PhaseV Trial Optimizer

PhaseV Trial Optimizer is an AI/ML-powered decision support platform solution for optimizing the design of clinical trials, enabling biopharma companies and CROs to explore, evaluate, and optimize trial designs with confidence. Designed to navigate complex trade-offs such as cost, power, duration, probability of success, adaptability, and more, Trial Optimizer combines data-driven AI/ML capabilities to accelerate and enhance the design process.

At the Exploration Stage, users can evaluate expected trial outcomes within a fixed design framework, a static trial design with no adaptive elements, using PhaseV's simulation tools. The Exploration Stage enables users to define and visualize key trial parameters, including endpoints, recruitment strategies, and statistical assumptions, while leveraging embedded AI features to streamline trial setup. The AI-enabled trial setup can allow users to replicate existing designs using NCT references (when applicable), estimate average placebo response rates from external datasets, and identify suitable trial sites based on geographic preferences. At this stage, users can additionally apply PhaseV's causal ML capabilities to refine inclusion and exclusion criteria by uncovering patterns within proprietary or public datasets. Users can upgrade to the next stage ("Design and Optimization Stage") seamlessly to unlock more advanced design and optimization functionalities described below.

At the Design and Optimization Stage, PhaseV supports data-driven decision-making through rapid Monte Carlo simulations that generate visual summaries and key performance metrics. Users receive optimized trial design recommendations, covering sample size reduction, alpha allocation, and interim analysis timing generated by the platform's proprietary algorithms. Multiple design scenarios can be explored and compared, allowing teams to align strategies with their specific goals and constraints. Once finalized, trial protocols can be downloaded directly from the platform for implementation and stakeholder sharing.

The platform is designed for multi-stakeholder use, including ClinOps, Biostatistics, Clinical Development, data science, and more, to promote collaboration and joint decision-making within the platform.

While not supported via AWS Marketplace, Trial Optimizer can also integrate seamlessly with CROs and external systems via defined APIs and supports advanced users through containerized environments for custom analytics. To learn more about external API integrations and other bespoke offerings, contact PhaseV's Strategic Partnerships team at info@phasevtrials.com .