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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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News and Press Releases

Biologics Day

On 20. July 2018, Phenomenex and SCIEX will co-host a full day of seminars, providing solutions for Biologics. The series of mini-seminars presented by technical experts from both companies, will cover methods for characterisation and QC testing, troubleshooting and new trends in analysis for this industry.  
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In summary, Russia remains a very popular geography for local, regional, and global pharmaceutical companies to conduct clinical trials. Sponsors mention the following reasons for conducting studies in Russia: 1. Fast patient enrollment due to the centralized medical infrastructure. 2. Nearly 100% patient retention 3. GCP trained and certified Investigative Sites generating high quality data 4. Low cost: Average per patient cost is 60% to 70% below US and European prices due to the low cost of Investigators and the high concentration of patients in therapeutically aligned medical centers
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Industry Events

SCOPE Europe: Summit for Clinical Ops Executives

16-17 October 2018, Barcelona, Spain

Building on the success of its long-running US-based counterpart, Summit for Clinical Trials Operations Executives Europe (SCOPE Europe) is a two-day event serving clin ops execs, functional heads, category managers and those responsible for the planning and management of clinical trials in Europe and the Rest of the World.
More info >>

 

 

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