Global Document Processing

Available when you need it, where you need it

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Ensure completeness, accuracy, and consistency from source to archive

Phlexglobal provides a unique balance of document processing expertise, scalable global resources, and advanced technologies to ensure your  documents are processed according to your time frame and SOPs—regardless of your eTMF provider.

 

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Scanning & Paper Processing

Scanning & Paper Processing 

Phlexglobal’s highly precise and efficient end-to-end digitization process for scanning, indexing, and remapping clinical research documentation incorporates thorough quality control and compliance checks at every step. Leveraging experienced trial document administrators and advanced technologies, our proven process offers you fast and accurate scanning, with full audit trail and traceability.

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Electronic Document Processing

Phlexglobal has established the industry benchmark for the efficient and accurate processing of electronic trial documentation. Regardless of your source and destination systems or TMF/file structures, we resolve inconsistent or missing metadata as well as corrupted, missing, or encrypted documents. Built-in quality control, expert remapping, and experienced indexing further help ensure the quality and completeness of your TMF.
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Expert Remapping & Indexing

A key component of Phlexglobal’s document processing services is our unmatched experience in the remapping and indexing of TMF documents. Whether consolidating multiple sources, structures, and file formats to a single TMF utilizing the TMF Reference Model, converting paper documents to a compliant eTMF, or adding additional filing structures and indexing metadata for greater search granularity, Phlexglobal has the expertise you need.

Storage & Archiving

Regardless of your records retention needs, Phlexglobal provides highly secure and reliable options compliant with the latest regulatory mandates. Obtain ready access to secure short-term records, and enjoy the certainty that long-term TMF archives can be retrieved according to applicable regional directives.  We can also help you ease the burden of document management and archiving for your investigator sites, allowing them to focus more time and effort on your study and GCP—while preserving data integrity.
TMF Archiving

Reduce Risk and Improve Inspection-readiness with Expert TMF Document Processing

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Download the infographic, “How to Improve TMF Document Processing Speed and Quality” to learn why companies worldwide are relying on Phlexglobal’s leadership in TMF best practices to:

  • Get an average 95% “right the first time” document processing accuracy, regardless of volume or system
  • Benefit from the latest techniques such as risk-based QC and advanced workflows to accelerate identification and remediation of inconsistent or missing documents and metadata
  • Improve inspection-readiness through expert quality review and completeness assessments
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Latest News

Smart Steps to Managing Your TMF Audit Trail

The term audit trail can be daunting for companies, but this is a regulatory requirement. Simply put, when it comes to the trial master file (TMF), if an action is not recorded in the audit trail,

Lowering the TMF temperature through quality reviews

We are thrilled to announce Season 2 of our exciting webinar program, Summer Shorts: TMF Excellence Edition! Avoid boring summer reruns and attend these fresh, informative sessions where our experts

Five-step Game Plan for a TMF Close-out

Close-out of a clinical trial raises many questions about responsibility and management of the trial master file (TMF). According to ICH E6 (R2), final close-out can only occur when the monitor – or