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What Lies Ahead for Clinical Data Management?

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

Implementing a Robust eTMF System - What to Consider

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

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.

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.

Implementing a cost effective and interoperable e-TMF system

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. 

Trial Master Files Sample Attendee List

Trial Master Files Sample Attendee List

Download a sample of the Trial Master Files attendee list.

Clinical Data Standardisation and Management: Where Do We Stand?

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

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

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.
Past Presentation: Case Study - Migration of an EDMS and eTMF Tool - Sanofi

Past Presentation: Case Study - Migration of an EDMS and eTMF Tool - Sanofi

At the TMF and Inspection Readiness Forum 2017, Sanofi presented a case study on 'Migration of an EDMS and eTMF Tool'.

Past Presentation: Electonic Trial Master File, Philip Lange Moller, Danish Medicines Agency

Past Presentation: Electonic Trial Master File, Philip Lange Moller, Danish Medicines Agency

At the TMF and Inspection Readiness Forum 2017, Danish Medicines Agency presented on Electonic Trial Master Files.

Past Presentation: Inspection Readiness during TMF Transformation - AstraZeneca

Past Presentation: Inspection Readiness during TMF Transformation - AstraZeneca

At the TMF and Inspection Readiness Forum 2017, AstraZeneca presented a session on 'Inspection Readiness during TMF Transformation'.

Past Presentation: Trial Master File Through The R2 of ICH GCP - Karyopharm Therapeutics

Past Presentation: Trial Master File Through The R2 of ICH GCP - Karyopharm Therapeutics

At the TMF and Inspection Readiness Forum 2017, Karyopharm Therapeutics presented a session on 'Trial Master File Through The R2 of ICH GCP'.