What the FDA’s shift to real-time clinical trials means for sponsors & CROs
September 24 | 9 AM PT / 12 PM ET | Duration: 1 hour
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The life sciences industry is witnessing a foundational shift as the FDA advances its proof-of-concept pilot for real-time clinical trial data flows. While it's starting small with phase two trials, the industry is steadily moving toward continuous, real-time data integration for clinical development.
For sponsors and CROs, the biggest challenge is figuring out how to set up these data pipelines and infrastructure to keep pace with changing regulatory expectations.
Join us for an interactive, Q&A-focused session featuring Asha Mahesh Nazim Khan, and clinical data experts from Paradigm Health, who are actively working with the FDA on pilot studies.
Whether you’re looking at early pilot frameworks or planning for production, this discussion will cover what it takes to build a modern, real-time data workflow. Attendees will learn:
- Inside the FDA pilot: Insights into how organizations are preparing for and executing the FDA’s real-time clinical trial data initiatives
- The strategic role of SCE: How a modern statistical computing environment bridges the gap between raw, continuous data flows and scalable, production-ready environments
- Operationalizing real-time data: Practical considerations and architectural requirements for setting up and managing sustainable, real-time data infrastructure
Featured speakers
Kathleen Fernandez-Colatrella
Founder and President
Kathleen Fernandez-Colatrella is a clinical research leader with 15+ years of experience driving R&D across leading pharmaceutical and biotech organizations. Her career has been defined by one mission: transforming clinical trials into faster, smarter, and more patient-centered process. As Founder & CEO of LINEA System, she built the company to solve one of the most pressing challenges in healthcare: how to identify and activate the right clinical trial sites with confidence and speed. The result is AcceleTrial, a clinical trial site intelligence and activation platform that gets sponsors to First Patient In in under four weeks, instead of months. Her goal is for AcceleTrial to become the platform every sponsor runs through before a trial starts, turning site identification from a guessing game into a fast and precise intentional effort, so patients don't have to wait years for a treatment that can improve their lives.
Asha Mahesh
Co-Founder
Asha Mahesh is a Data Science and Technology leader with 20+ years in life sciences, driving R&D and Commercial Operations to get treatments to patients faster. She builds the data foundations and AI products that make science actionable—most recently, Trustworthy AI whose reasoning is grounded in scientific and clinical knowledge. Her standard is consistent: everything must be reproducible and defensible. Data you can trace. Cohorts anyone can re-run. Packages a reviewer can sign. The measure of the work is simple—whether it shortens the distance between a discovery and the patient who needs it.
Nazim Khan
Clinical Operations Leader
Nazim Khan is a clinical development and operations leader with 15+ years of experience advancing global drug programs from early development through Phase IV. His career has focused on bridging clinical science, execution, and enterprise strategy to accelerate high-impact therapies across oncology, CNS, rare disease, and other therapeutic areas. He specializes in transforming portfolio strategy into inspection-ready execution, leading large-scale global trials and strategic alliances across pharma, biotech, and CRO partners. By combining deep regulatory expertise (FDA/EMA) with data-driven operations, he builds scalable frameworks that reduce development risk while driving quality and speed. His approach leverages AI-enabled tools, external innovation, and advanced analytics to modernize trial design and streamline decision-making, ensuring clinical development programs consistently deliver on their commitment to patients.
Matt Tendler
Product manager for life sciences
Currently leading Product Management for Domino Data Lab's Life Sciences division, Matt oversees product initiatives for the biopharmaceutical industry. Prior to joining Domino, Matt held senior product leadership roles at Medidata Solutions and ArisGlobal, where he architected Data Fabric and Analytics solutions, bringing more than ten analytics tools to market that advance clinical trial efficiency and safety signal detection capabilities across the industry. Throughout his career, Matt has successfully helped implement agile and quality practices across organizations of all sizes, from emerging medical device companies to global pharmaceutical enterprises.