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Inspection Readiness

• Is your TMF ready for your next regulatory inspection?
• Can your team effectively support inspection-related activities?

Phlexglobal’s experience with TMF and eTMF requirements from a Regulatory Authority perspective is unmatched.

Our team of experienced document experts and consultants will help you prepare your TMF ahead of inspection through a selection of services at the Sponsor site, Contract Research Organization site (CRO), Investigator site or our offices.

Phlexglobal can help clients prepare their TMF through a variety of services:

  • TMF QC
  • TMF consolidation and re-mapping as appropriate
  • Supporting client teams to understand Phlexglobal processes (Phlexglobal teams at client sites)
  • Store TMF documents as required
  • Host inspection if required
  • Client site support – organization, interview scribing

What our customers say about us…

“Phlexglobal is a leader in the industry, offering expertise and excellent service…  Even the MHRA has asked Phlexglobal for advice on TMFs.” – Director of Records Management, top 30 global pharma

“Phlexglobal’s strengths are its expertise, its knowledge of legislation, knowing what the inspector wants, and how clinical teams interact. They are embedded industry experts.” – Senior Director in Clinical Operations, top 20 global pharma