TMF Agent

Medable's TMF Agent is an agentic document management solution purpose-built for clinical trial master file (TMF) operations. Designed for TMF operations teams, sponsors, and CROs managing high volumes of trial documentation, it automates the end-to-end process of document intake, classification, metadata extraction, and compliant filing — enabling teams to shift from manual execution to strategic oversight.

By continuously operating across studies, the eTMF Agent eliminates the time-consuming, error-prone work of manually checking, renaming, tagging, and uploading every trial document. The result is fewer backlogs, faster audit readiness, and significantly reduced operational burden on clinical teams.

Core Capabilities

• Automated document intake directly from inbox to eTMF, removing manual handoffs
• Intelligent document classification with confidence scoring so users can accept or adjust results
• Automated metadata extraction to ensure consistent, accurate tagging across all documents
• Compliant filing workflows designed to meet global regulatory requirements
• Multilingual support enabling operations at global scale
• Continuous document intake and organisation across multiple studies simultaneously

Oversight and Control

• Agents handle high-volume document work while teams retain review and approval authority
• Every agent action is subject to verification workflows and data quality checks before being surfaced to users
• Rigorous validation checkpoints and business logic guardrails operate within a controlled environment
• Real-time monitoring ensures accuracy, compliance, and auditability at every step
• Human involvement is recommended for higher-risk tasks, maintaining appropriate oversight

Audit Readiness and Traceability

• Every action is tracked with clear traceability, making documentation inspection-ready without additional effort
• All actions, prompts, responses, and connector events are logged within the Medable platform
• Once documents are filed in the target TMF system, that system's native audit trail records the final action
• Designed to comply with all major global regulations, including FDA 21 CFR Part 11, ICH E6 (R2), and GDPR

Measured Impact

• 60% time saved per TMF document for classification tasks
• Continuous document intake and organisation reduces backlogs and last-minute audit scrambles
• Teams are freed from manual execution to focus on higher-value oversight activities

TMF Agent is built to integrate with existing eTMF systems, augmenting current infrastructure by automating how documents are organised, reviewed, and submitted rather than requiring a full platform replacement. The solution operates within Medable's Agent Studio framework, providing a compliant, audit-ready foundation for clinical trial document management at scale.