Case Studies Archive - Alacrita

Providing pharmacovigilance due diligence of a Phase lll oncology program

Written by John Simpson | Feb 8, 2017 8:58:43 AM

Challenge

A major pharmaceutical company asked us for support in the medical safety and pharmacovigilance due diligence and assessment of a Phase III in-licensing opportunity. The drug in question had met its primary endpoint in a pancreatic cancer Phase III clinical trial and our client was seeking ex-US rights to the program.

Solution

Working to tight timelines, our consultants worked with our client’s internal due diligence team, providing an external perspective and supplementing their internal expertise.

We identified some issues and gave recommendations to mitigate those risks. As a result, our client went ahead with the deal, which included a $100m upfront payment.