Computer application in pharmaceutical and clinical studies pdf
Computers in Clinical Development
The use of Computers in Clinical Development has been evolving rapidly. The clinical development branches can broadly be categorized into two. The Clinical operations team as the name signifies works towards conducting the trial in all aspects that relate to its medical feasibility while following the prevailing regulatory laws. Broadly their job includes CRF development, distribution, versioning, corrections, approvals, recruitment of sites, investigators and local labs. They have to maintain a close eye on the study with respect to its medical outcomes and act as a bridge between the data management team and the investigators.
Computers in preclinical development has become an integral part of pharmaceutical research and development. Pre-clinical development involves the testing of a prospective drug on animals to determine its safety and dose that can be used in humans. After this initial study on animals, an Investigation New Drug IND application needs to be filed with the regulatory authorities. An IND application may require as much as 50, pages of supporting documentation. The data for every single data point has to be collected, managed, analyzed, reported, audited and finally archived as per the prevailing regulatory laws.
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