C ASE STUDY SAE Report Expertise Ensures Complete and Adaptable Support for Biopharma Client THE CLIENT A United States–based biopharmaceutical company that develops therapies for serious medical conditions with limited treatment options or unmet medical needs PROJECT SCOPE The client turned to ProductLife Group in 2008 for support in managing its serious-adverse-event (SAE) reports. ProductLife Group also manages suspected-unexpected-serious-adverse- reaction (SUSAR) reporting and aggregate report submissions for the company. In 2012, with ProductLife Group’s help, the client received its first marketing approval based on safety data gathered from its studies. ProductLife Group commits a team of 16 pharmacovigilance team members to this client, which is a significant increase

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