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Download The Agenda | Trial Master File and Inspection Readiness

Download The Agenda | Trial Master File and Inspection Readiness

Trial Master File and Inspection Readiness 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 2019 we'll be covering topics such as:

  • Preparing for inspections
  • Maintaining effective sponsor and CRO oversight
  • Improving TMF interoperability
  • Transitioning to and between eTMF systems
  • Securing senior management support for TMF activities

Submit your email to the right to view the 2019 Agenda and speaker faculty >> 

“I am so glad I did not miss this one! Highly relevant content, very helpful. Overall, a high standard of people ready to interact and discuss.” – GW Pharmaceuticals
Companies to already confirm their attendance include: 



Exclusive Interview: How to Ensure TMF Inspection Readiness in 2019

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 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.

INFOGRAPHIC: 2019 TMF Industry Trends

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 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.

Top Challenges with Late Stage Trial Master Files

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 of the 2017 Trial Master File conference we examine the top challenges that are attached to operating trials with a late stage TMF.
Interoperability: The Top 5 Benefits and Burdens of Utilising the CRO eTMF

Interoperability: The Top 5 Benefits and Burdens of Utilising the CRO eTMF

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.