Risklick, a University of Bern spin-off, has launched an artificial intelligence (AI)-based software, Protocol AI, for clinical trials of medical devices.
Protocol AI uses AI to speed up the development of clinical trials while cutting associated costs and risks. This fast-tracks access to new treatments, benefiting patients quickly with new and more affordable options.
The technology is intended to transform clinical trials, offering millions of patients faster access to life-saving devices around the world.
In April 2024, Risklick launched the software for the pharmaceutical industry.
According to Risklick, introducing a device typically takes three to seven years, with clinical investigations being the most time-consuming and expensive phase.
Each trial starts with creating a protocol crucial to the study’s success or failure. This protocol is developed after six months of work, where even small errors can lead to significant setbacks.
The medical device sector faces unique challenges compared to the pharmaceutical industry, including less standardisation, limited clinical trial experience, and growing regulatory demands.
Risklick founder and CEO Poorya Amini said: “We have developed a pioneering solution that reduces both the development time and costs of clinical trials, making it easier for patients to access new treatments.
“Our solution has already demonstrated a 50% reduction in study document development time for medicinal products, and we expect similar savings for medical devices with our tailored solution.
“Our innovative technology has the potential to improve the lives of millions of patients worldwide.”
The software uses Natural Language Processing (NLP) and Machine Learning (ML) to analyse clinical data, publications, and regulatory documents. This optimises study design and allows evidence-based decision-making.
By leveraging advanced Large Language Models (LLM), Protocol AI can automatically draft clinical trial protocols in minutes. This tool gives experts critical insights into the rapidly evolving medical device industry.
Additionally, Protocol AI helps experts significantly reduce protocol development time while maintaining quality, increasing the chances of clinical trial success.
The Swiss startup has already secured major partners, including Debiopharm, a biotech company, and ISS, a Swiss clinical research firm with expertise in medical devices, digital medicine, and In vitro diagnostics (IVD).
