RMP Masterclass (2): RMP Development Process By Dr Stephanie-Jayne Jones Click here if you have missed the 1st Pharmora RMP Masterclass Risk management plans (RMPs) have evolved since the legislation was implemented in the EU in 2012 mandating an EU-RMP for every new...
Tips for preparing for an IDMC Written by Anu Matthew What is an IDMC? An Independent Data Monitoring Committee (IDMC) is a group of experts contracted to review data during a clinical trial. The members are individuals with ‘extensive clinical experience’ (Sartor et...
Top Tips for CSR Safety Narratives Written by Dr Steph Jones CSRs (Completed Study Reports) Whether you are working with an external service provider or creating them in-house the safety narratives always cause a great deal of work right at the end of the study. This...
