TrialKey

TrialKey is an AI-powered SaaS platform purpose-built to automate and optimise clinical trial design and prediction. By leveraging advanced computational simulations, explainable AI, and predictive modelling, TrialKey delivers biostatistical validation at a speed and precision that traditional methods cannot match. The platform serves a broad range of life sciences stakeholders — including clinical trial researchers, trial sponsors, contract research organisations (CROs), large pharmaceutical companies, and biotechnology investors — helping them accelerate therapy development, reduce timelines, and improve trial outcomes.

TrialKey's proprietary dataset has been compiled over more than thirty years and encompasses over 520,000 curated clinical trial records and more than 1,500 predictive variables. Each trial is simulated up to 100,000 times to produce robust, reliable predictions. The platform achieves market-leading precision of over 92% in predicting primary endpoint completion (based on precision/recall metrics), and in Phase 2 trials with fewer than 100 studies, TrialKey achieved an AUC of approximately 0.78 versus approximately 0.73 in well-studied areas — demonstrating particular strength in rare conditions where capturing unique trial features is critical.

Core Platform Capabilities

• Optimal Trial Design Creation: Automates protocol creation by applying data-driven insights to define inclusion and exclusion criteria, endpoints, and site selection, reducing manual effort and human error.
• Trial Optimisation: Fine-tunes existing trial parameters to minimise risks, reduce timelines, and improve overall outcomes for ongoing studies.
• Outcome Prediction: Simulates a wide range of scenarios to forecast trial success and resource allocation with high confidence, enabling more informed decision-making before and during trials.
• Biostatistical Validation: Runs up to 100,000 simulations per trial against over 30 years of global trial data to deliver statistically rigorous, data-driven validation of trial designs.
• Unstructured Data Analysis: Applies advanced AI to unstructured data sources — including clinician notes, company filings, and press cuttings — to fill critical knowledge gaps and deliver real-world trial predictions.

Clinical Trial Design Report

• TrialKey offers a Clinical Trial Design Report that provides strategic recommendations on endpoints, inclusion and exclusion criteria, and site selection.
• Reports include benchmarks against competitor trials, giving sponsors and researchers a comprehensive view of the competitive landscape.
• Sample reports are available on request, and consultations can be booked to explore tailored recommendations.

Solutions by User Type

• Clinical Trial Researchers: Access biostatistical validation tools to simulate trials and optimise designs with precision.
• Trial Sponsors: Accelerate therapy development through TrialKey's tailored AI-driven recommendations, reducing time to market.
• Investors: Leverage AI-powered insights to identify opportunities for substantial capital appreciation in the biotech sector.

Pricing Tiers and Deployment

• Essential: Designed for small biotechs and early-phase studies requiring foundational AI-driven trial design support.
• Professional: Tailored for mid-tier CROs and sponsors managing multi-phase trials with more complex requirements.
• Enterprise: Built for large pharmaceutical companies running multi-country trials at scale.
• Plans are described as flexible, scalable, and tailored to the specific needs of each organisation.
• The platform is delivered as a SaaS solution, accessible via app login, with strategy sessions and demos available for prospective customers.

AI Methodology and Data Enrichment

• TrialKey's models are trained on data from over 520,000 clinical trials and incorporate more than 1,500 predictive features, enabling highly granular and accurate predictions.
• The platform combines machine learning, large language models (LLMs), natural language processing (NLP), and advanced econometric modelling to analyse both structured and unstructured data.
• AI-driven outputs are supervised by medical experts, ensuring that automated recommendations are grounded in clinical expertise and regulatory alignment.
• The platform is specifically designed to perform well in data-sparse environments, such as rare disease trials, where traditional models struggle.

Leadership and Research Team

• Saurabh Jain (Executive Chairman, Opyl ASX: OPL): Over 25 years of leadership in AI, SaaS, and digital transformation, with a track record of scaling high-growth technology companies across Australia and MENA.
• Damon Rasheed (Co-founder and AI Expert): Serial entrepreneur and economist with over 20 years of experience in machine learning, big data, and predictive analytics; developed TrialKey as an executive board member of Opyl.
• Tony Guoga (Strategic Advisor and Investor): Globally recognised investor and entrepreneur with experience spanning venture capital, fintech, blockchain, and AI; former Member of the European Parliament (2014–2019) with expertise in digital economy policy.
• Justin (Commercial Lead, US/UK/EMEA): Based in London, leading commercialisation of TrialKey's technology across key markets, engaging with sponsors, insurers, and CROs; previously involved in deploying ML, LLMs, and NLP within quantitative investment processes.
• Theo Voronov (Data Scientist): Expert in machine learning, statistical modelling, and AI-driven business optimisation, with prior experience at Atlassian and Westpac; drives TrialKey's advanced AI models using R, Python, and cloud platforms.
• Patricia Isabel Ramos, RND, MSc (Senior Clinical Researcher): Registered nutritionist-dietitian with expertise in clinical trials, metabolic health, and medical nutrition therapy; supports pharmaceutical research with a background spanning government science agencies and hospital clinical settings.

Mission and Vision

• TrialKey's mission is to make a meaningful difference in medicine by leveraging AI to refine recommendations, optimise trial designs, and pioneer innovative solutions addressing broader medical challenges.
• The company's vision is to be the leading global platform for clinical trial design optimisation and prediction, partnering with top CROs, pharmaceutical companies, biotechnology firms, and industry experts to accelerate medical innovation and bring treatments to market faster.
• TrialKey operates as part of Opyl (ASX: OPL) and has established official partnerships within the life sciences and clinical research ecosystem.

TrialKey represents a significant advancement in clinical trial intelligence, combining decades of curated trial data with cutting-edge AI to give researchers, sponsors, and investors the tools they need to design smarter trials, predict outcomes with greater confidence, and ultimately accelerate the development of life-changing therapies.