New agent supports digital infrastructure needed for FDA’s emerging real-time clinical trial model

PALO ALTO, Calif.: Medable Inc., the leading technology platform for agentic clinical development, today announced its Digital Data Flow (DDF) Agent, which automatically transforms static clinical trial protocols into structured, machine-readable data that can be continuously used across the clinical development lifecycle.

Traditionally, clinical trial protocols are static documents that require extensive manual interpretation and re-creation across many downstream systems. Medable’s DDF Agent converts protocol information into a CDISC USDM 4.0, standardized, structured JSON data format, which is foundational for automated and dynamic readiness and adaptivity throughout a clinical trial. For example, using Medable’s DDF Agent, trial sponsors can automatically generate their electronic clinical outcomes assessments (eCOAs) in minutes, while maintaining alignment with the source protocol and any subsequent amendments.

As the industry moves toward more adaptive and real-time data clinical trial models, Medable’s DDF Agent helps establish the infrastructure needed for continuous protocol evolution. Changes made to the protocol after approval can automatically propagate across connected documents, workflows, and systems, reducing operational burden and helping organizations respond more rapidly to emerging study insights.

This approach aligns with the U.S. Food and Drug Administration’s vision for real-time clinical trials, where ongoing data review becomes standard practice. In such an environment, maintaining consistency across study documentation and operational systems will require a digital, machine-readable foundation rather than traditional, document-based processes. Medable's DDF Agent represents an important step toward enabling that future.

“The FDA’s move toward real-time clinical trials makes clear that the industry can no longer rely on static documents and manual handoffs to support modern study execution,” said Jessica Dolfi, Medable Senior Vice President of Solution Consulting. “Medable’s DDF Agent helps create the machine-readable foundation needed to keep protocols, downstream systems, and operational workflows continuously aligned. That is essential for a future in which study data, endpoints, and safety signals must move with greater speed, consistency, and traceability to support real-time trial execution and responsiveness.”

Medable is agentifying the clinical development lifecycle, from protocol initiation to study close-out with Medable Agent Studio – a purpose-built agentic AI platform for clinical development that enables sponsors and CROs to deploy AI agents across clinical workflows. The platform combines no-code agent creation, human-in-the-loop oversight, GxP-ready compliance controls, a clinical data ontology layer, built-in AI governance, and Model Context Protocol connectors across clinical and enterprise systems to automate operational work while maintaining transparency, auditability, and regulatory alignment. And Medable’s Agentic Accelerator Program with onboarding, integration support, and change management allows customers to gain value from AI agents on day one.

Dig into the world of DDF further in this new blog, or learn more about Medable’s DDF Agent here.

About Medable

Medable is on a mission to get effective therapies to people faster. Its agentic clinical trials platform enhances speed, scale, and patient access in clinical research, accelerating medicines for thousands of conditions without treatment or cure. Awarded Leader in eCOA by Everest Group, Medable’s platform has been deployed in nearly 400 trials in 70 countries and 120 languages, serving more than one million patients globally. Medable is a privately held, venture-backed company headquartered in Palo Alto, California. Learn more at medable.com.

Fonte: Business Wire