Phlexglobal offers a wide range of quality focussed TMF services, supporting companies through the entire TMF lifecycle — from initial assessment, through to inspection support and paper/electronic archiving.
Phlexglobal follows an established expert process to ensure excellence and that the highest level of quality of the TMF is achieved, whether it is paper or electronic.
Inspection readiness is often a main driver for TMF quality – Phlexglobal’s TMF Experts are second to none with Inspection readiness support.
- TMF Quality Control – TMF QC is carried out by our team of trained and experienced individuals who check the TMF documentation at several key stages through the clinical trial process, often upon receipt of documents and pre-archive, at a Sponsor site, Contract Research Organization (CRO) site or Phlexglobal offices.
- Inspection Readiness – Phlexglobal’s TMF experts help sponsors prepare for inspections by Regulatory Authorities with TMF quality control procedures, TMF consolidation and remapping, TMF document storage and inspection hosting.
- Archive Review – Phlexglobal focuses on security, safety and confidentiality of archive content for any records management projects that include receiving, assessing and organizing large numbers of client boxes containing TMF and non-TMF documentation. Phlexglobal has designed its own tracking system, PhlexEtrack, which ensures that boxes are identifiable throughout the process, ensuring chain of custody.
- TMF Remapping – Phlexglobal has extensive experience in re-mapping of TMF documents. Our TMF teams support various remapping efforts including the creation of one consolidated TMF from Sponsor and CRO, re-mapping from one CRO/Sponsor TMF structure to another and we are experts in re-mapping to the TMF Reference Model.
- Short Term Records Storage – Phlexglobal maintains state-of the art dedicated records storage centres in both UK (Chesham) and USA (Philadelphia) for live TMF paper storage.
What our customers say about us...
Director, top 5 CRO
Director, Business Operations, top 15 global pharma