Resource Library | Trial Master File and Inspection Readiness

Download The Agenda | Trial Master File and Inspection Readiness

Trial Master File and Inspection Readiness Forum is the easiest platform to bring your challenges and opportunities to the forefront of the industry and work in collaboration with your industry peers to find solutions to these challenges!In 2020 we'll be covering topics such as:

Industry Resources

Top Tips on Ensuring Interoperability and Successfully Migrating Systems

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...

Industry Report: Managing Communication Between Sponsors and CROs

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...

Exclusive Interview: How to Ensure TMF Inspection Readiness in 2019

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...

Avoiding Critical Findings in your TMF

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.

INFOGRAPHIC: 2019 TMF Industry Trends

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 ...

Revolutionising TMF Interoperability: The TMF Exchange Mechanism Standard

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...

Webinar Summary: Achieving TMF Excellence Through Sponsor and CRO Partnerships

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...

Top Challenges with Late Stage Trial Master Files

The transition from a paper to an electronic Trial Master File (TMF) system is a significant task. In many cases, some pharma and biotech firms (sponsors) may find that they are in the late stages of digitising their TMF system resulting in some documents being left as hard copies. Ahead...

Being Inspection Ready: Top Tips And Warnings

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’...

Conference Content

Exploring Strategy in Demonstrating TMF Completeness: Past Presentation

At the 2019 TMF Forum we heard from Christopher Betts, Clinical Operations Manager, UK & Ireland Country Head, DOCS as he discussed key strategies for demonstrating TMF completeness as well as a clear guide path to ensuring and measuring a successful TMF. As we begin preparations for the 2020 forum we...

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TMF & GCP Inspection Readiness Event Guide

With leading experts from across both big and small pharma sharing their insights, the TMF & GCP Inspection Readiness Forum, is a unique event that brings together professionals to network and discuss key solutions to overcome challenges! In 2020 we'll be covering topics such as: Preparing for inspections Maintaining effective...