Unblinded Medical Review (UMR): How does it work in Pharmora?

Unblinded Medical Review (UMR): How does it work in Pharmora?

By Josh 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 treatment has been assigned. Therefore, maintaining...
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...
CSR Safety Narratives – Part 1 of 2 (Saving your time and money)

CSR Safety Narratives – Part 1 of 2 (Saving your time and money)

Regulatory Guidance: Within a year of completing a clinical trial the Sponsor needs to provide a completed study report (CSR) to the regulatory agencies who approved the trial. According to ICH E3 guidelines “Structure and Content of CSR” there should be brief...