Case Study

Aggregate Safety Reports: How Technology Supports Development

Aggregate Safety Reports: How Technology Supports Development

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SLIP SHEET Aggregate Safety Reports: How Technology Supports Development Types of Aggregate Safety Reports Supported by PRA’s Technology PRA’s technology supports Development Safety Update Reports (DSURs), Investigational New Drug (IND) Annual Reports, Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), and end of study safety reports. The technology supports generation of the report as well as the submission at regular specified intervals according to local regulatory requirements, in order to inform about findings from safety data analyses, the ongoing assessment of risk to clinical trial subjects and patients, the evolving safety profile of the investigational drug or approved product,

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