Pi Health, a global health technology and clinical research company, today announced a strategic collaboration with GSK to deliver fully outsourced clinical research services. The partnership aims to meaningfully improve the speed and efficiency of the clinical trial process. Under a newly executed Master Clinical Services Outsourcing Agreement, Pi Health has already initiated work on a global Phase II oncology clinical trial, marking the beginning of this collaboration.
Through this agreement, it will assume responsibility for end-to-end trial management. The company’s services will cover all aspects of trial operations, including site identification and activation, patient enrollment, study execution, real-time monitoring, and regulatory submissions. By adopting a technology-driven service model, it seeks to address longstanding inefficiencies that often delay drug development timelines.
Leveraging Technology to Accelerate Clinical Trials
At the core of Pi Health’s approach is its proprietary Front-end Interoperable Capture System (FICS) platform, an advanced end-to-end software system enhanced with artificial intelligence. FICS connects clinical trial sites and sponsors through a unified platform that facilitates seamless data exchange, streamlines regulatory compliance, and automates tasks that traditionally require manual intervention.
The system is integrated with a broad international network of clinical trial sites, allowing it to support trials at a global scale. According to the company, FICS can accelerate study conduct by as much as 50% while maintaining audit-ready, regulatory-grade data quality. The platform is designed to ensure that all trial data remain continuously inspection-ready, thereby eliminating the need for costly, resource-intensive reconciliation processes and external data management vendors.
By reducing bottlenecks in data flow and enhancing transparency across trial stakeholders, Pi Health believes FICS can fundamentally change how trials are executed — bringing faster results without compromising quality or patient safety.
Leadership Perspectives
“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 Geoffrey Kim, M.D., CEO and co-founder of Pi Health. Dr. Kim, a former Deputy Director of the FDA’s Oncology Center of Excellence, emphasized that the collaboration validates Pi Health’s mission to reimagine the clinical trial ecosystem. “Our technology provides the transparency and efficiency that senior leadership demands while delivering the data quality that regulators require,” he added.
Bobby Reddy, M.D., Chief Operating Officer and co-founder of Pi Health, echoed this optimism: “We are thrilled about what this agreement represents for global drug development. Collaborating with GSK to support its efforts in streamlining trial delivery aligns with our shared vision of making drug development more efficient and effective for patients around the world.”
From GSK’s perspective, the collaboration reflects confidence in Pi Health’s integrated approach to trial execution. Zeshaan Rasheed, M.D., Ph.D., Senior Vice President and Head of Oncology Clinical Development at GSK, commented: “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. 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.”
A Team Built for Impact
Pi Health’s foundation is deeply rooted in medicine and regulation. The company was established by physicians and has built a multidisciplinary team that includes experienced clinicians, principal investigators, and former leaders in pharma and biotech. The team also features former senior officials from the U.S. Food and Drug Administration (FDA), with extensive experience reviewing more than 100 New Drug Applications (NDAs), Biologics License Applications (BLAs), and Premarket Approvals (PMAs), as well as over 1,000 Investigational New Drug (IND) submissions.
This unique blend of clinical expertise, regulatory insight, and technological innovation positions Pi Health to address many of the structural challenges that slow clinical trials today. By combining operational excellence with its AI-powered FICS platform, Pi Health aims to deliver on its vision of transforming clinical research for the benefit of patients worldwide.
Looking Ahead
The collaboration with GSK marks a significant milestone for Pi Health as it demonstrates the scalability and global applicability of its model. With the initial Phase II oncology trial already underway, the partnership has the potential to accelerate the delivery of life-saving treatments in oncology and beyond.
As the clinical trial landscape grows increasingly complex, partnerships that bring together cutting-edge technology, operational expertise, and regulatory credibility will be critical to advancing drug development. For Pi Health and GSK, this collaboration represents not only an opportunity to streamline trial execution but also a step forward in ensuring that innovative medicines reach patients more quickly and safely.
About Pi Health
Pi Health is an AI-native contract research organization (CRO) transforming global access to innovative medicines and clinical trials. Powered by its proprietary FICS® platform—embedded with fine-tuned large language models—Pi Health integrates full-service clinical research capabilities with a growing network of technology-enabled sites across five continents. This unified approach delivers breakthrough efficiencies, cost savings, and perpetual regulatory-grade data quality for sponsors and sites alike. With its rapidly expanding global footprint, Pi Health is making clinical trial participation accessible to patients everywhere. To learn more, visit pihealth.ai.
