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Case Study
CSL Behring Streamlines eTMF Document Review with TransPerfect Automate
About CSL Behring
CSL Behring is a global biotherapeutics leader headquartered in Pennsylvania. The company discovers, develops, and delivers plasma-derived and recombinant therapies for people living with rare and serious diseases across the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. It operates in more than 30 countries worldwide.
The Challenge
Before adopting TransPerfect Automate, CSL Behring's eTMF document quality review process was entirely manual, with a human involved at every step. A document owner would upload a file to the eTMF and route it through a workflow. The company's internal TMF QC review team would then check the document for ALCOA compliance and other quality attributes, while manually extracting content and entering it as metadata in line with CSL Behring's TMF reference model and indexing structure.
That level of manual effort introduced two related risks: a higher chance of human error, and slower turnaround times. If a reviewer identified an issue on a submitted document, it had to be sent back to the document owner, adding delay to an already queue-based process. CSL Behring needed a faster, more consistent approach to document review that could surface problems in real time rather than after they had already entered the review queue.
The Solution
CSL Behring chose TransPerfect Automate over other AI-enabled options it evaluated because it integrates directly into the company's existing eTMF repository rather than operating as a standalone service. For the team, that was the deciding factor. Layering in automation without disrupting the current technical setup meant avoiding the added change management that would come with introducing a standalone tool or moving data in and out of a system outside the eTMF.
With Automate built into the eTMF, CSL Behring can extract metadata from uploaded documents and flag potential issues in real time instead of routing every document through a manual review queue. The platform is also designed to support cross-checking and completeness measurement across the TMF. This can help reduce reliance on manual reviews while strengthening oversight and enabling a more risk-based approach to quality.
CSL Behring is working with both its internal technical and validation/QA teams, as well as the TransPerfect team, to plan the rollout. Rather than testing in a sandbox with dummy records, the plan is to pilot Automate on a live study within its production eTMF, allowing the technology to learn from real data from the outset.
The Impact
As CSL Behring prepares to pilot TransPerfect Automate, the team anticipates it will change, not eliminate, the role of its TMF QC reviewers. Rather than manually pre-approving every document, staff expect to shift toward overseeing technology-enabled QC and using the resulting insights to identify trends and inform broader mitigation strategies.
Over time, CSL Behring expects this shift to reduce the time and resources required for manual QC while enabling a more scalable approach to high document volumes across studies and vendors. The team also expects greater consistency and quality across the TMF, regardless of who uploads or reviews a given document. Ultimately, CSL Behring sees Automate as a way to help keep its TMF consistently inspection-ready.