1 min read
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
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
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
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
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
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...
2 min read
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
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
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...
4 min read
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...