Pharma Vigilance

Pharmacovigilance, often referred to as "pharma vigilance," involves the activities related to the detection, assessment, understanding, and prevention of drug-related adverse effects. This is crucial for ensuring the safety and efficacy of pharmaceutical products. It encompasses monitoring of side effects of medications during clinical trials and after they have been approved for use in the population.

The Corsano Medical Certified Bracelet (CE-MDR, FDA Pending) is utilized in pharmacovigilance by providing a means to monitor patients' health and collect real-time data during clinical trials or after a drug has been approved and released to the market. Here are the use cases:

Real-Time Remote Monitoring of Vital Signs: Corsano CardioWatch 287-2 continuously collects physiological data such as heart rate, heart rate variability, arrhythmias (AFib), saturation, respiration, temperature, blood pressure, activity, and sleep patterns. This comprehensive data collection allows for close monitoring of patients' health status while they are participating in clinical trials or using pharmaceutical products.

Early Detection of Adverse Events: By monitoring vital signs in real-time, the Corsano Bracelet provides early detection of adverse events or changes in health parameters that may indicate a potential safety concern related to a medication. This allows for timely intervention and reporting of adverse events to healthcare providers or pharmaceutical companies.

Data Transmission and Analysis: Data collected by the Corsano Bracelet is transmitted wirelessly via a mobile application or gateway to the Corsano Certified Health cloud for analysis. This facilitates efficient data collection, storage, and analysis, enabling pharmaceutical companies to monitor large numbers of patients simultaneously and identify trends or patterns that may require further investigation.

Medication Adherence Monitoring: The Corsano Bracelet includes features to track medication adherence by reminding patients to take their medication and recording when doses are taken. Moreover, changes in parameters may indicate deviations from the prescribed medication regimen, allowing for timely intervention to address non-adherence issues.

Long-Term Safety Surveillance: Corsano CardioWatch can be used for long-term safety surveillance of pharmaceutical products by continuously monitoring patients' health parameters over extended periods. This allows for the detection of rare or long-term adverse events that may not be apparent during short-term clinical trials.