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Learn how our biostatistics and strategic consulting teams collaborated with our biotechnology sponsor to advance dose escalation strategies through Bayesian modeling in a Phase 1/2 study for a novel oncology compound. Our efforts led to real-time,...
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In oncology drug development, every day counts. Patients are waiting, trials are complex, and the stakes are high. Getting from clinical development to regulatory approval requires more than simply assembling documents—it demands speed, accuracy, and...
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Learn how our strategic and regulatory team was able to work with a biopharmaceutical sponsor to advance oncology innovation through adaptive trial design. Our collaborative efforts led to successful execution of a multi-regional Phase 3 study with...
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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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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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Clinical Impact, Technology Innovation, and Emerging Advances in Cell and Vaccine-Based Oncology
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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 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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Discussion with Erin Mathias, Sr. Director, Global Biostatistics