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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.

  • 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.

  • Clinical Trials can be classified their purpose as Prevention trials, Screening trials, Diagnostic trials, Treatment trials, Quality of Life trials.

  • States undergo three phases of clinical trials: the study of adverse effects, effectiveness in small populations, and effectiveness in large populations, respectively.

  • 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 .

  • 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

  • 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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