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When our sponsor acquired an investigational asset from an international company, they faced a critical regulatory challenge: Could clinical data from foreign trials not conducted under a U.S. IND be included in their New Drug Application? The foreign...
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In a recent Trailblazers interview, Cindy Henderson, Chief Strategy Officer at Veristat, shared her inspiring career journey from the mailroom to the executive team. Her story is packed with insights for anyone working in clinical research—from clinical...
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In today’s regulatory climate, reports of staffing shortages and slowed review timelines at the FDA have sparked anxiety across the biopharma industry — especially for sponsors preparing for key submissions like INDs or NDAs. At Veristat, however, our...
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The FDA’s Oncology Center of Excellence (OCE) is shifting the paradigm in cancer treatment development with Project FrontRunner— an initiative designed to encourage drug sponsors to develop, test, and seek approval of new cancer drugs for advanced or...
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Complex therapeutic development requires deep integration across clinical, regulatory, statistical, and operational functions. Whether optimizing dose, navigating regulatory pathways, or accelerating timelines, early and sustained collaboration is...
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Electronic Common Technical Document (eCTD) submissions have transformed sponsor companies' interactions with global health authorities. Over the past two decades, eCTDs have evolved from a basic electronic substitute for paper to a robust, standardized...
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Medical writing plays an essential role in clinical development and regulatory approval. As scientific advancements grow more complex, well-structured documentation ensures the success of clinical trials, facilitates regulatory review, and accelerates...
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In today’s increasingly complex clinical research environment, sponsors must strike a careful balance between scientific rigor, regulatory readiness, and patient engagement. The goal is not simply to move faster—but to do so with greater efficiency,...
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Many sponsors underestimate how much support the Food and Drug Administration (FDA) can offer during early drug development, often believing they need more data than is truly required before engaging. But once your proof-of-concept data, clinical...
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Clinical Impact, Technology Innovation, and Emerging Advances in Cell and Vaccine-Based Oncology