The development of Vibegron—a treatment of overactive bladder (OAB) condition in adults—began in 2017. Urovant Sciences acquired the Vibegron assets midway through its development process including numerous legacy data sets and an ongoing Phase III study. To achieve the ambitious regulatory submission timeline, the development team needed to partner with an experienced clinical data and statistical programming provider. Working with eClinical Solutions on the regulatory submissions and using the elluminate Clinical Data Cloud® as a centralized data repository, Urovant was able to achieve their submission timelines stretch goals that resulted in an approval for Gemtesa.
Challenge
Urovant needed to to prepare 17 legacy studies for submission and align them with ongoing studies, which required them to be converted to SDS, the creation of the TS trial summary domain, the SDTM annotated CRF, and a defined PDF. Since the TS domain requires deep understanding of the parameters of the study, creating these sets was challenging. Urovant was also working with multiple vendors on the studies and needed a final statistical analytics plan that aligned across these studies.
Solution
To meet these goals and be prepared for submission, Urovant needed a team with a proven track record of submission experience, and the ability to deliver quality results on time. The project required expert statistical and programming support, knowledge of CDISC standards, and the ability to be flexible in the face of challenges. Urovant turned to eClinical Solutions, taking advantage of their expert clinical programming team and lead statisticians.
As soon as data became standardized and available from the legacy studies, the eClinical team performed an inventory and gap analysis of the data and documentation that existed. This allowed for Urovant and eClinical to identify issues early on. With individual studies being run by other vendors, they performed submission package dry runs as data was received which allowed them to notice issues up front and fix them quickly and gave the joint team extra time to review data and the medical writing team more time for additional requests. With these processes in place, they were able to meet their timelines.
Result
The ISS package that eClinical and Urovant collaborated on included:
- Submission-ready integrated SDTM and ADaM-compliant data
- TLF outputs
- Statistical analysis plan
- BIMO packages
- eTMF documentation
- Expedited responses to regulatory inquiries
Along with a well-documented and well-defined plan, eClinical’s experienced biostatistics team created an efficient and successful submissions process to gain approval for Urovant Gemtesa.
Related Products + Services
Urovant Sciences met an ambitious 8-month submission deadline by utilizing the centralized data repository of the elluminate Clinical Data Cloud®. Expert statistical and programming support from eClinical’s Clinical Biometrics Services team ensured successful implementation of a well-documented plan, setting Urovant on the path to submission success.
Data Central
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Clinical Analytics
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Data Conversion and Standardization
Tech-enabled approach to shorten submission timelines and improved ability to support real-time creation of “submission ready” datasets.
Biostatistics
Experienced biostatisticians and SAS programmers provide strategic statistical input and programming to optimize clinical development and ensure regulatory compliance.
Streamlining Study Submissions for Success: An Integrated Summary of Safety Case Study
