Bernafon’s Clinical Trial Data Management Journey from Excel to Greenlight Guru Clinical

For 75 years, Bernafon has been empowering people to hear and communicate better, with industry-leading hearing aid technology. Helping hearing-impaired people all over the world, Bernafon has developed a wide range of hearing instruments to accommodate the varying needs and preferences of patients.

The continuous development and approval of new and better hearing instruments requires a long range of clinical trials with varying trial designs. Since 2018, Bernafon has managed all clinical trials in Greenlight Guru Clinical (formerly SMART-TRIAL).

The Challenge:

Prior to 2018, Bernafon completed a number of clinical activities that primarily included small-scale internal tests. All data was handled in Excel, which meant a lot of time spent on collecting and managing the data.

In 2017, their first official clinical study saw the light of day. Due to the larger scale of this study and the need for regulation compliance, Bernafon decided to use an EDC platform – They decided to try out a free EDC software.

Unfortunately, the free EDC platform turned out to have significant limitations, which vastly increased the time spent on data management.

After running one trial with the free EDC platform, Bernafon decided to change.

They were looking for the following traits in a new EDC platform:

• Fast and easy implementation and training
• Simple and flexible eCRF creation
• Intuitive interface
• Easy export of data to statistical analysis software
• Secure data management with no risk of losing data

The Solution:

Bernafon selected Greenlight Guru Clinical. This enabled them to quickly set up optimal studies for their clinical trials and export data more or less directly into their statistical analysis software.

Results:

Bernafon overcame all previous challenges with clinical trial data management and have continued to use Greenlight Guru's EDC software for all clinical trials. They managed to reduce time spent on trial setup and management significantly while ensuring fully compliant data collection.

The three main improvements compared to their former solutions were:

• Significantly reduced time spent on study setup and management
• Little to zero time spent on data export
• Easy handover to other employees due to easy and intuitive platform