www.productlifegroup.com Page 1 of 2 C ASE STUDY US Biotech Gains Broad Pharmacovigilance Support ProductLife Group Ensures Data Quality Consistency and Clear Oversight THE CLIENT A US-based biotech company focused on drug development for orphan indications PROJECT SCOPE The client requested clinical pharmacovigilance support from ProductLife Group for an investigational medicinal product’s phase I/II trial to be conducted in Europe and the United States. The project is expected to run for a couple of years. ProductLife Group was asked to provide EudraVigilance support, safety database setup and maintenance, and full project setup, which would include preparation of a safety management plan, case processing (including all follow-ups), proactive global regulatory intelligence and main

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