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News
Pharmora’s Sparkling Prize Draw
At our most recent conference, Pharmora once again held our Prize Draw for a bottle of fizz! And the winner was …
Urology Awareness Month 2024
This September is Urology Awareness Month, an event which highlights the wide range of conditions and the incorrect assumptions that people can have of these urological conditions. Read on to find out more about the event…
Big Butterfly Count Blog
This year, to improve our mental health here at Pharmora, we took part in the Big Butterfly Count. This is an initiative which benefits not only people’s stress levels, but also our understanding of biodiversity – read on to find out more…
Top Tips
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.
Blog Posts
The importance of reporting adverse events
Have you ever experienced an adverse event after taking a medication? Did you tell a healthcare professional about it? Would you know how to report it? Read on to find out why it is important to report!
What is the summary of product characteristics and how does it help me?
The theme for #medsafetyweek2024 is “The importance of using medicines correctly to prevent side effects”. In order to do this we need some information on correct use. Where do we find this? Read on to find out!
Breast Cancer Blog (2) – Recent Advances in Breast Cancer
Following our recent blogs highlighting the necessity to raise awareness of breast cancer, Pharmora would like to take this opportunity dive in the recent advances in breast cancer detection and therapies, to understand how the pharmaceutical industry is joining the fight against breast cancer.
Case Studies
Unblinded Medical Review (UMR): How does it work in Pharmora?
In a follow up to the blog outlining what unblinded medical review (UMR) means and why it might be needed, this case study from one of the UMR team explains how Pharmora can support with UMR of clinical trial data.
Case Studies – Unexpected Signal Evaluations
Pharmora helped to meet a tight deadline for submitting an application for marketing approval by reviewing multiple signals to support the safety profile.
Case Studies – How Safety Saved a Study
Pharmora safety monitors conducted a signal evaluation that saved a clinical trial from disaster. Read on to find out how!
Master Class
Unblinded Medical Review (UMR): How does it work in Pharmora?
In a follow up to the blog outlining what unblinded medical review (UMR) means and why it might be needed, this case study from one of the UMR team explains how Pharmora can support with UMR of clinical trial data.
Unblinded Medical Review (UMR): what is it and when is it needed?
In this blog we explain what UMR means and why the Sponsors of clinical trials for investigational medicinal products might need it.
Pharmora RMP Masterclass (3) Updates to EMA guidance on RMMs
On 11th September there was an EMA webinar to launch the updates to GVP Module XVI on Risk Minimisation Measures and its Addendum II. Read on for a summary of the key updates…
Thoughts.
Watch this space for the latest News, Top Tips, Blogs and Master Classes from Pharmora.
See some of our other thoughts …..
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