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Agent Studio

AI agents for clinical trials that automate manual work, integrate across clinical systems, and maintain human oversight while ensuring GxP and regulatory compliance.

Solution by Medable
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Overview

Agent Studio, developed by Medable, is a no-code agentic AI platform purpose-built for clinical trials. Designed for sponsors and CROs, it enables teams to design, deploy, and scale AI agents that automate manual work, remove bottlenecks, and accelerate trial outcomes across the full clinical development lifecycle. Agent Studio is grounded in life sciences regulatory standards including GxP, ICH, HIPAA, GDPR, and CDISC, making it suitable for the rigorous demands of clinical development.

The platform addresses a critical challenge in modern clinical trials: the growing complexity of studies has pushed human-only clinical development to its limits, resulting in longer drug development timelines and significant delays for patients. Agent Studio tackles this by leveraging agentic AI — autonomous, goal-driven systems that can reason, plan, and act — to eliminate unproductive "white space" caused by manual, sequential processes and fragmented data systems.

Core Platform Capabilities

  • No-code environment allowing teams to quickly configure and deploy agents tailored to specific clinical development needs
  • Support for both ready-to-go agent solutions and fully bespoke builds
  • Human-in-the-loop oversight, enabling teams to define how much control agents have and aligning automation with existing workflows
  • Alignment with life sciences standards by incorporating SOPs, regulatory and validation requirements, and benchmarking against trusted sources
  • Seamless integration with 13+ clinical and enterprise systems, including eCOA, Veeva EDC, IRT, and CTMS platforms
  • Real-time data flow across connected systems, eliminating manual data stitching and enabling faster decision-making

Trustworthiness and Data Quality

  • AI models are selected and fine-tuned specifically for life sciences, trained on high-quality, domain-relevant data to ensure understanding of regulatory requirements and clinical context
  • Agents operate within a controlled environment featuring rigorous validation checkpoints and business logic guardrails
  • Real-time monitoring ensures every recommendation is subject to verification workflows and data quality checks before being surfaced to users
  • Full auditability and compliance are maintained throughout the agentic recommendation process

Benefits of AI Agents for Clinical Trials

  • Automates repetitive tasks across trial workflows such as protocol design, patient recruitment, site coordination, and regulatory documentation
  • Adapts to new information and proactively orchestrates tasks to keep studies on track and compliant
  • Reduces human error and improves consistency across global trial sites
  • Enables more patient-centric approaches by improving communication and engagement
  • Supports scaling of complex global trials with fewer resources

Featured Agent: CRA Agent

  • Unifies data from across clinical systems, automatically surfacing insights and risks for clinical research associates (CRAs)
  • Eliminates the need for monitors to log into multiple platforms by consolidating information in one place
  • Handles routine monitoring tasks autonomously while keeping humans in the loop for critical safety oversight
  • Reduces technology burden and accelerates study timelines
  • Empowers CRAs to focus on data quality, patient safety, and site relationships

Agent Studio is built to integrate seamlessly into existing life sciences technology ecosystems, connecting with both clinical platforms and enterprise systems to enable real-time data flow. Its compliance-first architecture ensures that all automation operates within the regulatory frameworks required for clinical development, making it a robust solution for organizations seeking to modernize and accelerate their trial operations.

Meta

Domain
Clinical Trial Management
Subdomain
Clinical Data Review & Monitoring
Software type(s)
AI Agent
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
Clinical
Target user(s)
Research ScientistClinical / Diagnostic ProfessionalIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GDPRGxPHIPAAICH
Tag(s)
Uses AI