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An emerging biotech company recently took a preventative approach to mitigate risks, identify potential concerns before an FDA inspection, and submit their NDA. See how these proactive measures accurately addressed gaps within its application and led to a successful submission.
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Biopharmaceutical companies — particularly smaller or emerging organizations — often are unable to draw maximum value from contract research organizations. This occurs for any number of reasons, several of which are covered in this e-book.
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Unexpected shifts in budget and unanticipated change orders happen. Gain insight from several clinical operations experts into the significance of meticulous contract examination when choosing an outsourcing partner to better prepare for these instances.
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Compared to traditionally frequent on-site monitoring, risk-based monitoring offers a modern approach that promotes a more targeted and flexible strategy. Learn how RMB can enhance the efficiency and effectiveness of trials while maintaining data integrity and patient safety.
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No matter how brilliant a clinical trial process or a technology may be, it is useless without skilled, motivated individuals at the helm.
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Thursday, December 14, 2023 | 11:00 a.m. EST
Join industry experts as they discuss the strategic, conceptual, and operational implications of the shift toward risk-based monitoring in the ICH E6(R3) draft guidelines, and what sponsors and vendor partners should already be doing to thrive in the future of clinical trial management. Register.
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