Advarra Experts Featured in Almac Spotlight on IRT Podcast
Advarra Consulting’s Kathy Kelly and Ellen Liedel-Sargent were featured on The Almac Group’s Spotlight on IRT podcast.
In this episode, Liedel-Sargent and Kelly discuss the best practices for maintaining a trial master file (TMF) with host, Matt Lowrie. “At the end of the study, there should be only one TMF,” they explain. “If documents for the TMF are held with different vendors until the end of the study, there should be a very clear list maintained by the sponsor as to where the documents are maintained and who is responsible.”
Inspectors are looking at the TMF for completeness, meaning all documentation must be in place and organized appropriately.
The Almac Group is an established contract development and manufacturing organization providing an extensive range of integrated services across the drug development lifecycle to pharmaceutical and biotech sectors globally.