A noteworthy proportion of emergency hospital admissions in the UK are due to an Adverse Drug Reaction. There is a well documented process for such events to be reported to the competent authority by clinicians, patients and consumers. This information is fed into huge databases and much of the time in pharmacovigilance within drug companies is spent on processing such data.
The important aspect, in terms of drug and patient safety, comes in the analysis of many unrelated and incompatible data sets to pick up whether there are new risks associated with a particular drug or combinations of drug, or whether risks have changed.
Our TEAM support pharmaceutical companies in all aspects of signal detection. From the detection of a spontaneous signal. Identifying whether there is a causal link between the medicine and the reaction to managing the process to recommending an action.
It is an incredibly complex, time-consuming but fascinating niche in particular post-marketing of drugs and one of the most rewarding.
Our QPPV TEAM can help you with:
- Signal detection
- Validation and Confirmation
All steps are accurately tracked and logged for the purposes of due diligence.
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