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International Clinical Trials

Shredding Paper

The informed consent process represents the keystone in a
clinical trial, the space where science meets the patient. As
healthcare began to globalise in the 1990s and 2000s, process
and presentation flexibility became crucial. With technology
spreading around the globe, the defects and difficulties in the
use of text-only documents, reported internationally for 30
years, became even more apparent. Patients worldwide decreed
that text-only paper consent forms were confusing, hard to
and sometimes in different languages. Patients frequently
breezed through paper forms without truly understanding
the material and were surprised by aspects of the trial once it
started. This led to frustration and subjects often dropped out
of the consent process or the trial itself.

With the globalisation of clinical research, creating a flexible
system that works across international boundaries, yet respects
the differences of countries and regions, is imperative.

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Eric Delente, President at DrugDev Patient Solutions, has more than 20 years of experience leading technical and creative teams in the design and implementation of numerous award-winning online science, healthcare and clinical research web applications. Most recently, he led SecureConsent, the industryís definitive eConsent solution.
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Eric Delente
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