PhaseV Trial Optimizer is an AI/ML-powered decision support platform designed to enhance the design and execution of Phase 1–3 clinical trials. By integrating multiple data sources, including sponsor-provided and external datasets, the platform enables biopharmaceutical companies and Contract Research Organizations (CROs) to navigate complex trade-offs such as cost, power, duration, probability of success, and adaptability. To date, Trial Optimizer has helped sponsors reduce patient recruitment and trial duration by up to 40%, cut development costs by as much as 50%, and increase the probability of success by over 30%. Key Features and Functionality: - Rapid Simulation Engine: Conducts millions of simulations within minutes to optimize trial designs, including fixed, adaptive, and Bayesian methodologies. - Causal-to-Design Integration: Utilizes insights from previous trials and real-world data to refine inclusion/exclusion criteria and inform development considerations. - Placebo Response Estimation: Models average placebo response rates by leveraging relevant study data and real-world evidence. - Multi-Stakeholder Collaboration: Designed for use across clinical operations, biostatistics, clinical development, and data science teams to promote joint decision-making. Primary Value and Problem Solved: PhaseV Trial Optimizer addresses the high failure rates and escalating costs associated with clinical trials by providing a data-driven, AI-enhanced platform that streamlines trial design and execution. By enabling rapid simulation and optimization of trial parameters, it reduces patient recruitment needs, shortens trial durations, and increases the likelihood of success, ultimately accelerating the delivery of new therapies to patients.