Case Study: Urovant Sciences achieves FDA approval with eClinical Solutions' integrated clinical submission support

Urovant Streamlines Study Trial Submissions for Success with Clinical Biometrics Services

Urovant Sciences, a company focused on urologic therapies, faced a significant challenge in preparing a New Drug Application for its overactive bladder treatment. After acquiring the Vibegron assets, the company inherited numerous legacy studies that needed conversion to modern standards while managing multiple ongoing trials. To meet an ambitious eight-month submission timeline, they needed an expert partner and turned to eCliental Solutions for its biometrics services to streamline the process and ensure regulatory compliance.

eClinical Solutions provided a comprehensive solution, forming a collaborative partnership with Urovant to function as a single unit. Their team performed gap analyses on legacy data, implemented intelligent batching of deliverables, and conducted crucial submission dry runs to identify and resolve issues early. This proactive approach enabled the successful preparation of the entire integrated submission package. As a result, the NDA was submitted on time at the end of 2019 and received full FDA approval for Gemtesa in December 2020.

Urovant Sciences

Denise Shortino

Sr. Director, Biostats, Programming and Data Management