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PHARMACEUTICAL RISK MANAGEMENT
Achieve Balance in the Real World
 Pharmaceutical risk management is the method by which regulatory agencies such as the FDA will balance expedited approval of beneficial new drugs against potential serious adverse events that may occur once products are distributed across a wide market. The Sentrx SafetyTrak® risk management solution provides life science companies with the tools needed to detect, evaluate, and mitigate pharmaceutical risk.
A pharmaceutical risk management plan can range from standard labeling to strict limitations on prescribing. According to the FDA, an estimated 25% of new drugs approved will require a pharmaceutical risk management program beyond the package insert. In addition, existing therapies such as antidepressants and acne medications are under intense scrutiny by regulatory authorities and consumer groups worldwide for suspected serious adverse drug reactions. Sentrx offers three categories of pharmaceutical risk management programs to meet the requirements for new product approval and obtain the real-world data needed to study these effects:
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