BH Life Sciences® Case Study

Pharmacovigilance

Beacon Hill Life Sciences recently placed a PV team consisting of 4 PV Medical Directors and 4 PV Scientists to assist a small, oncology-based pharmaceutical company in preparing for their first NDA submission of their flagship product.

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Challenge

The company had a small, established PV department prior to engaging with Beacon Hill Life Sciences, but lacked the bandwidth for completing the Integrated Summaries of Safety, Benefit-Risk evaluations (specifically pertaining to cardiotoxicity), safety update reports, risk management plans, and other various PV materials.

Solution

Under management of the VP of Pharmacovigilance, Beacon Hill Life Sciences delivered a combination of on-site and remote resources to meet the aggressive deadlines and to bring additional industry expertise to their team during this critical time.