spend time cleaning data because of errors in manual data transfer.

Why Company A chose Greenlight Guru Clinical

For their multi-site clinical study, Company A decided to use Greenlight Guru Clinical (formerly SMART-TRIAL). 

The Clinical Operations Manager at Company A was pleasantly surprised at how simple it was to use. She was able to set up the next study using a training video and the user manual. 

The clinical team at Company A also discovered there were many features in the Greenlight Guru Clinical system that would make their data collection easier and more accurate. So, they took advantage of features like the API, white labeling, and process and validation rules, and the adverse event module. 

They also started using Greenlight Guru Clinical’s customizable document templates, which facilitate compliance with FDA requirements and ISO 14155:2020.

The Results: Efficient data collection without data entry errors

Working directly with Greenlight Guru Clinical was the right move for Company A. 

By using the API, validation rules, and the export labels, Company A was able to eliminate the data entry errors they had seen in their first study. This meant less cleaning of the data after the fact, which significantly sped up the data collection process.

Timely and helpful customer service

Company A also took note of the excellent customer service they received from the team at Greenlight Guru Clinical. Instead of waiting days for an answer to their questions, they received immediate follow-up. 

Just as important, it was clear that the team at Greenlight Guru Clinical understood their questions and knew how to clearly answer them.

According to the Clinical Operations Manager at Company A, that isn’t always the case when you’re using an EDC system—especially one that isn’t built for MedTech clinical trials. 

Compliance comes standard

Finally, by using the pre-validated templates, the clinical team could rest easy knowing they were in compliance with FDA regulations and the requirements of ISO 14155:2020. 

What’s next for this European startup?

They are looking forward to getting the CE mark and to bringing their novel device to market. If and when more clinical studies are required for their device, they’ll be using Greenlight Guru Clinical once again.