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...
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...
Case studies – Data Quality Management

Case studies – Data Quality Management

Medical Review of Clinical Trial Data: preparing for interim analysis The Problem A Phase III oncology blinded randomized controlled trial was heading towards an interim analysis when the study team realized they needed support to check the data for accuracy ahead of...