CRO Services Center (Phase IV)
Phase 4 trials, also known as a post-approval studies, post-marketing surveillance trials, or real-world evidence (RWE) studies, are generally conducted after a Phase 3 trial is complete and a drug has received regulatory approval.
In a Phase 4 trial, side effects are studied over time in users of the drug after it has become commercially available. These trials allow the drug to be studied in a real-world population, which can be much more diverse and inclusive than the patients who took part in a Phase 3 clinical trial. The tools and technologies required for a Phase 4 trial are similar to those used in a Phase 3 trial. The conduct of these trials can also be managed by a CRO.
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WCG is the world's leading strategic partner to sponsors, CROs, institutions, and sites providing agile, knowledge based services that proactively optimize clinical development programs.