BH Life Sciences™ Case Study
Placing a Team of Onsite and Remote Pharmacovigilance Experts to Meet Urgent Timelines
Challenge
A small, oncology-based pharmaceutical company was preparing their first non-disclosure agreement (NDA) submission of their flagship product and recognized they needed a pharmacovigilance (PV) team to assist them. Although they had a small, established PV department, they lacked the bandwidth to complete the necessary elements within their aggressive deadlines and sought additional industry expertise from Beacon Hill Life Sciences.
Solution
We placed a team of four PV medical directors and four PV scientists. We also provided industry expertise and assisted our client with completing various PV materials, including integrated safety summaries, safety update reports, and risk management plans.
Achievements
We delivered a combination of onsite and remote resources to meet our clients’ aggressive deadlines and provided additional industry expertise to help them during this critical time.
