In health care, clinical trials are conducted to allow safety
and efficacy data to be collected for new drugs or devices.
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
Clinical Trials can be classified their purpose as Prevention
trials, Screening trials, Diagnostic trials, Treatment trials,
Quality of Life trials.
three phases of clinical trials: the study of adverse effects,
effectiveness in small populations, and effectiveness in large
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.
A clinical trial
may involve testing a drug, a surgical or other procedure, or a
therapeutic or diagnostic device .
application issues and trends include : fficient electronic data
capture and storage
• The end-to-end clinical trials process is supported by a
fabric of non-collaborating applications, systems, and
• Corporate mergers and acquisitions magnify challenges
• Systems are supported by data managers in a labor-intensive
• FDA and similar regulatory agencies require validation of
computer systems to ensure the accuracy, reliability,
and consistent performance of applications and automated
• Use of electronic records and electronic signatures must
strictly comply with FDA 21CFR Part 11
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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