We are intended to provide an update of the worldwide safety experience and efficacy with the detailed periodic safety update reports of medicinal products to Competent Authorities at set intervals of time. PSURs are counted as essential pharmacovigilance documents and they are subject to extreme scrutiny at the time of inspection by the regulatory authorities.
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Data Management supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). The ultimate goal of CRDM is to assure that data support conclusions drawn from research. Achieving this goal protects public health and confidence in marketed therapeutics.
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