Pi Health and GSK Sign Agreement for AI-Driven Clinical Trial Collaboration
Pi Health has entered into a collaboration with GSK to deliver fully outsourced clinical research services for a global Phase 2 oncology trial (undisclosed at this moment). The agreement is structured under a Master Clinical Services Outsourcing Agreement, with activities for the trial already underway. The collaboration aims to reduce inefficiencies in clinical research and accelerate the delivery of oncology treatments.
Pi Health will manage site selection, patient enrollment, study conduct, monitoring, and regulatory submissions through its proprietary Front-end Interoperable Capture System (FICS). FICS combines electronic data capture (EDC), clinical trial management systems (CTMS), trial master and investigator site files (TMF/ISF), and interactive response technology (IRT) into a single, unified platform.
The system is built to streamline workflows, improve communication between sponsors and sites, and deliver real-time, regulatory-grade data across the entire trial lifecycle. By embedding artificial intelligence to automate manual processes and maintain audit-ready records, Pi Health reports that FICS can reduce study timelines by up to 50% while sustaining data integrity.
Pi Health positions itself as an AI-native contract research organization with a global network of technology-enabled sites across five continents. Founded by physicians and staffed with former FDA and industry leaders, the company focuses on combining regulatory insight with technology-driven trial execution.
GSK is a global biopharmaceutical company specializing in specialty medicines, vaccines, and general medicines, with core focus areas in respiratory, immunology and inflammation, oncology, and HIV and infectious diseases. Its research and development efforts combine immunology with large-scale genetic datasets and advanced technologies to support drug and vaccine discovery. In 2024, GSK invested £6.4 billion in R&D, advancing two assets into Phase III trials, starting nine Phase I programs, and maintaining a pipeline of around 71 medicines and vaccines.
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Topic: AI in Bio
