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

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Posted: 05/18/2015

In the build up to Trial Master Files Europe 2015, Claire Mooney, TMF Lead - 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.

 

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As one of the most heavily regulated industries in the world, the success of clinical research relies heavily on accurate documentation and data management. Collating and maintaining well organised, accurate documentation that is easy to access and inspect is harder than it sounds. Moreover, inaccurate clinical data and critical findings have significant budgetary implications. This puts a lot of pressure on clinical operations teams and TMF owners!

Interoperability: The Top 5 Benefits and Burdens of Utilising the CRO eTMF
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By:
Posted: 05/18/2015

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