Additional Content Download
Collecting, storing and curating the vast quantities of scientific data in existence is not just important for regulatory submissions, but is also vital for ongoing pharma research and clinical trials. Carole L Palmer, a professor of library and information science at the University of Illinois, share her views on the matter and discussed the key issues being overlooked by most organisations
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. Thorley also reveals his key lessons learned after implementation.
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.
Process and Quality, Quintiles and Pharma IQ take a closer look at how a modern day global contract research organisation (CMO) is approaching eTMF and assess the top 5 benefits and burdens of utilising the CMO’s electronic trial master files.
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 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 This draft guidance for TMF will replace what is currently in volume 10.
Download a sample of the Trial Master Files attendee list.
In this podcast Andrew Miller, Director of Clinical Information Standards at Astrazeneca, discusses data management and the efforts to standardise the approaches to data management.
How do we ensure our clinical research increases in effectiveness and efficiency while decreasing costs? This podcast discusses the reasons, challenges, benefits and results likely to be seen from these integrated eClinical ecosystems.
At the TMF and Inspection Readiness Forum 2017, Sanofi presented a case study on 'Migration of an EDMS and eTMF Tool'.
At the TMF and Inspection Readiness Forum 2017, Danish Medicines Agency presented on Electonic Trial Master Files.
At the TMF and Inspection Readiness Forum 2017, AstraZeneca presented a session on 'Inspection Readiness during TMF Transformation'.
At the TMF and Inspection Readiness Forum 2017, Karyopharm Therapeutics presented a session on 'Trial Master File Through The R2 of ICH GCP'.