TrialKey

TrialKey is an AI-powered SaaS platform designed to automate and optimise clinical trial design for biotechs, contract research organisations (CROs), trial sponsors, and investors. By combining advanced computational simulations, explainable AI, and predictive modelling, TrialKey delivers biostatistical validation with a speed and precision that traditional methods cannot match — providing the fastest, most reliable path to optimised trial success.

The platform is trained on data from over 520,000 curated clinical trials spanning more than 30 years, incorporating 1,500+ predictive variables and advanced AI analysis of unstructured data sources such as clinician notes, company filings, and press cuttings. Each trial is simulated up to 100,000 times to ensure robust, data-driven predictions, and the platform achieves market-leading precision of over 92% in predicting primary endpoint completion.

Core Solution Capabilities

• Create Optimal Trial Designs: Automates protocol creation by applying data-driven insights to define inclusion and exclusion criteria, endpoints, and site selection.
• Optimise Existing Trials: Fine-tunes trial parameters to minimise risks, reduce timelines, and improve overall outcomes.
• Predict Outcomes: Simulates a wide range of scenarios to forecast trial success and resource allocation with high confidence.

Data Enrichment and Predictive Performance

• Leverages a proprietary dataset compiled over thirty years, including 520,000 curated trial records and 1,500+ predictive features.
• Applies AI detective work on unstructured data — including clinician notes, company filings, and press cuttings — to fill critical knowledge gaps.
• Delivers robust real-world trial predictions even in data-sparse environments; 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.
• Demonstrates particular strength in capturing unique trial features in rare conditions, where even modest efficacy signals can drive success.

Who TrialKey Serves

• Clinical Trial Researchers: Access biostatistical validation tools to simulate trials and optimise designs.
• Trial Sponsors: Accelerate therapy development with tailored AI-driven recommendations.
• Investors: Leverage AI-powered insights for capital appreciation opportunities in the biotech sector.

Plans and Reporting

• Essential: Designed for small biotechs and early-phase studies.
• Professional: Suited to mid-tier CROs and sponsors managing multi-phase trials.
• Enterprise: Built for large pharma organisations running multi-country trials.
• A Clinical Trial Design Report is available, offering strategic recommendations on endpoints, inclusion/exclusion criteria, site selection, and benchmarks against competitor trials.

TrialKey's AI and machine learning capabilities are supervised by medical experts, ensuring that automated insights remain clinically grounded and regulatory-aligned. The platform is scalable and flexible, with tiered plans tailored to organisations of all sizes across the clinical trial ecosystem.