TMF document processing

Our 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.

Are you having these issues?

• You have boxes filled with documents and don't know what's in them
• You acquired a company that had their studies all in "paper," but your policy is to have everything electronic
• An inspection is coming up and you want to digitize a paper study to make your TMF easier to inspect
• You want to free up some office space or save money on long-term storage for your paper documents
• You want to make your documents safer and more reliable

Digitize with us:

• We understand the needs of eTMF regulations around scanning. We give you a true replica of the paper original through the certified copy process
• We can do the classification, remapping, adding fields and codes to upload into an eTMF system
• We have experience from working on hundreds of these projects
• We have fit-for-purpose software that assists us on large projects to make sure scans are done correctly, audited and in the right place and in the software of your choosing
• We can provide add-on services like quality review and completeness checking on the paper on the way in

Example project

1. eTMF preparation/implementation: Build data folders/data structure
2. Record management: Document shipment into our records center
3. Certified scanning: Records to be digitized and uploaded into PhlexTMF
4. Study is in client's eTMF: Ability to search, view, and report on content

Cencora is an industry leader when it comes to 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.

A key component of our document processing services is our unmatched experience in the remapping and indexing of TMF documents. Cencora has the expertise to help with: 

• Consolidating multiple sources, structures, and file formats to a single TMF utilizing the TMF Reference Model
• Converting paper documents to a compliant eTMF
• Adding additional filing structures
• Indexing metadata for greater search granularity

Regardless of your records retention needs, we provide 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.