On-Demand Webinar

What the FDA’s shift to real-time clinical trials means for sponsors & CROs

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. Watch this session featuring Asha Mahesh, Nazim Khan, and Kathleen Fernandez-Colatrella, who are actively working with the FDA on pilot studies.

Whether you’re looking at early pilot frameworks or planning for production, this discussion covers 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

Data Officer

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.

What the FDA’s shift to real-time clinical trials means for sponsors & CROs

Featured speakers

Kathleen Fernandez-Colatrella

Asha Mahesh

Nazim Khan

Matt Tendler