Dirty data not only impacts the accurate assessment of individual case safety reports, but it can also lead to an inaccurate assessment of the effectiveness or risk of the product in question. It can create delays in the detection of safety signals and jeopardize the safety of our patients.
Additionally, an organization can incur significant costs and time expenditures associated with trying to clean up or convert bad data. Ultimately, this corrupt data can lead to the risk of unnecessary regulatory actions, such as requiring changes in product labeling, design, packaging or distribution. It could result in safety alerts being issued or even products being recalled, eventually leading to additional studies to demonstrate the product’s safety prior to it being allowed back on the market. Between the recall, alerts and additional testing, it could needlessly cost pharmaceutical companies millions of dollars.
Ashfield Pharmacovigilance is focused exclusively on pharmacovigilance. Our established expertise and robust processes allow us to help ensure you are minimizing the negative impact of dirty data within your organization.
Read the whitepaper on Minimizing dirty data in animal health.