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Study Studio

eCOA builder with AI-assisted design, assessment scheduling, and translation management for clinical trial launch.

Solution by Medable
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Overview

Medable Studio is a SaaS-based study design and launch platform built for clinical research teams who need full control over the eCOA creation and configuration process. Combining a point-and-click interface with embedded Medable AI capabilities, Studio delivers what the company describes as the easiest and fastest path from study design to study launch — without the bottlenecks of traditional build processes.

Studio is designed for both full-service and self-service teams, standardizing the study creation workflow to reduce variation, minimize errors, and accelerate content velocity across the entire study team. Its AI-powered features enable assessment creation up to 35 times faster than conventional approaches, giving sponsors and CROs unprecedented transparency and control over the enterprise study launch process.

Core Modules and Capabilities

  • eCOA Builder with Medable AI: Create assessments, instruments, and diaries in seconds using GenAI smart prompts, with support for live preview, branching rules, and globalization features for translations.
  • Point-and-Click Schedule of Assessments Builder: Easily add assessments, instruments, and COAs to a patient schedule and configure standard visits, visit cycles, and visit types including site, remote, and unscheduled visits.
  • Translation Workbench: Manage all translations seamlessly in one place, editing only what needs to be sent for translation and importing results back to save time and resources, reducing translation bottlenecks.
  • Cross-Study Content Library: Store assessments, instruments, translations, and locales in a single system for easy reuse across studies, improving consistency and efficiency.

AI-Powered Study Build Features

  • Document Upload and Auto-Build: Upload any document format — PDF, chart, or graphic — and assessment screens are automatically generated in seconds, with the ability to further refine using the prompt feature or directly within Studio.
  • Easy Prompt Interface: Use natural language prompts to generate, edit, and refine assessment screens of varying complexity and logic in minutes.
  • Automated Optimization: Medable AI is engineered to automate and optimize the entire eCOA build experience, enhancing clinical trial launch efficiency.

Design and Workflow Advantages

  • Intuitive Point-and-Click Interface: The Studio interface standardizes design across the team, reducing unnecessary clicks, variations, and errors while enabling faster content creation and improved data collection consistency.
  • Live Previews and Validation: Preview, edit, and validate assessments, instruments, and translations in real time. Automatic testing catches errors early, cutting build time and reducing rounds of revisions.
  • Advanced Study Management: Studio accommodates complex protocols and supports last-minute changes across a broad range of study types, with fast access to edit assessments and patient schedules for review and approval.
  • Connected Data Collection: Supports devices, diaries, and sensors designed to fit into participants' everyday lives, with intuitive and automated workflows that remove manual entry and configuration time for sites and study teams.

Key Benefits for Study Teams

  • Take control of the eCOA process and eliminate roadblocks associated with traditional build approaches.
  • Collect better data and reduce the risk of error at every step of the study lifecycle.
  • Minimize the cost and time impact of protocol changes and maintain greater control over study timelines.

Medable Studio supports both full-service and self-service deployment models, ensuring teams are always on best-in-class technology. The platform's PI Summary Agent further extends its capabilities by maximizing investigator capacity and accelerating site workflows, reflecting Medable's broader commitment to reducing burden at research sites through AI-driven innovation.

Meta

Domain
Clinical Trial Management
Subdomain
Patient-Reported Outcomes (ePRO/eCOA) & Patient Engagement
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
Clinical
Target user(s)
Research ScientistQA / Regulatory AffairsClinical / Diagnostic Professional
Compliance standard(s)
21 CFR Part 11GxP
Tag(s)
Uses AI