Case Studies – Unexpected Signal Evaluations

Case Studies – Unexpected Signal Evaluations

The Background A Phase II trial with a new oncology product had an unexpectedly fantastic result, years in advance of the Phase III studies reading out. The project leaders wanted to use this Phase II trial as a pivotal study to submit an application for marketing...
Case Studies – How Safety Saved a Study

Case Studies – How Safety Saved a Study

The Problem An oncology clinical trial hit disaster when a patient experienced a suspected, unexpected, serious adverse reaction (SUSAR) and the Investigator reacted very strongly. He insisted on unblinding the subject, and having previously led one of the top...
Case Studies – Providing an Entire Safety Department

Case Studies – Providing an Entire Safety Department

The Background A manufacturer of biosimilar medicines partnered with a large global pharmaceutical company to conduct the pivotal clinical trial with the aim of applying for global marketing licences for a new oncology biosimilar product. The Problem Both companies in...
9th Global Pharmacovigilance & RWE Forum

9th Global Pharmacovigilance & RWE Forum

On the 30th and 31st of May 2024, the 9th Global Pharmacovigilance & RWE Forum was held in the Hilton London Kensington. This conference was part of the Pharmacovigilance World Tour by Why Summits conference organisers. Pharmora Principal Scientist John O’Brien...
Regulating AI in Pharmacovigilance

Regulating AI in Pharmacovigilance

Everyone is talking about AI: What is it? Will it take our jobs? Will it save the world or will it ruin everything? So when I was lucky enough to be invited to a panel discussion called “Regulating AI in Pharmacovigilance” I jumped at the chance. This is a topic of...