Problem Section – The TMF Intake Bottleneck
Keeping the Trial Master File complete, accurate, and inspection-ready is critical—but doing it manually is slow, error-prone, and expensive. TMF teams are buried under:
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Delays in filing, inconsistent quality, late discovery of issues, and constant inspection anxiety.
Introducing the AI eTMF Agent
Intelligent Document Intake & Routing
- Drag-and-drop upload or bulk import from email, portals, and shared drives
- Automatically routes documents to the right TMF intake queue based on study, site, artifact type, and priority
- Flags urgent items (e.g., Urgent Project Document, serious safety documents) so nothing critical is missed
Intelligent Document Intake & Routing
Guided Metadata Prompting at Upload
How It Works – From Upload to eTMF
The AI eTMF Agent is a smart intake and quality assistant that sits in front of your eTMF. It automates document routing, classification,
metadata extraction, QC, and PII redaction—while keeping humans in control for final decisions.
Think of it as a dedicated digital TMF intake specialist that works 24/7, never gets tired, and documents everything it does.
Upload & Context
User uploads single or bulk documents and provides minimal context (e.g., study, site, document type hint).
Human Review (When Needed)
TMF Intake Agents see AI suggestions with confidence scores, quickly accept or adjust classification and metadata, and resolve QC flags.
Sync to eTMF
Once approved, the document is synced to your eTMF with complete, validated metadata and a full audit trail of AI and human actions.
AI Analysis & Draft Suggestions
The Agent runs OCR (if needed), classifies the file, extracts key metadata, checks quality, and identifies PII/PHI.
Redaction & Final QC
Documents requiring redaction or deeper QC are routed to specialized queues and processed accordingly.
Built for TMF & Clinical Operations Teams
TMF Managers
- Ensure TMF completeness and quality across all studies
Standardize intake and QC processes globally
- Reduce last-minute fire drills before inspections
Clinical Operations & Study Teams
- Faster document turnaround and filing
- Clear visibility into what’s missing, what’s pending, and what’s approved
- Confidence that critical docs are never stuck in inboxes
Quality & Compliance
- Transparent audit trail of AI and human decisions
- Configurable rules aligned with your SOPs and regulatory expectations
- Strong controls around PII/PHI handling and redaction
Measurable Outcomes
With AI eTMF Agent, customers typically aim for:
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50–70%
reduction in manual metadata entry time
30–50%
faster document intake and filing cycle times
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Significant reduction
in misfiled artifacts and missing metadata
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Stronger inspection readiness
with QC and redaction built into daily operations
Security, Auditability & Compliance
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Scale TMF Operations and Deliver Higher Sponsor Satisfaction
CROs manage high document volumes, aggressive timelines, and complex multi-sponsor workflows. The AI eTMF Agent helps CROs modernize TMF operations with automation that reduces cost, strengthens compliance, and improves delivery performance.
How CROs benefit:
- Accelerate startup and ongoing filing across multiple studies
- Standardize intake workflows regardless of sponsor or site variability
- Increase delivery speed with automated classification, metadata extraction, and QC
- Reduce TMF processing costs and minimize reliance on offshore teams
- Improve sponsor trust with real-time completeness and QC dashboards
- Reduce inspection findings with continuous surveillance and AI-driven quality checks
Outcomes for CROs:
- Faster cycle times
- Higher quality customer deliverables
- Stronger margins
- Competitive differentiation during RFPs and bid defense meetings
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Ensure Oversight, Quality, and Inspection Readiness Across All Studies
Sponsors face the challenge of overseeing multiple CROs, partners, and global sites—each with different processes and document quality levels. The AI eTMF Agent enables sponsors to centralize quality, streamline intake, and ensure consistency across the entire study portfolio.
How Sponsors benefit:
- Standardize filing and metadata requirements across CROs, sites, and regions
- Identify TMF issues earlier with automated QC and risk flags
- Improve oversight with real-time dashboards for completeness, timeliness, and quality
- Reduce study delays due to misfiled or missing artifacts
- Strengthen regulatory confidence with always-ready TMF health indicators
- Lower audit/inspection risk by ensuring continuous adherence to ALCOA+
Outcomes for Sponsors:
- Unified TMF operations
- Reduced CRO management overhead
- Fewer late-phase TMF surprises
- Faster study closure and regulatory submissions
