Swiss startup Risklick launches AI-based software for medical device clinical trials

Protocol AI accelerates clinical trial development and patient access to medical devices

BERN, Switzerland , Jan. 22, 2025 /PRNewswire/ -- Risklick, a spin-off from the University of Bern, has launched its latest product, Protocol AI, for medical devices. Protocol AI is the first software of its kind and marks a turning point in the medical device industry. It uses artificial intelligence to accelerate the development of clinical trials while drastically reducing associated costs and risks. This accelerated timeline benefits patients, granting them quicker access to new treatments—potentially at a lower cost. This innovative technology has demonstrated its potential to revolutionize clinical trials for medical products and is now ready to provide millions of patients with faster access to life-saving medical devices worldwide. 

Bringing a medical device to market typically takes 3 to 7 years, with clinical investigations being the most time-consuming and costly phase. Every clinical trial begins with the development of a protocol, which serves as the cornerstone of the study and determines the trial's success or failure. Developing a protocol requires an average of six months of intensive work, where even minor errors can result in serious consequences for the clinical trial. 

Compared to the pharmaceutical industry, the medical device sector faces less standardization and has less clinical trial experience, coupled with growing regulatory demands that make clinical trial protocol development even more complex. These challenges significantly affect the availability, cost, and success rates of new devices, ultimately influencing patients' access to innovative solutions. 

AI-based software gives patients faster access to new medical devices 

To address these challenges, the spin-off from the University of Bern, Risklick, has developed Protocol AI. "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," says Poorya Amini, founder and CEO of Risklick. 

Protocol AI is the first groundbreaking software of its kind, utilizing Natural Language Processing (NLP) and Machine Learning (ML) technologies to analyze existing clinical data, publications, and regulatory documents, thereby optimizing the study design. Protocol AI enables evidence-based decision-making and the automatic drafting of clinical trial protocols within minutes, utilizing cutting-edge Large Language Models (LLM). This provides experts with vital parameters in the world of medical devices, which is in rapid and permanent evolution. 

Protocol AI allows experts to drastically reduce the development time of protocols while ensuring quality, as well as increasing the chances of success for the clinical trial, and is thus paving the way for medical innovation. Protocol AI promises to revolutionize the field of clinical trials and ultimately improve the lives of millions of patients worldwide. 

With Debiopharm, a leading biotechnology company in French-speaking Switzerland, ISS AG, Integrated Scientific Services, a Swiss clinical research company with expertise in medical devices, digital medicine, and IVD, Risklick has already attracted major players from both the pharmaceutical and medical device industries as partners. 

Images and further information: 

Contact:

Dr. Poorya Amini
CEO & Founder
Risklick AG
Spitalackerstrasse 26
CH-3013 Bern, Switzerland
Tel: +41 78 781 41 35
poorya.amini@risklick.ch
www.risklick.ch 

Images download: www.risklick.ch

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