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Learn how our neuroscience team partner with sponsors across multiple therapeutic areas to accelerate trial success in complex neurological and psychiatric conditions. Our collaborative efforts have supported successful marketing applications,...
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In oncology drug development, randomized controlled trials (RCTs) are the gold standard for generating data to secure regulatory approval. The recent FDA Project Frontrunner (to read more about Veristat’s thoughts on Project Frontrunner, click here)...
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Learn how our regulatory affairs team was able to work with a sponsor to build a complete, FDA-compliant IND from scratch. Our collaborative efforts led to successful IND submission and initiation of clinical trials with confidence, preventing potential...
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Over the past two decades, the FDA has steadily increased the number of guidance documents it publishes each year. The agency issued about 101 guidance documents annually from 2005–2010, rising to 173 per year between 2011–2019, and more than 190 in FY...
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Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...
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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...