Pathkey.AI (previously Opyl), the global leader in AI-driven biostatistical validation and an ASX-listed company (ASX: PKY), is transforming clinical trial designs through its advanced simulation platform, TrialKey. Tailored for Clinical Research Organisations (CROs), pharmaceutical companies, and trial sponsors, Pathkey enhances success probabilities across all phases of clinical research, delivering comprehensive global trial design solutions.

Key features include the TrialGen module, which offers data-backed recommendations on study type, enrolment numbers, inclusion/exclusion criteria, endpoints, and optimal trial durations. Pathkey’s simulation capabilities also refine intervention models, masking types, and resource allocation, reducing costly amendments and accelerating market entry, providing a competitive advantage in clinical research.

With market-leading accuracy, Pathkey’s platform achieves over 92% in forecasting trial completion. By simulating each trial 10,000 times, it delivers robust, data-driven biostatistical validation to optimise designs. The platform analyses extensive datasets from over 350,000 clinical trials and 1300+ variables, offering critical insights for strategic planning and decision-making, including competitor benchmarking and success probability distributions.

Globally applicable and scalable, Pathkey supports companies of all sizes, from small firms managing a few trials to large organisations running thousands. Its user-friendly design and comprehensive support empower clinicians, researchers, and investors to make informed decisions, streamline trial outcomes, and advance medical research.

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