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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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Veristat developed a thorough regulatory submission strategy and novel efficacy endpoint for the treatment of an ultra-rare and aggressive hematologic malignancy that led to FDA and EMA approval following a single-arm...
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Clinical trials involving gene therapies for the treatment of Central Nervous System (CNS) indications are some of the more complex in the field of gene and cell therapy (G&CT) development. During the lockdown, the Food and Drug Administration (FDA)...
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As we are well-rooted in the response phase of the COVID-19 pandemic, we have seen a flurry of sponsors looking through their pipelines to find either approved or...
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The Food and Drug Administration (FDA) has started encouraging the use of adaptive designs for clinical studies. In essence, adaptive designs allow prospectively planned modifications to a clinical trial based on interim data, provided scientific...