Blog | Veristat, The Science-First CRO

1 min read

Veristat Joined the Battle to Fight Rare Cancers for the Tenth Year Running with Cycle for Survival 2024

We did it again! A Successful Cycle for Survival Ride Raising Over $90K To Support Rare Cancer Research

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Pursuing Breakthrough Therapies for Rare Metabolic Diseases: Veristat's Role in a Landmark Clinical Study

At Veristat, we recently embarked on an ambitious journey alongside a biotech organization specializing in gene therapies for metabolic diseases. Our engagement entailed supporting their Phase I/II clinical study for a rare human genetic lysosomal...

3 min read

Regulatory Guidance Monthly Review - December 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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Elevating CNS Drug Development: Veristat’s Agile Approach in Medical Writing and Project Management

Precision and efficiency are key in the intricate world of CNS drug development. Veristat's recent collaboration with a clinical-stage biopharmaceutical company showcases an agile medical writing and project management approach, revolutionizing the...

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...

3 min read

Regulatory Guidance Monthly Review - November 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...

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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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...

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...

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...