Amersham, UK; Malvern, PA. — June 20, 2019 — Phlexglobal today announced an important industry advisory around the new European Medicines Agency (EMA) guidance on Trial Master Files. The guidance took effect on June 6, 2019, and promises to have far-reaching impacts on an organization’s TMF processes, technology, and best practices – as well as related departments and systems.
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
How Senior TMF Study Owners bridge strategy, mentoring and operational delivery. What does it really mean to have an expert in your corner when it comes to your Trial Master File? For organisations
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