Validated, GxP-centric AI for TMF record processing

TransPerfect Automate

TransPerfect Automate is a purpose-built artificial intelligence (AI) platform for Trial Master File (TMF) operations. It classifies records, extracts metadata, and runs completeness and quality checks directly inside your eTMF.

This life sciences AI solution operates in a validated, locked-state configuration designed for regulated environments. The result is faster document handling and an inspection-ready TMF without disruption to established ClinOps workflows.

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Automate by the numbers

Performance across TMF record types, drawn from production deployments

1079

Record types classified automatically (CDISC reference model)

70 %

Reduction in document handling time

200 %

Increase in document processing efficiency

80 %

Documents processed error-free

35 +

Metadata fields extracted per record

Simplify TMF Management with AI

TransPerfect Automate is a powerful AI solution that eliminates the manual process of classifying records to the TMF Index — reducing misfilings and driving automation across TMF management.

Automated workflows

Automate allows for controlled TMF workflows that move records through classification, review, and filing without manual handoffs. The confidence threshold enables high-confidence records to skip manual indexing completely, while lower-confidence records route to human review.

Automatic metadata extraction and coding

Automate extracts and codes over 35 metadata fields per document, including site, country, investigator, study, dates, and protocol number. The document type identification and metadata configuration are automatically matched to each record type.

Trained on the CDISC reference model

Automate is pre-trained on the CDISC reference model, which includes over 1,000 record types at the sub-artifact level. It covers approximately 100% of typical TMF structures out of the box, with no additional training required.

Language-independent

Automate leverages TransPerfect's experience in global languages. It operates as language-independent, easily processing records across more than 40 languages.

Core Capabilities

Classification & Metadata Extraction Confidence Scoring & Quality Control Validated, Locked-State & Continuous Compliance Human-in-the-Loop Governance AI Flags

Classification & Metadata Extraction

Automate is pre-trained on over 1,000 record types using the CDISC reference model. It classifies at the sub-artifact level and extracts 35+ metadata fields per record — with no additional training required. Processing is language-independent across 40+ languages and covers approximately 100% of typical TMF structures out of the box.

Confidence Scoring & Quality Control

Every record receives a confidence score with a rationale for its classification. Configurable thresholds allow high-confidence records to auto-progress while lower-confidence or ambiguous records (such as correspondence) route to human review. A Quality Score is generated per record type based on AI versus human validation.

Cross-Document Checks enable teams to detect inconsistencies, gaps, version conflicts, and missing dependencies across related TMF records, not just within a single file. These AI-enabled Mock-Inspection Readiness checks are designed to provide always-available gap assessment checks.

Validated, Locked-State & Continuous Compliance

The model version, prompts, thresholds, and mapping are fixed and version-controlled, with a configuration fingerprint recorded in the audit trail for every processed document. There is no self-learning in production — all updates flow through formal change control and revalidation, supporting 21 CFR Part 11, EU Annex 11, and GAMP 5 validation principles.

Trial Interactive’s roadmap advances toward Continuous Compliance powered by VirtualData.io. This function will identify mission-critical gaps in real time, analyze trends, provide predictions, and draft follow-ups.

Human-in-the-Loop Governance

TMF oversight is configurable to your risk tolerance. Reviewer corrections trigger a feedback loop that reprocesses and revalidates against content and rules, and the full audit trail distinguishes metadata populated by Automate from metadata entered by a person. Users can review, override, and validate AI outputs at any step.

AI Flags

TransPerfect will apply intelligent AI Flags to transform clinical document review from a manual, reactive process into a fast, proactive quality workflow. This capability analyzes documents during ingestion, then flags quality concerns within the document experience for review, dismissal, confirmation, or query creation. It identifies missing dates or signatures, incomplete or illegible pages, draft content, version integrity risks, PII/PHI exposure, and other ALCOA++ alignment issues.

It's designed with configurable rules, severity levels, confidence-driven analysis, auditability, and scorecards. The extensive integration into eTMF workflows helps sponsors and CROs identify quality risks earlier, accelerate QC, and strengthen inspection readiness at scale.

Building more efficient processes

Automate embeds directly into your eTMF system — including Veeva Vault Clinical — via APIs and middleware. That means your team never needs to log into separate applications.

1. Ingest

A record arrives in the TMF via inbox, upload, integration, or email

2. Trigger

Automate detects new records and initiates processing

3. Process

Classification, confidence quality and scoring, and metadata extraction are completed

4. Return

Results map automatically to the configured TMF fields

5. Route

The record auto-progresses, goes to QC review, or enters a review queue based on your thresholds

Streamlining eTMF Document Review

See how CSL Behring is replacing manual eTMF review with real-time, built-in automation. Download Case Study

Streamlining eTMF Document Review

Download the Case Study
Practical TMF Business Cases for Machine Learning

Practical TMF Business Cases for Machine Learning

TransPerfect Automate puts clinical AI to work on the record tasks that slow TMF teams down:

  • Record Classification: Identify and route documents to the correct TMF location automatically
  • Document Redaction: Flag and protect sensitive information at scale
  • Record Quality: Surface incomplete, misfiled, or low quality records before they become inspection findings
  • Inspection Readiness: Maintain consistent, complete, audit-ready metadata throughout the trial

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Why Automate

Validated GxP AI, not a general purpose model

Automate is deployed inside a HITRUST-certified hosting environment and operates under a validated system lifecycle. Many newer AI tools are not yet operating in validated, regulated environments — a baseline expectation for most sponsors and CROs.

Built for TMF, not adapted to it

Automate is purpose-built for TMF workflows: the CDISC reference model, eTMF taxonomy, metadata relationships, and regulatory and quality document types. This domain focus consistently outperforms generic document AI on TMF content.

Proven in production

Automate has been running in production for close to two years, supporting biotechs on real TMF workflows, operational performance data, real-world edge-case handling, and proven scalability into thousands of documents per hour.

Talk to our experts to learn more

Learn More ›

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