InnoCon Medical Chooses Greenlight Guru Clinical for a Modern, Streamlined EDC Solution

InnoCon Medical is currently developing the UCon, a neurostimulator that provides electrical stimulation to relieve symptoms in people with overactive bladder and fecal incontinence. Living with incontinence can have a devastating impact on a person’s quality of life, potentially leading to social isolation, loss of employment, and psychological side effects.

When more conservative approaches to incontinence management, like lifestyle modifications and pelvic floor exercises, are unsuccessful, patients are often forced to turn to more expensive and invasive interventions. The team at InnoCon Medical is working to provide these patients with an alternative—a convenient and affordable solution for relieving the symptoms of incontinence via neurostimulation.

The Challenge: Missing data and a lack of insight into studies

The team at InnoCon is currently performing clinical investigations to obtain the clinical data they need to bring the UCon to market in Europe and start helping patients suffering from incontinence. 

The team performed one clinical investigation using paper, but they had problems with unfilled forms, which led to missing data. They also didn’t like the lack of oversight that paper forms forced on the team. Instead of getting real-time access to their data, they had to wait for the paper forms to be scanned and sent to them from the study sites. 

InnoCon Medical knew that to make the most of their next clinical investigations, they would need an EDC system to help them manage their data.

The Solution: Greenlight Guru Clinical

The team at InnoCon Medical looked at several EDC systems, but most of the options they evaluated were complicated, difficult to use, and typically built for pharmaceutical studies—not medical devices.
That ease of use was important to the team, not only for their own needs, but because they wanted something that the clinicians at their study sites could easily learn and use. Many EDC systems that are built for pharmaceutical studies include complicated features that require a high level of expertise to use correctly.

“I’ve tried using the REDCap system they use at hospitals. Compared to that, Greenlight Guru Clinical was very easy to get started with.” - Sarah Nygaard Jensen, Clinical Project Manager, InnoCon Medical

The Results: Happy sites, better data, and more insight

InnoCon Medical is currently running three feasibility studies for the UCon using Greenlight Guru Clinical. The team has noticed several benefits related to data collection and management since they began using the system.

Real-time insight and better completion

One of the first problems Greenlight Guru Clinical solved for InnoCon Medical was their issue with a lack of continuous visibility into their clinical studies.Using Greenlight Guru Clinical has also cut down on the frustration caused by missing data. When they were using paper, it was too easy for questions to go unanswered and the missing data wouldn’t be noticed until later. 

“If the site hasn’t answered all the questions in the form, then it’s marked incomplete in Greenlight Guru Clinical, which helps to make sure everything gets answered,” said Sarah Nygaard Jensen.

A great workflow leads to great site relationships

Sarah Nygaard Jensen stressed that InnoCon Medical put a premium on getting an EDC system that would be easy for them and their study sites to use. With Greenlight Guru Clinical, that’s exactly what they got.Communication and problem resolution have also improved now that InnoCon Medical is using Greenlight Guru Clinical. 

“It’s very helpful having the ‘query’ option. So if we see something that’s not quite right, we can make a query remotely instead of waiting until we can go to the site in person,” Sarah Nygaard Jensen said. “We don’t have to visit the sites as often because we have all these monitoring capabilities, and that’s been very helpful.”

What’s next for InnoCon Medical?

The team at InnoCon Medical will continue their work to improve the quality of life for those suffering from incontinence, and that work includes more clinical investigations in the near future. 

The UCon uses two types of electrodes—a Bar Electrode and a Patch Electrode—for dorsal genital nerve stimulation. InnoCon Medical has just received approval for a feasibility study on the Bar Electrode, and will also soon begin a pivotal study with the Patch Electrode.