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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 SMART-TRIAL’s EDC Platform.
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.
“Working with the previous EDC platform was a nightmare. Creating studies was very problematic and we spent a long time setting them up. More importantly, when we needed to export the data we had collected, it didn’t work. So, we had to manually input all data into Excel, which was extremely time consuming." – Barbara Simon, Lead Clinical Audiologist, Bernafon.
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:
Bernafon selected SMART-TRIAL EDC. 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.
Bernafon overcame all previous challenges with data management and have continued to use SMART-TRIAL 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:
“You don’t need to have an engineering degree or software degree to use it, the platform is very intuitive and easy to learn. We can easily access our data without a huge fuss, and it is now super easy and flexible for us to create each page of our eCRF.” - Barbara Simon, Lead Clinical Audiologist, Bernafon.