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After great work through some busy periods from all the Pharmora team, it felt time to get everybody out the office to unwind, and the arrival of Agatha Christie’s thrilling murder mystery ‘The Mousetrap’ at Buxton theatre couldn’t have been a better excuse to do so.
After opening ideas up to the team, it was suggested to a greatly positive response that Pharmora try out an afternoon of litter-picking the local area.
In June 2023 Pharmora launched its values – read about these here!
In June 2023 Pharmora moved offices due to continued growth – read about our exciting new location and facilities in Macclesfield here!
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.
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.
When medicines are first introduced to market, although there has been extensive research done in a clinical environment, it’s known that only the more common adverse events are likely to have presented themselves due to the small sample size.
Signal management is a key activity in pharmacovigilance, allowing the identification of new risks associated with a medicine. Manufacturers of medicines and regulatory agencies are constantly managing signals. But what is a signal and how are they managed?
Reporting adverse events is crucial in identifying potential safety issues and relevant risks in drug administration. An adverse event (AE) is any untoward occurrence that is experienced by a person following administration of a medicinal product or a medical intervention to that person. An adverse reaction is an AE that is suspected of being related to that product or intervention.
Patient safety is defined as the avoidance of unintended or unexpected harm to people during the provision of health care (NHS, 2022). The idea was first pioneered by Florence Nightingale, who used charts and other figures such as graphs to show relationships between hygiene and patient outcomes.
As part of Med Safety Week, the focus for this year is on promoting patient safety and a topic highlighted in this year’s theme is adverse drug reactions (ADRs), including raising awareness of potential ADRs and the importance of reporting these events.
In one role a client was in urgent need of a medical scientist to join the team and aid in an important date base lock. The data base lock was significant as it was the final analysis of data relating to their primary end point of overall survival, prior to moving onto their secondary endpoint of progression free survival.
Watch this space for the latest Pharmora Master Class series of blog posts!
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