REDWOOD SHORES, Calif., Oct. 23, 2019 -- Oracle Health Sciences, a leader in eClinical technology and Phlexglobal, pioneers in the provision of Trial Master File (TMF) technology and services for the global life sciences industry, have announced enhanced integrations to accelerate the speed and accuracy of regulatory compliance and inspection readiness in clinical trials.
A TMF is a requirement that all sponsors and contract research organizations (CROs) must meet to assure that the rights, safety and well-being of trial subjects are protected, that their trials are being conducted in accordance with Good Clinical Practice (GCP) principles, and that the clinical trial data is credible to ensure audit readiness.
When my Trial Master File (TMF) career began, the TMF Reference Model did not exist. Every customer had a different way of organising the contents of their TMF, and it was rarely interpreted
Building the Right TMF Team for Inspection Readiness, Scalability and Growth As clinical trials become more complex, many Sponsors and CROs find themselves asking the same question: Do we need more
Why portfolio-level TMF oversight is becoming a necessity, not a luxury. The Problem With Thinking Study-by-Study Clinical trials do not happen in isolation. Sponsors and CROs are running multiple
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