Title: Electronic Clinical Trails
1Electronic Clinical Trials
2- Electronic clinical trials have come into vogue
in the clinical trials management system. - Simply put, an electronic clinical trial is an
automated system that tracks the entire
documentation history and trail of a clinical
study.
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4Features of electronic clinical trials
- Maintaining and managing system planning is the
basic function of electronic clinical trials - They help the healthcare or biotech organization
to perform and report their functions - In addition, electronic clinical trials also
contain contact information about the
participants in the clinical trial, and help the
company track important milestones and deadlines.
5electronic clinical trials
6The rationale for electronic clinical trials
- As the nature and complexity of clinical trials
have gone up in recent times sponsors (those
carrying out the research) have to work with more
number of clinical sites. Some of these are
spread over many countries and across varied
service providers who are many times located
equally far and wide.
7Advantages of electronic clinical trials
- The electronic nature of these eTMFs offers an
easier and more secure way of sharing all
documents relating to the clinical study, and
carries some benefits or advantages over paper
documentation - Clinical trials organizations need not have the
fear of loss or destruction of eTMFs - eTMFs are easily accessible in any site across
the globe in real time, unlike paper documents
that have to be transported to a particular site,
which could sometimes be located in another
continent.
8Challenges associated with electronic clinical
trials
As with any technology, while eTMFs offer
manifold advantages, they also bring in their
wake some issues and challenges. The main
challenge relates to security. The remedy to this
challenge is to put checks and controls at every
stage, which is time consuming and complex.
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