Swiss Medical Device Company Improves Clinical Data Collection and Management with Greenlight Guru Clinical

The Challenge: Managing clinical data in spreadsheets

Company S had previously used Excel to manage the clinical data they gathered from clinical investigations into their devices. But managing that data in spreadsheets was creating headaches for their Clinical Affairs Manager.

Once the clinical data was in Excel, the team couldn’t see if someone made a change to the document, when it had occurred, or why it had happened. In other words, it was impossible to maintain a proper audit trail. 

On top of that, it was extremely difficult to manage and respond to queries about the data. The Clinical Affairs Manager at Company S was forced to combine scanned case report forms (CRFs) into an enormous PDF to send around for feedback. 

Document management and control were simply becoming too much of a problem to ignore. Company S knew they needed an electronic data capture (EDC) system before they started their next clinical studies.

The Solution: Greenlight Guru Clinical

The team at Company S looked at several other EDC solutions, but eventually decided on Greenlight Guru Clinical for its ease of use and its MedTech-specific features.

Company S didn’t want a solution that wasn’t user friendly or required coding experience to get up and running and use features. Fortunately, Greenlight Guru Clinical makes getting started simple, and allows users to build studies from scratch without any coding knowledge.

The Clinical Affairs Manager at Company S found the training process to be straightforward, and was able to start building a study immediately after completing the training.

The Results: Improved data collection and management

Company S is currently using Greenlight Guru Clinical for two clinical studies, with another study planned. The two current studies are both Post-Market Clinical Follow-Up studies for their class IIb device in Europe. Their upcoming trial is a premarket approval (PMA) study for what will be a class III device in the US.

Here’s what they got by switching to Greenlight Guru Clinical for their studies:

An impeccable audit trail

Once they switched to Greenlight Guru Clinical, the data management issues Company S had seen with spreadsheets disappeared. Now, it’s always clear who introduced any change and when it occurred due to the extensive system audit logging that tracks every action on both the user and study levels.

Even better, the user permission controls in Greenlight Guru Clinical ensure that only those with the correct permissions can access and make changes within the system. That means the clinical data the team collects is now more reliable and trustworthy.

The issue with queries has been resolved, as well, because now the Clinical Affairs Manager can simply go directly to the queries within the system and view the appropriate forms from there. 

As that same Clinical Affairs Manager at Company S put it, “This is definitely easier, and it’s making my life easier as well.”

Study setup simplified

In the field of medicine that Company S works in, study outcomes are often very similar. In other words, it doesn’t make sense to build the same study from scratch over and over again. That’s why the team at Company S loves using Greenlight Guru Clinical’s study duplication feature. 

When they have one study that was well-developed and deployed, they can copy and paste that study within Greenlight Guru Clinical and then pick and choose any individual forms that need to be changed or improved in some way. 

Knowledgeable and fast customer support

The Clinical Affairs Manager at Company S told us that in addition to the ease of use and data management, the main reason he would recommend Greenlight Guru Clinical is the customer support. 

The team at Company S felt like they could always count on the Customer Success team at Greenlight Guru Clinical to quickly and thoroughly get them an answer any time they had a question. Greenlight Guru’s Customer Success team was there to help them with anything they were struggling with.

What’s next for Company S?

The company is looking forward to using Greenlight Guru Clinical for their next clinical trial, which will be part of the PMA process for getting their device to market in the US.