Case Study: Insmed achieves fast, successful EDC study builds with Veeva Systems' Vault CDMS

Fast and Successful EDC Study Builds with Veeva Vault CDMS

Insmed, a biopharmaceutical company, faced a late-stage shift in strategy when a Phase II feasibility study in a new indication became the program-leading first trial. That change required establishing data collection standards on short notice and managing numerous last-minute protocol and CRF design changes that threatened existing timelines.

Insmed partnered with Veeva Vault CDMS and a dedicated Veeva team to run an agile, in-person CRF design process with real-time updates, a shared sandbox, and a joint change log. The team built 30 eCRFs (22 directly from the protocol), completed rules and edit checks within a week, integrated with Suvoda IVRS, and finished UAT in seven days (32 issues found and resolved), enabling Insmed to meet its deadline and successfully go live.

Insmed

Janine Del Vecchio

Director of Data Management Insmed Incorporated