Top Tips.
Watch this space for the latest Top Tips from Pharmora.
Pharmora RMP Masterclass (2): RMP Development Process -TOP TIPS
In this blog our CMO, Dr Stephanie Jones, provides detailed guidance on how to save time and effort and produce high quality risk management plans. Read on to find out more!
IDMC Tips to Help You Prepare
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 al, 2015) in that area of research, and they are independent of the Sponsor conducting the trial.
Top Tips for CSR Safety Narratives
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 can be the busiest period when the team needs to focus on generating key messages for the completed study report (CSR) and potentially a marketing authorisation application.
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