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Company description

Medable is a leading technology platform for AI-powered clinical development, purpose-built to accelerate every stage of the clinical trial lifecycle. The platform serves pharmaceutical companies, biotechs, and contract research organizations (CROs), offering a unified suite of tools that combines agentic AI, electronic clinical outcome assessments (eCOA), and decentralized clinical trial (DCT) solutions to streamline startup, enrollment, and study conduct — compressing timelines from years to days and months.

At the core of Medable's vision is a 1:1:1 ambition: one day to study start, one day to patient enrollment, and one year for study conduct. The platform unifies clinical systems, workflows, data, and clinical context, enabling intelligent and trusted action while reducing manual burden across clinical operations. Medable's AI is built with deep regulatory context — covering GxP compliance and global regulatory requirements — making it distinctly suited for clinical development in ways that general-purpose AI platforms are not.

Agentic AI Platform and Key Agents

• Agent Platform: Medable's Agent Platform is purpose-built for clinical development, providing agentic AI capabilities across the full trial lifecycle. It is designed to unify clinical systems and workflows and convert data into intelligent, auditable action.
• Agent Studio: Described as the industry's first agentic AI platform for clinical development, Agent Studio enables leading teams to build and deploy AI agents rapidly, with case studies showing trial build times reduced to a single business day.
• PI Summary Agent: Launched to reduce burden at research sites, the PI Summary Agent assists principal investigators with oversight and monitoring of eCOA data, maximizing investigator capacity and accelerating site workflows.
• Clinical Monitoring Agent: Provides a holistic, site-specific view of trial activity — including enrollments and screen failures — directly at login, replacing the need to track hundreds of emails and significantly improving site oversight for Clinical Research Associates.
• TMF Agent: Automates Trial Master File (TMF) processes, significantly improving quality and consistency while drastically reducing manual effort in document management. Built on Medable's Agent Studio.

eCOA and Participant Engagement Solutions

• Medable offers an agentified eCOA solution that brings AI-powered workflows to every stage of the trial, from build and deployment through study conduct and data review.
• The eCOA suite spans eConsent, sensors, provisioned devices, and BYOD (Bring Your Own Device), delivering a unified participant experience that reduces operational complexity across every touchpoint.
• The platform has demonstrated 90%+ eCOA participant adherence and near-perfect compliance across a 70+ site master protocol.
• Medable achieved 99% eCOA adherence in Japan, with first patient in (FPI) completed ahead of schedule across a complex regional rollout.
• AI-powered translation capabilities have reduced translation timelines by 43%, cutting time-to-go-live in half.

AI Governance, Compliance, and Data Integrity

• Always traceable: Every automated action is logged, explainable, and auditable end-to-end, ensuring full transparency across clinical operations.
• Human-in-the-loop: Critical decisions remain with the clinical team, ensuring full control is maintained and clinical judgment is amplified rather than replaced.
• Built-for-purpose compliance: Regulatory context — including GxP and global regulatory requirements — is embedded from day one, not retrofitted after deployment.
• The platform is built for global regulatory compliance and data integrity, supporting complex multi-regional and multi-site studies.

Industry Collaboration and Evidence Generation

• Medable launched the Innovation Evidence Workshop series in collaboration with the Tufts Center for the Study of Drug Development (Tufts CSDD), bringing together leaders from 20 pharmaceutical, biotech, and CRO organizations to address DCT impact, adoption, and best practices.
• The inaugural workshop featured representatives from the U.S. Food and Drug Administration, global pharmaceutical companies, leading CROs, Harvard MRCT, Tufts CSDD, and Medable.
• Medable's customer base includes top-10 pharmaceutical companies, as evidenced by testimonials from Clinical Research Associates at leading pharma organizations.

Medable continues to push the boundaries of what is possible in clinical development, combining purpose-built agentic AI with proven eCOA and DCT capabilities to help sponsors, CROs, and research sites run faster, more compliant, and more participant-centric trials at a global scale.

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Software attributed to Medable

• Agent StudioView
• eCOA+View
• Total ConsentView
• Study StudioView
• CRA AgentView
• TMF AgentView
• PI Summary and Review AgentView

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