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Strategic Consulting

1 min read

Achieve Regulatory Excellence and Accelerate Your Clinical Trials with Veristat

Learn how Veristat’s multidisciplinary team helped sponsors navigate the complexities of global regulatory submissions, achieving early and successful outcomes.

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4 min read

Webinar Q&A: How to Advance New Cancer Therapies in Alignment with FDA Project FrontRunner

In partnership with Clinical Leader, Veristat consulting, regulatory, and clinical experts gave a live webinar outlining how to better advance new cancer therapies in alignment with FDA’s Project FrontRunner. The webinar covered the following:

  • What is...
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1 min read

Harness the FDA's Project FrontRunner to Advance Your New Oncology Therapies

Are you interested in learning about the latest FDA initiative to accelerate the development of new cancer treatments? Veristat's informative webinar "Advancing Development of New Oncology Therapies, aligning with FDA's Project FrontRunner" is an...

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1 min read

How Veristat Helped a Global Pharma Company Navigate Complex Medical Writing Challenges

Learn how Veristat's expert medical writing team supported a global specialty pharmaceutical company with 130+ projects for rare disease treatments. Our longstanding thirteen-year relationship, built on trust and quality, continues to thrive as we help...

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2 min read

Navigating the IND Submission Labyrinth: A Veristat Success Story

At Veristat, we pride ourselves on transforming challenges into triumphs, particularly in the complex pharmaceutical and biotech development world. Our recent collaboration with a small-sized biotech company targeting cancers of the reproductive system...

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2 min read

FDA CDER’s Accelerating Rare disease Cures (ARC) Program

In 2022, the FDA’s Center for Drug Evaluation and Research (CDER) launched the Accelerating Rare disease Cures (ARC) Program to help bridge the gap between the urgent needs of patients and the complexities of rare disease drug development.

ARC’s mission...

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2 min read

Navigating Regulatory Challenges in Biologics: A Case Study in Overcoming Clinical Holds

In the intricate world of pharmaceuticals and biotechnology, every step of drug development is meticulously scrutinized by regulatory bodies. For small to medium-sized companies in the field, the journey can be fraught with challenges, especially in...

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2 min read

FDA Guidance Series on Patient-Focused Drug Development (PFDD) to Enhance Product Development and Regulatory Decision Making

As the industry continues to adopt a patient-centric approach, the use of real-world data is becoming increasingly essential in informing drug development and regulatory decision-making. To develop patient-focused strategies, researchers must gain a...

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4 min read

Executing Patient-Focused Drug Development (PFDD)

Veristat’s Science Advisory Board met on 14 March 2023 to discuss Executing Patient-Focused Drug Development (PFDD), with a focus on the application in rare diseases.

Patient health and wellness extend beyond biology and symptoms of disease, encompassing...

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2 min read

Unleashing Flexibility in a Rare Disease Gene Therapy Clinical Trial

In the world of biotechnology, where groundbreaking discoveries have the potential to change lives, adaptability and flexibility are paramount. Clinical operations can be a complex web of challenges, especially when dealing with rare diseases and gene...

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