Blog | Veristat

4 min read

The Science of Simultaneous Submissions: Managing Multiple Regulatory Pathways

Bringing innovative therapies to patients worldwide no longer necessitates sequential engagement with regulatory agencies. The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, and Japan’s Pharmaceuticals and...

2 min read

De-Risking the Neurology IND: Lessons from Early FDA Engagement

Developing therapies for neurological diseases represents one of the most challenging frontiers in modern biotechnology. With subjective clinical assessments, high variability in outcomes, and substantial investment requirements, neurology programs face...

4 min read

The ctDNA Clinical Trial Advantage: Why CRO Work Puts You on the Cutting Edge

In the rapidly evolving field of circulating tumor DNA research, being on the front lines of clinical trials offers unparalleled insights into the future of cancer care. As Dr. Gabriela Rosu, Veristat’s Vice President, Global Medical Affairs, observes,...

4 min read

Early Detection vs. Overdiagnosis: The ctDNA Screening Paradox

The promise of circulating tumor DNA for early cancer detection comes with a complex paradox: the very sensitivity that makes ctDNA valuable for catching cancer early also raises concerns about overdiagnosis and overtreatment. As Dr. Gabriela Rosu,...

1 min read

Accelerate Neurology/Psychiatry Trial Success with Expert Guidance

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,...

3 min read

Beyond Detection: How ctDNA Could Optimize Treatment Selection

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

Accelerating Patient-Centric Trials: A Sponsor Checklist for Science-Based Planning

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...

3 min read

FSP/Resourcing: Meeting the Moment with Expert Resources

Clinical trial leaders in small and medium-sized biotech companies regularly find themselves at the intersection of growing requirements, shrinking timelines, and talent shortages. With organizational restructuring and staffing reductions continuing,...

1 min read

Exploring Future Trends on European Regulations: A Webinar by Veristat and TOPRA

Veristat, in partnership with TOPRA, recently hosted an insightful webinar titled "Future Trends on European Regulations on Medicines." This webinar provided valuable updates on the new Pharmaceutical Strategy for Europe and its impact on the regulatory...

1 min read

Unlocking Insights: The Impact of New Medical Device EU Regulation (MDR)

Veristat and TOPRA recently hosted an informative webinar on the topic of the impact of new EU regulations on the development of medical devices and drug combination products. The European Commission's adoption of Regulation (EU)