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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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4 min read

Regulatory Guidance Monthly Review - August 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...

READ MORE

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...

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