Pharmacovigilance teams are under pressure to stay up to date with a wide range of drug data from a wide range of heterogeneous and cross-disciplinary sources. When time is of the essence and accuracy is crucial, SciBite makes the difference.
Build a greater understanding of available data with better ways to search and analyze information that may reveal issues and trends quicker.
SciBite helps you meet the regulatory body expectations around being aware of the safety implications of your drugs and similar drugs already in the market.
Ensuring that your processes and drug safety is compliant can pull resources away from other parts of the business, SciBite helps you manage this more effectively.
SciBite provides a resource-effective solution to the challenges faced by pharmacovigilance teams, enabling efficient and comprehensive monitoring of direct and indirect safety signals derived from a wide range of heterogeneous and cross-disciplinary sources.
Regulatory bodies believe pharmaceutical companies have a responsibility to stay up-to-date and well aware of the safety implications of their own drugs and competitor drugs from the same drug class or with the same target.
If there are a large number of similar drugs this can create a seemingly impractical large amount of data for pharmacovigilance teams to keep up with using traditional methods. SciBite helps to maintain safety and compliance by streamlining the process of monitoring and reviewing large volumes of drug safety information.
Spot safety signalsThe World Health Organization (WHO) defines a safety signal as: “reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously”.
SciBite can help pharmaceutical companies scan a range of credible data sources for these relationships and enable them to rapidly assess their validity so they can notify the responsible regulatory bodies within a reasonable timeframe.
Look beyond clinical trialsPre-marketing clinical trials that are designed to ensure safety can only do so much. Often, they don’t involve a sufficiently large or diverse population and are not long enough to detect all potential safety issues.
SciBite enables pharmacovigilance teams to assess more data more quickly to help facilitate more comprehensive, systematic monitoring of results, reports and other relevant documents.
Read more about the challenges pharmacovigilance teams are facing and how SciBite can help you meet your regulatory responsibilities.
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