Medable Launches The Industry’s First Agentic AI Platform and CRA Agent; Removes Bottlenecks in Clinical Development

PALO ALTO, Calif.--(BUSINESS WIRE)--Medable, the leading technology provider for clinical development, today launched Agent Studio: the industry’s first agentic AI platform purpose-built for life sciences. Agent Studio is a no-code agent-builder that enables clinical teams to quickly custom-configure AI agents. Medable also introduced CRA Agent, an out-of-the-box agent running on Agent Studio that is specifically designed for clinical trial monitoring. Both Agent Studio and CRA Agent will drive unprecedented efficiencies across the clinical development life cycle and remove bottlenecks hindering scientific advancement.

Despite decades of innovation, clinical development remains constrained by persistent operational inefficiencies that slow progress. New drugs spend about 45% of development time on white space, the unproductive time in trial phases. Agent Studio not only removes white space between phases but also the longstanding bottlenecks anchoring trial processes.

Medable’s new Agent Studio empowers teams to create purpose-fit agents that solve key clinical development bottlenecks to eliminate white space across complex trial workflows such as protocol development and trial planning and optimization.

“Agent Studio is more than just technology – it’s a catalyst to unleash greater human potential in life sciences,” said Dr. Michelle Longmire, CEO and co-founder of Medable. “It frees teams from the bottlenecks of legacy systems, accelerates trials, reduces costs, and ultimately helps bring medicines to patients faster. We believe this is a once-in-a-generation leap forward in how clinical research gets done.”

Agent Studio is an expansion of Medable’s award-winning platform that drives eCOA, decentralized trial execution, and AI‑driven study design, including the following key advantages:

• Maintains human-in-the-loop oversight to ensure transparency and control
• Aligns with life sciences standards by incorporating standard operation procedures, regulatory and validation requirements, and benchmarking against trusted sources
• Seamlessly integrates across life science systems (eCOA, Veeva EDC, IRT, CTMS) and enterprise platforms (such as Salesforce, Microsoft, Gmail)

Agent Studio is informed by Medable’s deep expertise in clinical research and shaped by insights from researchers, clinical trial operators, and regulators on the front lines of clinical development. It brings the industry closer to Medable’s “1:1:1” vision – one-day study start, one-day patient recruitment, and one-year study conduct – with the goal to get effective therapies to people faster.

CRA Agent, the first of Medable’s pre-built agents, aggregates and summarizes data across systems, supports human-in-the-loop oversight for critical areas, and automates routine monitoring and communication. With CRA Agent, clinical research associates are free to focus on what matters most.

“The inherent linear processes of clinical research cause delays at nearly every critical point of a trial,” concluded Tim Smith, Chief Technology Officer and co-founder of Medable. “Agent Studio, designed specifically for the inherent complexities of this industry, will solve longstanding problems and allow the industry to completely re-imagine drug development.”

Medable Agent Studio and CRA Agent are available now – see a live demo at DPharm (Sept 16-17, 2025) in Philadelphia at Medable Booth #300. Book a meeting here.

About Medable

Medable’s AI-powered clinical trials platform enhances speed, scale, and patient access in clinical research, accelerating medicines for thousands of conditions without treatment or cure. Awarded Best Digital Health Solution by the Galien Foundation, 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, and was listed for the second year in a row on the Inc. 5000 in 2024.