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Clinical Trials

2 min read

Measuring What Can't Be Seen: How PTSD Clinical Trials Prove a Drug Works

When an oncology drug is tested, the signal is often brutally clear. A tumor either shrinks on a scan or it does not. A patient either lives or does not. In psychiatric drug development, the endpoints are almost never so crisp. In PTSD trials in...

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2 min read

The Psychedelic Setback: What MDMA Rejection Taught Drug Developers

In August 2024, the FDA declined to approve MDMA-assisted therapy for post-traumatic stress disorder. The decision followed a June advisory committee meeting in which panelists voted nine to two that the data had not shown MDMA was effective, and ten to...

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2 min read

Tackling the Complexities of Advanced Therapies for Neurology

Developing advanced therapies for neurology is often described as a “perfect storm of complexity.” These studies face scientific, operational, and ethical challenges that require careful planning from the earliest stages.

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2 min read

The Compound Effect of Specialized Knowledge

In life, specialized knowledge is required when guesswork is not an option.

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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...
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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...

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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,...

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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,...

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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,...

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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...

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