25-28 September 2018 | UK

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Trial Master Files Sample Attendee List

Download a sample of the Trial Master Files attendee list.

Articles

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 matter and discussed the key issues being overlooked by most organisations

Infographics

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 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.

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. 

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 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 This draft guidance for TMF will replace what is currently in volume 10.

Interviews

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.

IQ Content

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.

PDF

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.

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.

Podcasts

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.

 


PDF

Trial Master File Inspection Readiness: CRO and Sponsor Perspectives

Ahead of the 2017 Trial Master File and Inspection Readiness summit, 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.