World Leader in Regenerating Damaged Human Tissues Uses Greenlight Guru Clinical

On a mission to become the world leader in tissue regeneration by sustainably harnessing nature’s own remedies, Kerecis is pioneering the use of fish skin and fatty acids for tissue regeneration. Kerecis has developed a unique use of the skin from the Atlantic Cod which resides in the deep, cold, and clean waters around Iceland.

The processed fish-skin grafts are used to vastly improve healing of acute, chronic, and burn wounds. The intact fish-skin graft significantly reduces time to heal compared to standard-of-care treatment, while also minimizing scarring and improving function outcomes. Thousands of patients have already been treated, or are in treatment, with fish skin, and results from ongoing clinical studies show extremely promising results compared to standard of care.

The Challenge

Kerecis is running several national randomized, controlled trials.

A crucial point of the data gathering is to include images to ensure that potential application errors are discovered quickly via photo reviews, and to document the wound healing development.

Additionally, Kerecis needs to run the study from Iceland, but with outpatient clinics located in four countries across Europe. This requires a digital solution to avoid weekly visits to all clinics and manual data input.

Kerecis has also conducted a similar study where data collection was paper-based. This caused several complications such as:

• Time-consuming manual data input and calculations
• Low recruitment rate
• Late discovery of application errors and missing data
• No automatic translation
• Lack of oversight

The Solution

Kerecis selected Greenlight Guru's EDC software to overcome the potential data-gathering challenges of the upcoming clinical studies. Along with the Greenlight Guru Clinical's eCRF module, Kerecis benefitted from our automatic translation Add-On and Custom Dashboards Add-on.

Results

With Greenlight Guru Clinical, Kerecis managed to run the trial in four countries from Iceland and limit in-person follow-ups and site visits to every 6 months rather than every month. This option became crucial for running the trial amidst the COVID-19 pandemic where travel was limited and access to hospital facilities was off-limits for anyone else than healthcare staff.

Greenlight Guru Clinical supports image-as-an-answer out of the box, so Kerecis now has real-time data monitoring and can ensure correct device application via photo reviews, as well as monitor if weekly visits are performed as scheduled.

The three main improvements compared to Kerecis’ former solutions were:

• No more manual data input and calculations thanks to automatic data gathering and calculations in Greenlight Guru Clinical
• Real-time data overview and wound development dashboards for all centers and patients
• Full data-compliance in both US and Europe