1 min read
Developing treatments for neurological, psychiatric, or CNS disorders means navigating complex trial designs, subjective endpoints, and global variability, all under tight timelines. These complexities must be translated into submissions that regulators...
1 min read
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,...
2 min read
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...
4 min read
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...
1 min read
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,...
4 min read
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...
3 min read
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...
4 min read
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...