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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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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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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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Historically, oncology drug development followed a straightforward principle: identify the highest dose patients could tolerate without unacceptable side effects, then use that dose in subsequent trials and clinical practice. This maximum tolerated dose...
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The regulatory landscape for cell and gene therapies (CGTs) is shifting fast. From increased scrutiny on Chemistry, Manufacturing, and Controls (CMC) to operational challenges at the U.S. Food and Drug Administration (FDA), sponsors must be prepared to...
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The decision to partner with a Clinical Research Organization (CRO) is never taken lightly—especially in oncology. With high complexity, accelerated timelines, and evolving regulatory expectations, the stakes in oncology drug development are uniquely...
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The development of innovative oncology therapies has evolved dramatically, moving beyond traditional chemotherapies to include immunotherapies, targeted agents, radiotherapies, and cell and gene therapies. As these new modalities emerge, the limitations...
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Learn how Veristat’s multidisciplinary team helped sponsors navigate the complexities of global regulatory submissions, achieving early and successful outcomes.