PhaseV has launched the AI Conductor centralised platform designed to automate every stage in the clinical trial process from drafting protocols to submitting final reports.
The platform offers integrated data management and automated standardisation.
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It generates statistical code, analysis data model (ADaM) datasets, study data tabulation model (SDTM) mapping, and publication-ready reports for US Food and Drug Administration (FDA) submission while managing required trial documentation.
The enterprise-grade workspace centralises collaboration, providing real-time drafting of study components and optimisations through generative AI.
By connecting with internal standard operating procedures (SOPs), historical documents, and templates, it embeds regulatory logic into the workflow.
The platform supports inline commenting, granular permissions and version comparisons while maintaining an audit-ready change history.
AI Conductor operates as an orchestration layer across PhaseV’s vertical AI platform, coordinating modules such as ClinOps, trials, responses, and portfolio optimisers.
These tools help sponsors refine trial design, site selection and monitoring, identify target patient groups, and guide decision-making throughout the trial lifecycle.
Key capabilities include pre-trial authoring and collaboration, from synopsis through AI-driven protocol authoring, ensuring compliance at every stage.
It aligns statistical analysis planning (SAP) with ICH E9 standards and generates clinical data acquisition standards harmonisation (CDASH)-aligned case report forms (CRFs) from visit schedules.
The platform manages SDTM mapping, ADaM dataset generation, statistical code creation, as well as tables, listings, figures (TLFs), and clinical study reports for FDA submission.
By aligning regulatory requirements with sponsor data and workflows, PhaseV aims to ensure document accuracy and compliance from the outset.
PhaseV CEO and co-founder Raviv Pryluk said: “AI Conductor transforms clinical development from a series of disconnected manual tasks into a synchronised, intelligent process.
“Our AI doesn’t work in isolation. It draws from a wide knowledge base to deliver insights, enforce document consistency across the full trial, and ensure every study is submission-ready from the start.”
