Risklick is a Swiss-based digital health company that specializes in AI-driven solutions for clinical trial protocol development. Risklick’s flagship product, Protocol AI, is the first AI-based platform designed to streamline and optimize the creation of clinical trial protocols and related study documents. The solution enables companies to shorten protocol development time by 50% while enabling compliant and data-driven trial design.

Traditionally, clinical protocols take up to 12 months to write, involve 5-20 contributors, and suffer from poor quality due to error-prone, manual processes. Protocol AI modernizes this by providing an intelligent, collaborative platform that enhances quality and efficiency.

Protocol AI delivers two key benefits: faster time to market and higher clinical trial success rates. In one instance, it helped a top 10 pharmaceutical company launch a product a year earlier – delivering substantial value. What sets Protocol AI apart is its fully integrated, digital-native platform. Unlike fragmented tools or basic AI add-ons in Word, it offers an end-to-end solution purpose-built to replace manual workflows and streamline the entire process.

Every clinical trial – whether observational or interventional – depends on a solid protocol. Risklick’s platform supports both pharma and medical device trials, with tailored solutions that address specific templates, regulations, and workflows.

Launched in 2025, Study Engager is a smart, intuitive tool powered by Protocol AI that helps sponsors create engaging, patient-friendly materials – like videos, questionnaires, and interactive AI agents – directly from study documents. It enables the seamless collection of patient feedback through publicly shareable questionnaires and anonymized reports. By bringing patients into the process early, from recruitment onward, Study Engager not only improves study design but empowers participants to become ambassadors of the trial.

Dr. Poorya Amini, founder and CEO of Risklick, has a background as a veterinarian and holds a PhD in pharmacology. After completing his studies, he worked as a clinical trial project manager at a CRO, where he gained firsthand experience with the challenges of trial management. Seeing the industry’s reliance on outdated tools and recognising the potential of AI to address these challenges, he was inspired to create Protocol AI and lead efforts to drive innovation in clinical trial protocol development.

DayOne spoke with Dr. Poorya Amini, CEO of Risklick and DayOne Accelerator Alumnus 2023/24, about his journey with the DayOne Accelerator and what the future holds for the company. This is what he shared.

DayOne proactively contacted us when their team was scouting potential candidates for their acceleration program. They provided us an overview of the program, explained its structure, objectives, and potential benefits, allowing us to gain a clear understanding of how the program aligned with our goals and could support our growth.

We don’t typically participate in competitions and programs to instead focus on customers and product development, but we joined the DayOne Accelerator because of its practical approach and distinct value. Unlike many programs that offer generic or repetitive content, DayOne tailors its program to each startup cohort and uniquely facilitates direct access to leading industry stakeholders. This access provides invaluable opportunities for validating concepts and obtaining critical feedback – resources that are often difficult for startups to secure independently.

Pharma’s complex environment demands close collaboration to develop solutions that truly fit their processes, rather than off-the-shelf products that only partially match their needs. Programs like the DayOne Accelerator facilitate these crucial partnerships by connecting startups with industry players, ensuring innovation reaches the market and remains sustainable for both sides.

Additionally, our cohort included highly relevant companies, which facilitated meaningful interactions – not only as potential partners but also connecting with peers facing similar challenges. This targeted focus on clinical trials fostered productive exchanges, such as discussing common issues like pricing strategies. Connecting with other startups in the same space provided important insights and opportunities for collaboration, making the experience particularly beneficial.

Looking ahead, our goal is to maintain our leadership in digital protocol development and to set the industry standard. We are actively partnering with a range of companies to build a truly end-to-end solution. Our goal is to avoid becoming just another isolated solution. Integration is key – partnerships not only create greater value for clients but also strengthen our position by making our product part of a broader, connected ecosystem.

We are expanding our solution both upstream and downstream. In clinical trials, the protocol is the foundation for all related documents, from informed consent forms to statistical and data management plans, and ultimately the clinical study report. Our system is designed to automatically reuse protocol content to generate these downstream documents, ensuring consistency, efficiency, and compliance across the entire process.