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These CDISC standards must be successfully implemented at different stages in the drugdevelopment process. How do CDISC standards fit into the drugdevelopment process? That means your team has greater control, transparency and communication. If you want to find out more, you can have your own customized demo.
One of the most tragic was the thalidomide disaster, in which pregnant women prescribed the drug to treat morning sickness suffered severe birth defects. This made drugdevelopers realize that flaws in the manufacturing process could go unnoticed. By the late 1970s, the concept of process validation was introduced.
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