Melbourne, Australia – Opyl Limited (ASX: OPL or “the Company”) is excited to announce the launch of ‘Trial Gen’ by TrialKey, an innovative module tool that leverages generative artificial intelligence to design clinical trial protocols. This new product represents a significant enhancement to our existing TrialKey platform, offering market-leading solutions that drive efficiency and success in the clinical research industry.

Key Features and Benefits of Trial Gen
AI-Powered Protocol Design for Enhanced Success: Trial Gen employs cutting-edge AI technology, trained on real-world data from over 350,000 clinical trials. This extensive dataset enables the tool to provide highly accurate and effective protocol designs tailored to the unique needs of each trial.
Optimising Key Trial Characteristics: Trial Gen optimises crucial trial characteristics to ensure the best possible outcomes, including:
- Choice of Endpoints: Identifying the most relevant and impactful endpoints.
- Inclusion/Exclusion Criteria: Defining precise criteria to select the right patient population.
- Choice of Partners: Selecting optimal countries, sites, principal investigators, CROs, and other collaborators.
- Detailed Protocol Decisions: Making informed decisions on patient numbers, masking, trial arms, and intervention models.
- Real-World Constraints: Allowing users to select alternatives based on constraints such as patient levels related to budgets and observe how estimated success rates change.

Process Automation and Cost Savings: One of the key advantages of Trial Gen is its ability to automate the clinical trial design process. The tool’s output can be directly used to create a Clinical Study Protocol (CSP), a critical document for trial approval. By automating this process, Trial Gen significantly reduces both time and expenses, providing substantial value to potential customers.
Scalable Solutions for All Clinical Research Stakeholders
Trial Gen is designed with a scalable business model, catering to a wide range of clients, including pharmaceutical companies, biopharmaceutical firms, and Contract Research Organisations (CROs). Clients can either utilise the tool independently or opt for additional consultancy services provided by TrialKey’s team of experts.
Versatile and Comprehensive Support
The tool’s output can be used to design a trial from scratch or serve as an additional decision-making resource for ongoing research. Trial Gen supports the creation of new protocols or enhances those that are already registered, covering all trial phases and intervention types, including drugs, devices, and other modalities.
Pricing Model
TrialKey’s pricing strategy for Trial Gen is designed to drive growth and shareholder value by accommodating the diverse needs of our clients. For smaller users, we offer an ad hoc pricing model, allowing them to design individual trials on a pay-per-use basis. For larger clients, such as pharmaceutical companies and CROs, we offer a subscription-based pricing model, ensuring predictable and recurring revenue streams.
Conclusion
The launch of Trial Gen represents a significant milestone in our mission to revolutionise clinical trial design and management. By providing scalable, AI-powered solutions, Trial Gen enhances the efficiency and success of clinical trials, benefiting pharmaceutical companies and clinical research organisations worldwide.



