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In health care, clinical trials are conducted to allow safety
and efficacy data to be collected for new drugs or devices.
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Depending on the
type of product and the stage of its development, clinical
trials enroll healthy volunteers and/or patients into small
studies initially, followed by larger scale studies in patients
that often compare the new product with the currently prescribed
treatment.
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Clinical Trials can be classified their purpose as Prevention
trials, Screening trials, Diagnostic trials, Treatment trials,
Quality of Life trials.
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States undergo
three phases of clinical trials: the study of adverse effects,
effectiveness in small populations, and effectiveness in large
populations, respectively.
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A clinical trial
is a study involving humans to find out if a treatment or
diagnostic procedure, which is believed to benefit a patient,
actually does so.
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A clinical trial
may involve testing a drug, a surgical or other procedure, or a
therapeutic or diagnostic device .
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Clinical trials
application issues and trends include : fficient electronic data
capture and storage
management capabilities
• The end-to-end clinical trials process is supported by a
fabric of non-collaborating applications, systems, and
databases
• Corporate mergers and acquisitions magnify challenges
• Systems are supported by data managers in a labor-intensive
process
• FDA and similar regulatory agencies require validation of
computer systems to ensure the accuracy, reliability,
and consistent performance of applications and automated
processes
• Use of electronic records and electronic signatures must
strictly comply with FDA 21CFR Part 11
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Clinical trials
applications are driven in large part by the availability of FDA
certified applications and database management systems on a
specific target architecture.
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India Scenario,
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