Resource Library | Trial Master File and Inspection Readiness
Download The Draft Agenda | Trial Master File and Inspection Readiness
Whilst we put together the agenda for the 2019 TMF Forum - please view THE DRAFT AGENDA to get an OVERVIEW for the topics and interactive opportunities TO BE presented over the 4 days.
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 ...
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 inspec ...
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 ...
Trial Master File Inspection Readiness: CRO and Sponsor Perspectives
Pharma IQ gathered the perspectives of both the CRO and the sponsor in regards to the burning topic of inspection readiness when it comes to Trial Master Files.
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’ mistakes. ...
Additional Content Download
What Lies Ahead for Clinical Data Management?
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...
Implementing a Robust eTMF System - What to Consider
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.
The State of 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...
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.
Implementing a cost effective and interoperable e-TMF system
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.
Clinical Data Standardisation and Management: Where Do We Stand?
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.
Electronic Data Capture for Clinical Trials
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.
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...