Unblinded Medical Review (UMR): How does it work in Pharmora? By Joshua Bryning During a sponsor-blinded study the majority of the study team are blinded and do not have access to much of the clinical trial information, but the patient and investigator know which...
Unblinded Medical Review (UMR): what is it and when is it needed? By Dr Stephanie-Jayne Jones Pharmora has many times been called upon to help with data review near the end of Phase III clinical trials, when the global study team find there is too much to do and their...
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...
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...
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...
CSR Safety Narratives - Part 2 of 2 (Saving your time and money) Challenges with creating CSR Narratives Narrative categories A narrative needs to be drafted for each participant in a clinical trial who experienced an event that fulfilled the criteria outlined in the...
