The team at Loop Medical is conducting clinical studies of their onflow blood collection device. Based in Switzerland, the Loop Medical team’s goal is to revolutionize clinical diagnostics by providing easy and painless blood collection technology that is accessible to everyone and empowers patients to take control of their health.
The onflow device gives patients the ability to seamlessly fit the blood collection process into their lives without requiring labs to reinvent the way they work. By transforming the blood collection process, the onflow device will enable earlier detection, more accurate diagnoses, and better patient outcomes.
The Challenge: Leaving paper behind and finding the right EDC system
Prior to the study in South Africa, the team at Loop Medical had performed small internal and feasibility studies and used paper to capture the results. However, they quickly came to see the limitations of using paper for their clinical data collection.
There were, of course, the opportunities for errors and delays in transcribing data from paper to an electronic system. But using paper also meant the team would never have real-time insight into their data.
As Alison Moran, Clinical Affairs Manager at Loop Medical, put it, “Moving away from paper was super important because we’re rarely going to run a study that’s just in Switzerland, and we need to be able to look at the data as it's coming in.”
Loop Medical was working with a partner in South Africa and had a pilot study coming up at their site in South Africa. As a small team, they couldn’t afford to keep employees at both locations for months at a time. They needed an electronic solution that would give them access and insight into their data as it came in from the field.
The Solution: Greenlight Guru Clinical
Loop Medical began taking demos from different EDC providers and looked into open access solutions.
It didn’t take long for Greenlight Guru Clinical to stand out. Moran said that Greenlight Guru Clinical’s real-time access to data and the fact that it was built specifically for MedTech devices was the biggest appeal. Other EDC systems they looked at were built for pharmaceutical trials and tended to be overly complex.
As Moran said, “Sometimes these systems can get bogged down with so many layers that it makes it more difficult to use, and it’s not intuitive for a clinician to fill out.”
But with Greenlight Guru Clinical, Moran and the rest of the team got everything they needed—without anything they didn’t.
The Results: A true partnership that saves time and money
From day one, Loop Medical knew they had made a great choice by using Greenlight Guru Clinical for their clinical study.
Fast and simple study setup
The first thing Moran noticed about Greenlight Guru Clinical was how simple it was to set up a study.
That ease of use isn’t the result of a lack of functionality, either. Loop Medical used both the eCRF and ePRO modules and could tell that the add on features saved them both time and money.
“We weren’t compromising or making concessions. We were getting everything we wanted.” said Alison Moran, Clinical Affairs Manager.
Real-time access saves time and money
Moran stressed that as a small team, the real-time access to clinical data was invaluable.
Instead of waiting on weekly or bi-weekly meetings to get insight into how the study was progressing, the team always had access to clinical data as it was collected. That’s extremely important, because if the data indicates an issue that needs to be addressed—a continent away—the team needed to know that immediately in order to fix it.
Not only does that save time, but money, too. “I don’t have to be on-site the whole time. I’m not paying for flights and hotels for a month. I can just check in twice a day with Greenlight Guru Clinical. As the only person on the clinical team, it gives me more bandwidth,” Moran said.
Unrivaled customer support
A great product can be undercut by poor customer service, but that wasn’t the case with Greenlight Guru Clinical.
Moran said that the quality of the support and customer service her team received (and is still receiving!) is second to none.
“Most of the time, after you sign a contract, the level of customer service goes down. But with Greenlight Guru Clinical, it didn’t. I had open access to their team, and I took advantage of it,” Moran said.
In fact, the team at Loop Medical saw a mirror image of their own dedication in the customer service they received. Which is a big part of why they’ll be sticking with Greenlight Guru Clinical as they move on to their pivotal study.
What’s next for Loop Medical?
The team at Loop is preparing for a pivotal clinical study where they will again be monitoring data collection remotely. Their next study is larger and more complex and both the CRO and study are located in Chicago. Following the study, Loop plans a regulatory submission to the FDA in 2024, with the expectation of getting the onflow to market in the US as soon as possible.
After the initial approvals, the overall goal for Loop is to provide a device that is compatible with any type of blood analysis required by a doctor. To do this, Loop will be exploring other volume capabilities and running more studies validating different tube types, such as serum gel, lithium heparin, etc. The mission of Loop Medical is to provide quality access to blood collection to anyone, anywhere.