Ahead of the TMF and GCP Inspection Readiness Forum 2020 in September, we spoke to Brenda Brown, Director, TMF Operations Lead, Pfizer, to discuss TMF completeness and the benefits associated with using an electronic TMF.
Brenda also shares some of the difficulties associated when subcontracting out an eTMF and the success Pfizer has experienced from creating an in-house eTMF.
At this years event, Brenda will be taking part in a number of panel discussions entitled, 'Acquisitions, Collaborations and Divestitures (ACDs) and Their Implications on a TMF', and 'What is the Best Practice for Staying ‘On-Track?'.
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Did you know that eTMF exchange mechanism can help with system interoperability? It can centralise the exchange of data so that a CRO can leverage their system and a sponsor theirs.
Ahead of the TMF and Inspection Readiness Forum 2019, we spoke with Rebecca Halbur, Senior Manager, TMF Systems at Biogen about the biggest challenges with interoperability and migrating systems , and how to address those challenges using processes such as the eTMF exchange mechanism.
In our exclusive conversation, Rebecca reveals lessons learned, as well as Biogen’s strategy to ensure their TMF system is inspection ready.
It is critical that Sponsors and CROs manage their communication effectively in order to facilitate efficient TMF handling during, and after, the clinical trial. In light of this, we have gathered exclusive feedback from both Sponsors and CROs to understand which areas the industry feels are the most challenging when it comes to TMF management, their recommendations for how to improve problem areas, and predictions for how the increased use of eTMF platforms will affect data management.
We interviewed Head of TMF Operations at Pfizer, Marie-Christine Poisson-Carvajal and asked her how Pfizer ensures the quality and compliance of their TMF across different trials and users with an in-house Quality Management System (QMS). In our exclusive interview with her, she gives her top tips on how other companies can create robust TMF processes even if they don’t have an in-house Quality Management System. She also explains why it is critical to building a good team who can bridge communications between internal and external operational groups.
DOWNLOAD THE FULL INTERVIEW and benchmark your TMF approach.
We have put together an infographic detailing 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.
With regards to making your TMF inspection ready in 2019, we conducted an industry-wide survey to understand the key areas and TMF trends for the next 12 months. This infographic aims to answer these pain-points:
- What TMF challenges are being faced by the industry?
- What type of TMF solutions are companies interested to use to overcome those challenges?
- What areas will be their main focus, in order to optimise their TMF system?
Download this hot-off-the-press infographic and find out where the industry is headed!
This infographic was made ahead of the TMF Inspection Readiness Summit, taking place in Belgium (17 - 19 September 2019 )
Find out more about the event by downloading the agenda here.
Ahead of his participation in the Trial Master Files & Inspection Readiness Forum, we spoke exclusively to Paul Fenton, TMF Reference Model Steering Committee member and co-chair of the exchange mechanism standard, about the key benefits of creating a common standard for TMF document exchange. In this interview we discussed with him how the standardised exchange of TMF using the new specification will affect the relationship between sponsors, CROs and the vendors, and how the standard is likely to shape the future of eTMF system exchange.
We are delighted to bring you a summary of our webinar on ‘Achieving TMF excellence through Sponsor and CRO partnerships,’ providing practical advice from both perspectives on how to build a transparent, resourceful and mutually beneficial partnership.
Webinar Speakers: Scott McCulloch, Director of Clinical Quality at InClin Inc. and Vittoria Sparacio, Head of Clinical Documentation at GlaxoSmithKline Pharmaceutical Research and Development
By having visibility on how far away the reality of an airtight Trial Master File is, a pharma firm has an opportunity to alter the project’s trajectory if needed. This transparency can be obtained via a range of avenues which include: solid metrics, clear oversight, frequent exchanges with the CRO and accurate understanding of the required documents.
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.
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.
Download a sample of the Trial Master Files attendee list.
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'.
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.
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.
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.
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