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Creating a comprehensive and accurate database of efficacy and safety information

  • R. N. Smith
Chapter

Abstract

The investigational licence for a new medicine granted to a pharmaceutical company requires all clinical experience to be fully documented. The company has a legal responsibility to provide complete and accurate evidence of the new medicine’s efficacy and safety to the regulatory authority granting the licence. Impeccable records of the clinical and laboratory observations from clinical trials must be held by the company. The process of collecting and of checking the information requires regular visits to investigators. A major task begins once these records are received inside the pharmaceutical company.

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Reference

  1. [1]
    Anderson J R. Clinical data processing in the United States: report of a questionnaire in the pharmaceutical industry. Pharmaceutical Medicine 1987;2:239–44Google Scholar
  2. [2]
    Donovan H C. The organisation of clinical data processing in the United Kingdom. Pharmaceutical Medicine 1987;2:245–50Google Scholar
  3. [3]
    Smith R N. Does worldwide clinical research accelerate the development of new drugs? Drug Information Journal (in press)Google Scholar

Copyright information

© The International Federation of Associations of Pharmaceutical Physicians 1988

Authors and Affiliations

  • R. N. Smith

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