Executive Summary
Pintels Drug Safety Intelligence reports provide insights into safety of biologics and therapeutics drug products. Pintels Drug safety intelligence analytics include:
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Data about drug safety from FDA and Multiple data sources
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Access to post-approval data
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Metadata management
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Regular updates of drug safety data
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Detect drug safety signals
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Drill-down capabilities to information related to case reports and more.
Key Benefits
Key benefits of Pintels Drug Safety Intelligence solution include:
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Provisions data mining capabilities and functionalities for signal tracking, signal management
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Know how the drug is performing in the market and improve drug safety monitoring
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Help identify key factors, leading to a more efficient system
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Enable early warning systems that can detect emerging trends
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Understand low frequency reactions
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Identify High Risk Groups
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Detect long term effects
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Enhance Post-market Regulation and Enforcement
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Gain deep insights, analytics reports from post-market regulation and enforcement data on your drugs and that of your competitors
Pintels Adverse Event Reporting Intelligence provides information on adverse event and medication error reports. The data is based on cases reported to FDA and supports post-marketing safety surveillance for drug and therapeutic biologic products. Medical Dictionary for Regulatory Activities (MedDRA) codes compliment the Adverse events and medication errors reported to FDA.
FAERS data includes the reports submitted to FDA by healthcare professionals - physicians, pharmacists, nurses and others) and consumers - patients, family members, lawyers and others. Adverse Event Reporting Intelligence reports are based on ten years of AERS data.
Key Benefits
Product Recall is a action taken by a firm to remove a product from the market. Recalls are made by manufacturer's own initiative or by FDA, as statutory authority.
All the recalls classified as Class I Class II and Class III as well as unclassified recalls can be found in FDA Enforcement Reports. The product areas considered for reporting include - Drugs, Biologics, Medical Devices, Food, Cosemetics and Veterinary products.
Other key reports include:
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Recalls by manufacturer's own initiative or by FDA
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Classification of Recalls into Class I, Class II and Class III
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FDA Enforcement Reports - The product types for reporting include - Drugs, Biologics, Medical Devices, Food, Cosmetics and Veterinary products.