When new drugs are approved, the marketing authorization holders often have to commit themselves to perform additional post-authorization studies. These studies have a different set up. Most countries have adjusted the regulations for studies where the drug is commercially available; although there is no "one fits all" concept.
Challenging Study Timeline Goals Achieved in Global Post-Authorization Safety Study (PASS)
PRA Health Sciences Late Phase Services is participating in a global real world safety study program, mandated by various regulatory bodies, to…
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THE INSIGHT SERIES: Why do prescribers participate? - Part III
While Phase II-III studies include small datasets, comprising several hundred to several thousand patients, they provide the data necessary for drug…