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International Clinical Trials

Revolutionary Potential

For clinical research, the shift away from paper has been a
long and gradual process. Decades have now passed since
electronic data capture (EDC) was first implemented in a trial,
yet, to this day, some researchers remain beholden to paper
case report forms (CRFs) and databases. In fact, even those
who have switched are not fully electronic, as data is only
entered into the system after it is captured on a paper CRF at
the site level. In other words, while EDC has taken great strides
in modernising the operations of clinical data managers,
workflows at the site level are largely the same – as far as
data capture is concerned – as before the emergence of
eClinical technology.

This is one of the central reasons why the advent of eSource
technology – which allows data to be entered directly into
an electronic system and shared remotely with no paper
involved – represents a watershed moment for research.
eSource is largely seen as an improvement to timelines and
data integrity and, therefore, a boon for sponsors and CROs.
However, it is from these sites that these improvements
emanate.

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Mike Novotny is founder and CEO at Medrio. He previously served as President of the EDC software company Ninaza before founding Medrio in 2005. Mike has 20 years of experience in research and software and holds a BA from Stanford University, US, and an MBA from Columbia University, US.

Nick O’Brien
is Marketing Copywriter at Medrio, where he writes the company blog as well as press releases and other copy. He has extensive experience writing for blogs and other media and holds a BA in English, with an emphasis on creative writing, from Kenyon College, US.
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Mike Novotny
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Nick O'Brien
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White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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Industry Events

12th Annual Paediatric Clinical Trials

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