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Overview of Clinical Trial and Pharmacovigilance Process and Areas of Application of Computer System
Abstract
The overall process of getting a drug to the market is a long one and takes 10-15 years and costing close to a billion dollar. The success rate as the compound travels from the initial discovery phase to clinical and then through to the market is about 1 in 10,000. The two key phases which together contribute the most to the cost and timeline are clinical development and pharmacovigilance. These two phases together also account for the maximum number of failures. In this chapter, we will look in detail at these two phases with a focus on the business process and process areas which have application of computer systems. The chapter will focus on looking at the various phases of clinical development and their endpoints. Clinical development is the process of testing a drug for safety and efficacy in human subjects. Clinical trial is conducted in 3 phases with the 4th phase which is ongoing post approval which forms an important part of the pharmacovigilance process. These phases will be elaborated in detail.
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