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...
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...
By Dr Stephanie-Jayne Jones How Pharmora can help Pharmora can provide support at any clinical stage in the product life-cycle and beyond. Effectively this means that from the moment a potential medicinal product is considered for a clinical trial we can work with the...
By Dr Stephanie-Jayne Jones Why do you need Pharmora? Medicines development background When a manufacturer discovers a new medicinal product there is a long process of development before it reaches patients in real world. Many products that seem to have amazing...
