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

Entering the Post-Paper Realism: The Principles of Cyber Ethics

The Shoulds and Shouldn’ts of Electronic Systems and Data in Clinical Trials Intro With the word should being mentioned 569 times and constituting ~7% of the content (only outweighed by data – 618

Overcoming TMF misfiles and metadata errors to reduce inspection risk

Trial master file misfiles are a common occurrence, with as many as one in every 10 documents being misfiled.   In some ways, misfiles are an even greater issue now with eTMF systems, where filing is

TMF Management in Clinical Trials Blog 3: Running the Trial in Your eTMF

Introduction Well, first and foremost, welcome!   Rob Jones has relinquished control and I’ve been given free rein to bring you the last blog in the series on TMF Management in Clinical Trials. Those