From Mapping And Tracking Your Route to an eTMF to remaining inspection ready, this ebook explores the task of implementing a cost- effective and interoperable e-TMF system.
If you were handed with a notice for a clinical trial inspection plan right now, how would you react? - With a feeling of asserted confidence or a rush of slight concern? Wherever you think you would stand on this spectrum, use this interactive infographic to learn from your peers’ mistakes.
Pharma IQ invites the expertise of Andy Fisher Senior GCP Inspector MHRA on a list of common TMF failings. Alongside a number of other EU member states, Andy was recently involved in drafting guidance that the EMA is due to publish shortly. This draft guidance for TMF will replace what is currently in volume 10.
In this infographic we reveal the results of the Trial Master Files Europe 2015 survey conducted by Pharma IQ to gain a better understanding of how companies are planning to advance their TMF system and ensure inspector readiness in the next 12 months. Find out what are the biggest challenges surrounding the implementation of an electronic trial master file (eTMF) system and the most popular methods of exchange TMF documents with external parties, plus investment levels and priorities for the next year.