3 min read
The promise of circulating tumor DNA (ctDNA) extends far beyond simply detecting cancer; it also holds potential for personalized treatment. As Dr. Gabriela Rosu, Veristat’s Vice President, Global Medical Affairs, recently explained, "If we know that...
1 min read
Learn how Veristat’s biostatistics and strategic consulting teams were able to work with a biotechnology sponsor to prioritize oncology indications through efficient trial design. The results of our collaborative efforts? Early identification of...
5 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...
2 min read
It was wonderful to connect with so many of our peers at RAPS Convergence 2025 in Pittsburgh. As the largest annual gathering of regulatory professionals, the event brought together more than 2,000 experts across pharmaceuticals, biologics, devices, and...
1 min read
Learn how our patient-centric approach helps sponsors streamline development and reduce trial burden without compromising rigor. Our collaborative efforts led to improved enrollment timelines, enhanced patient engagement, and accelerated submission...
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...
1 min read
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...