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Pharmacovigilance is one of the most essential functions in the drug development process as it is vital for the continued safety evaluation of a product from the first time it is administered to a person through the post-marketing setting. A Pharmacovigilance program must be set up to detect, assess, understand and prevent adverse effects or other possible drug-related problems, and these activities require extensive documentation and monitoring. The global safety database is the primary tool to support Pharmacovigilance activities as it allows us to review safety cases across an entire investigational program rather than study-by-study. It is the Pharmacovigilance provider’s responsibility to ensure that the database is updated and maintained by inputting individual case safety reports (ICSRs) in a consistent, standardized, and timely manner.
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Medidata NEXT is hosted each year by PROMETRIKA’s technology partner Medidata to help sponsors stay informed on products and solutions for managing clinical trial data. I had the privilege of attending this year’s event in New York City as a PROMETRIKA representative. This was my first-ever industry conference, and Medidata NEXT set the bar high. The venue was in Times Square, and, upon entering the hotel, we were greeted with warm hospitality and a HUGE Medidata NEXT banner. The first event was the introductory keynote, which started with an impactful story of a diabetic mom and her daughter. This introduction served to remind attendees why we do what we do - help people living with medical challenges. The session continued for 2 hours and described the future direction of the Medidata platform.
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Clinical trials are rapidly evolving and becoming more complex as they continue to adopt novel technologies and approaches. Factors such as the number of sites and countries involved, study phase, indication, design, procedures, and the number of data sources and data points collected contribute to this complexity, imposing a strain on study execution. Furthermore, in recent years, the biopharmaceutical industry has witnessed changes in business practices and an increase in merger and acquisition activity.