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Were you able to join Veristat’s live webinar- “Strategies for Solving the Challenges of an Extraordinary Natural History Study – Navigating the Patient Experience When Pivoting to a Virtual Model Mid-Study”?
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Each year, Veristat regulatory experts present timely, relevant topics to members of The Organization for Professionals in Regulatory Affairs (TOPRA), a UK-based organization committed to driving regulatory excellence across the healthcare regulatory...
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Clinical trial activity remains strong in the area of new vaccine development, as COVID-19 continues to impart tremendous health and societal impact on our world.
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What we know as work has experienced a major transformation. This shift and the changes it precipitated have affected how we now conduct and perform monitoring of clinical trials.
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Veristat has experience in preparing more than 120 marketing applications. Our exposure to in creating new drug applications (NDAs) and marketing authorization applications (MAAs) has taught us two main lessons:
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When database locks are delayed, or regulatory agencies request additional analyses for new drug applications (NDAs) or marketing authorization applications (MAAs), it seems there is no alternative but to take a hit to the timeline — or is there?
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No two New Drug Applications (NDAs) or Marketing Authorization Applications (MAAs) are the same. However, they all have common aspects that create the opportunity for streamlined operational tips.