But according to Quintiles, not many of them do. In the U.S., doctors can voluntarily submit safety monitoring data to the Food and Drug Administration ( FDA) through a program known as MedWatch. Where does all that patient data go? Quintiles is banking on sponsors seeing the raw information as a valuable post-approval data windfall, and the CRO believes it can sell the data to clients as a unique service offering. iGuard can also poll the patients online for the occurrence of adverse events or for other useful information. The system uses a series of alert levels, such as ‘Low Risk,’ ‘Guarded,’ or ‘High Risk’ so patients know when to seek more information or ask a doctor more questions. If there is an issue with a consumer drug, such as a change in its prescription label, a side effect warning, or other warnings from the manufacturer or a medical journal, the system sends patients a form to take to their doctors.Īnd the site offers patients a simpler way to determine a drug’s general risk. Using secure methods through iGuard, patients anonymously provide demographic, disease treatment and medical history information to the site, along with contact information. The free service is called iGuard, a drug risk monitoring and personalized safety alert online site, and it’s a significant step toward patient-directed research. In an unusual move for a contract research organization (CRO), Research Triangle Park, N.C.-based Quintiles has created a new service specifically for consumers of prescription drugs.
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