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Veristat supported a Sponsor from SPA rejection to BLA submission, bringing strategic expertise to a small client team tackling their first clinical stage program for a novel ophthalmic therapy.
A pre-commercial biopharmaceutical company came to Veristat for consulting services following rejection by the FDA of their application for a special protocol assessment (SPA). This outreach to Veristat was a result of the sponsor representatives having had a prior successful working relationship with our Biometrics team while at another biopharma organization.
The sponsor’s SPA rejection was based primarily on the study protocol not having clearly
defined endpoints, nor the statistical analysis plan having a comprehensive method for handling missing data, particularly in relation to the efficacy of the study drug. 
From our initial consulting activities and FDA meeting attendance, we transformed the clinical trial design and the statistical foundation of the SPA, which helped drive the SPA to regulatory agreement. Our collaboration expanded to include Biostatistics and Statistical Programming for the first Phase III study, and Biostatistics, Statistical Programming, Data Management and Project Management for subsequent studies. Veristat supported the statistical analysis plan and statistical programming of the Integrated Summary of Safety (ISS).
Well-planned statistical strategy leads to SPA approval
Successful clinical studies demand well-founded statistical approaches. Collaborating with Veristat Biostatistics, Statistical Programming and Data Management experts early and regularly helped to ensure a strong SPA which reflects a strategic and clear clinical trial design, statistical analysis plan, and implementation of the study protocol. This ultimately laid a solid foundation for subsequent Phase III studies and successful BLA.
Access the full case study to learn how Veristat overcame the study challenges of missing data and lack of clearly defined endpoints quickly and effectively. Download the Case Study
Learn More:
Read more about how to manage operationally complex submissions — as well as tips for data analysis and medical writing in these complicated projects —in our White Paper on the topic: “Successful Preparation Strategies for NDA/MAA Marketing Applications.”
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