Medable Agent Studio and eCOA Clinical Trial Platform

Medable is a clinical trial technology company based in Palo Alto, California, launched by Dr. Michelle Longmire. It builds software that helps pharmaceutical sponsors, CROs and research sites run clinical studies with less manual work, covering patient data collection, consent and remote participation, and now AI agents for clinical operations.

The Medable platform puts eCOA and ePRO, Total Consent eConsent, TeleVisit, connected devices and AI agents behind one login. Study Studio is a no-code builder for configuring studies, and Agent Studio lets teams configure agents that run autonomously or with a human in the loop. Pre-built agents include a Clinical Monitoring (CRA) Agent, an eTMF Management Agent, a PI Summary and Review Agent and a Digital Data Flow Agent. The platform reports reach in 80+ countries and 120+ locales with 400+ validated instruments.

• eCOA and ePRO: electronic outcome assessments with 400+ validated instruments.
• Total Consent: electronic informed consent for participants and caregivers.
• Study Studio: no-code visual builder with reusable study components.
• Agent Studio: framework to configure AI agents with verification and audit trails.
• Pre-built agents: clinical monitoring, eTMF filing, PI review and protocol digital data flow.
• Connectors: 30+ validated connectors to EDC, CTMS, TMF, IRT, Veeva, Oracle and Medidata.

CROs operating in Vietnam can run Vietnamese-language eCOA and eConsent for multinational sponsor studies. Hospital clinical trial centres can reduce monitoring workload with the clinical monitoring agent. Pharmaceutical firms can digitise protocols and trial master files for faster study start-up.

The company states studies that took 16-20 weeks to build can go live in 4-6 weeks, with builds up to 35x faster using Studio and AI. A Tufts CSDD analysis cited by Medable reports up to 21 million USD net value per drug development program from its clinical monitoring agent. Agents keep full audit trails and human oversight for regulated work. One platform reduces the number of separate vendors for eCOA, consent and devices.

Sponsors are moving from document-based trial operations to digital data flow and AI agents, with regulators such as the FDA promoting more real-time clinical trials. Southeast Asia, including Vietnam, is attracting more multi-country studies, which raises demand for multilingual eCOA and eConsent that meet 21 CFR Part 11 and ICH GCP.

Headquartered in Palo Alto, California; founded by Dr. Michelle Longmire. Recognised as Everest Group Leader for eCOA (2025), Everest Group Trailblazer (2024), Prix Galien UK Best Digital Platform (2024) and Prix Galien US Best Digital Platform (2023). Launched Agent Studio in 2025 and the TMF Agent in January 2026.