Pi Health, a global health technology and clinical research company, has announced a strategic partnership with GSK to provide fully outsourced clinical research services for a Phase 2 oncology clinical trial. The collaboration, formalized through a Master Clinical Services Outsourcing Agreement, represents a significant step toward technology-driven clinical trial management aimed at accelerating cancer drug development.
Technology-Driven Clinical Trial Management
Pi Health will manage all aspects of the GSK clinical trial through its proprietary Front-end Interoperable Capture System (FICS) platform, integrated with an international network of clinical trial sites across the globe. The comprehensive service model encompasses site selection and activation, patient enrollment, study conduct, real-time monitoring, and regulatory submissions.
The FICS platform is an end-to-end clinical trial software platform with artificial intelligence capabilities that connects sites and sponsors to accelerate trials, enhance compliance, streamline data flow, and automate manual processes. According to Pi Health, the platform can make study conduct 50% faster while maintaining audit-ready data quality.
"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).
Regulatory-Grade Data Quality
Pi Health's technology and operational workflows are designed 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. This approach 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."
GSK's Strategic Partnership Decision
GSK selected Pi Health based on its integrated approach to clinical trial management and the team's strong background in drug development and regulation. "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.
The partnership aligns with GSK's priority of getting innovative medicines to people with cancer as quickly and safely as possible. "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," Rasheed added.
Company Background and Expertise
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. The team has reviewed more than 100 NDAs, BLAs, and PMAs, and over 1000 INDs, providing the company with unique insights into the challenges and solutions needed in clinical research.
The AI-native contract research organization is transforming global access to innovative medicines and clinical trials through its proprietary FICS platform, which is embedded with fine-tuned large language models and integrates full-service clinical research capabilities with a growing network of technology-enabled sites across five continents.
