Case Study
Streamlining Study Trial Submissions for Success: An Integrated Summary of Safety (ISS) Case Study with Urovant Sciences
Project Background Clinical research and drug development relies on partnerships and collaboration more than ever before. 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, set forth by Urovant leadership, 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.
■ Founded in 2017 ■ Headquartered in Irvine, CA ■ Focused on developing and commercializing innovative therapies for a range of urologic conditions
Preparing for Submission The development of Vibegron—a treatment of overactive bladder (OAB) condition in adults—began in 2017. Urovant acquired these asset and data, then submitted their NDA in 2019, aiming to get FDA approval by 2020. The submission package deliverable was an ambitious, eightmonth timeline. For successful submission, there were a few hurdles that they needed to prepare for: ■ Conversion of 17 legacy studies that were inherited to be SDS compliant ■ Conversion of three legacy studies to the latest CDISC data standards ■ Three ongoing studies: One in Phase 1 and two in Phase 3 ■ ISS scope: Integration of six studies using a complex pooling system, and the submission of ISS and individual studies with over 600 outputs
Submission Data Challenges There were substantial challenges to preparing the 17 legacy studies for submission and aligning them with the ongoing studies that Urovant was performing. The legacy studies needed to be converted to SDS, along with relevant data and documentation. Conversion to SDS also required the creation of the TS trial summary domain, the SDTM annotated CRF, and a defined PDF. Since the TS domain requires deep
Products Utilized Biometrics Services
Success highlights 1. Submission-ready integrated SDTM and ADaM-compliant data 2. FDA approval in December 2020