On September 24, 2025 Pi Health, a global health technology and clinical research company, reported it will provide fully outsourced clinical research services in a GSK clinical trial with the aim of significantly improving the time and efficiency of the clinical trial process (Press release, GlaxoSmithKline, SEP 24, 2025, View Source [SID1234656210]). Pi Health and GSK have executed a Master Clinical Services Outsourcing Agreement for the collaboration and have begun initial activities for a global Phase 2 oncology clinical trial.
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Pi Health will manage all aspects of this GSK clinical trial through a technology-driven service model, including site selection and activation, patient enrollment, study conduct, real-time monitoring and regulatory submissions.
Pi Health will leverage its Front-end Interoperable Capture System (FICS) platform — integrated with an international network of clinical trial sites across the globe — for the clinical trial. FICS is an end-to-end clinical trial software platform with artificial intelligence capabilities that enriches current systems by using a unified solution that connects sites and sponsors to accelerate trials, enhances compliance, streamlines data flow and automates manual processes.
The FICS platform can make study conduct 50% faster while maintaining audit-ready data quality. Pi Health’s technology and operational workflows are built to achieve regulatory-grade data capture throughout the lifecycle of trials, enabling perpetual, real-time readiness for regulatory reviews and eliminating the need for manual reconciliation and expensive third-party processing.
"By applying Pi Health’s technology and international reach to GSK’s global scale and expertise, we believe we can accelerate the development of vital treatments for patients in need of new therapies by making clinical trials faster and more efficient," said Pi Health CEO and co-founder Geoffrey Kim, M.D., former Deputy Director of the Oncology Center of Excellence at the Food and Drug Administration (FDA). "This collaboration validates our commitment to fundamentally reimagining how trials should be run. Our technology provides the transparency and efficiency that senior leadership demands while delivering the data quality that regulators require."
"We are thrilled about what this agreement represents for global drug development," said Bobby Reddy, M.D., Chief Operating Officer and co-founder of Pi Health. "We are optimistic about collaborating with GSK to support its efforts in streamlining clinical trial delivery, with our shared goal of developing medicines more efficiently for patients."
"Pi Health’s integrated approach to clinical trial management, and its team’s strong background in drug development and regulation, made them a natural choice," said Zeshaan Rasheed, M.D., Ph.D., Senior Vice President, Head of Oncology Clinical Development at GSK. "By removing inefficiencies that can slow progress in clinical trials, Pi Health is well positioned to help us focus on our main priority: getting innovative medicines to people with cancer as quickly and as safely as possible."
Pi Health was founded by physicians and has assembled a multidisciplinary team that includes highly experienced clinicians, principal investigators, former industry leaders with deep experience in pharma and biotech clinical development and operations, and former FDA leaders with extensive approval track records (>100 NDAs, BLAs, PMAs reviewed; >1000 INDs reviewed) — giving the company a unique window into the challenges and solutions needed in clinical research.