Clinical trial management system

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Clinical trial management system (klin-i-kal try-al man-ij-ment sis-tem) is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research. The system maintains and manages planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones.

Etymology

The term "Clinical trial management system" is derived from the combination of three words: "Clinical", "trial", and "management system". "Clinical" (from the Greek klinikos, meaning 'bed') refers to the observation and treatment of actual patients rather than theoretical or laboratory studies. "Trial" (from the Anglo-French trial, meaning 'a try, test') refers to a test of the quality or usefulness of something. "Management system" refers to the framework of policies, processes and procedures used by an organization to ensure that it can fulfill all the tasks required to achieve its objectives.

Related Terms

  • Clinical Trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
  • Clinical Research: A branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use.
  • Biotechnology: The use of living systems and organisms to develop or make products, or "any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use".
  • Pharmaceutical Industry: The industry which discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered (or self-administered) to patients, with the aim to cure them, vaccinate them, or alleviate the symptoms.

See Also

External links

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