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Med City News Innovation is not just a luxury but a necessity in the realm of clinical trials, particularly as we strive to accelerate drug development. Yet, the slow pace of innovation within the U.S. clinical trials system has impeded progress, leaving many stakeholders frustrated. U.S. Food and Drug Administration (FDA) resource limitations cause the […]

International Biopharma Data integrity is critical in Biopharma manufacturing yet is often difficult to achieve due to complex regulatory requirements and legacy data management systems, among the many factors. Furthermore, issues such as data accuracy, completeness and security impact product quality, regulatory compliance and ultimately patient safety. Addressing all these challenges demands a multifaceted approach […]

Applied Clinical Trials Decentralized clinical trials (DCTs) are shapeshifting. Originally piloted 15 years ago and more recently catalyzed by the COVID-19 pandemic, DCTs took center stage in 2020 and 2021—mostly out of necessity, but with great promise for their potential to dramatically improve patient access, enrollment, trial speed, data quality, and population representation. Now, in […]

25 September 2024 from 4:00PM to 5:30PM (CEST) Webinar Overview It has been demonstrated that using standards from the start of clinical research studies (i.e. protocol and CRF development) can save significant time and resources and results in higher quality research. Unfortunately, it is not always clear how to select the appropriate standards for the […]