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
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 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.
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.
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.