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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

Regulatory Guidance Monthly Review - October 2023

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...

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1 min read

Positioning a Sponsor’s First Trial for Success: A Comprehensive Planning Approach for Cancer Antibody

Clinical trials require meticulous planning and strategic guidance for success. In this case study, Veristat's expertise was instrumental in transforming a clinical-stage biotech company's maiden Phase I trial for an immuno-oncology antibody.

Initially...

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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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4 min read

Regulatory Guidance Monthly Review - September 2023

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...

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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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3 min read

Natural History Study Best Practices for Engaging Regulatory Authorities

When seeking guidance from the FDA, EMA, or other regulatory agencies regarding the inclusion of a Natural History study in your clinical development program, it is crucial to initiate early and frequent discussions with the regulatory authority to...

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2 min read

Your Guide to Mastering CMC Regulatory Success in Biotherapeutics: A Must-Watch Webinar

Biotherapeutic development is challenging due to evolving industry standards and increasing regulatory scrutiny. A roadmap for success is essential. Watch Veristat's on-demand webinar on Regulatory CMC Excellence in Biotherapeutics, including key...

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1 min read

Unlock the Secrets of Effective SD File Preparation for FDA Submissions

In today's world where digital transformation is reshaping industries, even the pharmaceutical sector is not immune to regulatory compliance. The FDA approval process has become significantly streamlined with the introduction of electronic record...

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