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SCOPE US 2025
SCOPE US 202516th Annual SCOPE Summit for Clinical Ops Executives
Veristat is excited to announce our participation in...
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Discussion with Erin Mathias, Sr. Director, Global Biostatistics
Biostatistics is at the core of every clinical trial. Data-driven decisions and the ability to make modifications throughout a trial have become must-haves rather than nice-to-haves due in large part to the growth of innovative trial designs and novel statistical analysis approaches such as adaptive trials, that allow for pre-planned interim adjustments to optimize trial outcomes. Biostatisticians, in collaboration with other key clinical and regulatory experts, have been a driving force in applying statistical innovations to clinical trials.
Erin Mathias, Sr. Director of Global Biostatistics at Veristat, shares her thoughts on the important role biostatisticians play in clinical trials.
Hands-on involvement in all aspects of clinical research
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Biostatisticians conduct all of the foundational statistical measures, including accurately defining endpoints, establishing the correct sample size, conducting timely data analysis, and ensuring correct randomization within a clinical trial. Without these proper measures, costly and time-consuming challenges can present themselves. For example, the ability to understand gaps or inconsistencies in data as the data is being collected – rather than racing to resolve questions during an analysis phase– is a useful best practice we routinely employ at Veristat. Our biostatisticians work alongside our data managers to get to the bottom of inconsistencies in a timely fashion.
Listen as Erin describes her approach to resolving a sponsor’s data inconsistency challenges, which supported a successful FDA submission: Understanding the Role and Importance of Biostatisticians in Clinical Trials
A highly experienced team powers partnerships and results
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The reality is that successfully conducting a clinical trial is highly dependent on the expertise of the project team. While Veristat’s medical affairs, regulatory, and clinical operations teams are experts in their roles, our expert biostatisticians understand the complexities of the data associated with specific therapeutic areas and the respective statistical methodology needed to analyze the data.
Veristat’s biostatisticians work closely with the entire project team, beginning with the study protocol and the statistical analysis plan, which outlines how the data will be analyzed and displayed in tables and figures. Together, we work to ensure that the correct data is captured and is always ready for analysis.
Listen as Erin describes the academic and professional backgrounds of Veristat’s biostatisticians and the value they hold for clients, especially small biotech companies: Biostatisticians Are Critical Experts in Clinical Research
Enriching lives while expediting new treatments
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It’s understood that randomized, controlled clinical trials (RCTs) are the FDA-preferred approach for registrational studies in new drug and biologics development. However, there are circumstances, particularly in oncology, where a single-arm trial can expedite the development of new treatments for oncology indications, reduce time to product approval and patient access, and demonstrate the clinical benefit of novel products on fewer patients. Single-arm studies are where only one experimental group is established, without the inclusion of a parallel control group. Biostatisticians work alongside our strategic consulting team members to advise on how best to develop a single-arm study design for registration. Single-arm trials can help bring novel therapies to patients quickly. It’s just one example of the way in which biostatistics can have a direct and positive impact on transforming a patient’s life.
Hear Erin share her reason for joining Veristat, and how it has enriched her professional journey: Patient Impact Is Why I'm at Veristat
Interested in understanding more about Veristat’s biostatistics capabilities? Click the link to learn more: https://www.veristat.com/services/biometrics/biostatistics
Want to speak with one of our Biostatisticians or any of our clinical or regulatory experts?
