The new European Medicines Agency (EMA) guidance on Trial Master Files – “Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)” –was published on 6 December 2018. With the guidance in effect as of June 6, 2019, there is much you should know about its impact on TMF processes, technology, and best practices. Eldin Rammell explores how this could affect you.
We recently sat down with Marie-Christine Poisson-Carvajal, Head of TMF Operations to discuss how Pfizer ensures the quality and compliance of their TMF across various different trials and users through the use of their own in-house Quality Management System (QMS).
We have put together some of the most common critical findings related to TMF management in GCP inspections, these findings demonstrate the importance of robust information management, careful document presentation and highly organised data filing in maintaining an inspection ready TMF.
In both a paper and electronic TMF (trial master file) environment massive challenges delay the successful development, management and monitoring of an inspection ready TMF. In this exclusive Pharma interview Martin Thorley TMF Content and Integration Lead at Pfizer, shares his key considerations to make when implementing an eTMF system and the implementation steps that impact eTMF inspection readiness.