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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.

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.

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.

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.

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

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Core Capabilities

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

    Practical TMF Business Cases for Machine Learning

    laptop user

    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.

    "Overall, Automate has helped us work more efficiently and is a valuable solution for any organization looking to improve TMF data quality and streamline processes.”

    -Associate Director, TMF Operations

    “I would recommend Automate to another CRO. Its ability to accurately extract multiple metadata fields has noticeably reduced manual effort and improved overall data quality. The tool integrates smoothly into existing processes and is user-friendly, making adoption easy for teams. Overall, Automate has helped us work more efficiently, which makes it a valuable solution for other organizations as well.”

    - Associate Director, TMF Operations, mid-sized CRO

    Trial Interactive eClinical Platform

    eTMF and TMF Solutions

    eTMF and TMF Solutions

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    Content Management

    Content Management

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    Trial Management

    Trial Management

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    Learning Management

    Learning Management

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    Request your free demo of TransPerfect Automate today!

    Request your free demo of TransPerfect Automate today!

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