For inspection-readiness, the critical attributes of TMF health are completeness, timeliness, and quality. To achieve and maintain ongoing TMF health and inspection readiness – the “TMF Health Zone” – requires experienced people trained on effective processes using the right technology.
Failing to look at the big picture and how these are functioning together leads to major gaps in TMF Health, putting your ability to take your compound to market at risk.
Phlexglobal's balanced approach to TMF Health helps you
The regulatory requirements around TMF are increasingly a focus of inspections by FDA, EMA, MHRA and other regulatory authorities. Trial sponsors have ultimate responsibility for the health or their trials' TMFs. Phlexglobal offers additional advantages including:
Phlexglobal is unique among eTMF providers.
We leverage dedicated and authoritative TMF technologies and expert services to bring order, stability, and control to your Trial Master File – helping you achieve the highest standards for completeness, timeliness, and quality.