BiotechSourced

Case Study: Vertex cuts EDC study build times in half with Veeva Clinical Data

Vertex Case StudySourced & dated by Case Study Desk

Key facts · TL;DR

Company

Vertex

Industry

Biotech

Challenge

EDC study builds historically took 13-14 weeks

Headline result

40% faster first study build and 50% less UAT effort with Veeva Vault CDMS

Key results

40%

faster first study build

8 weeks vs. 13-14 week historic norm

50%

reduction in EDC build times

early-phase study builds cut in half

50%

less UAT time and effort

risk-based, live UAT approach

The challenge

Vertex's clinical data management team wanted to accelerate electronic data capture (EDC) study builds, which historically took 13 to 14 weeks. User acceptance testing (UAT) was especially time-consuming, with each review round taking one to two weeks.

The solution

Vertex adopted Veeva Vault CDMS (Veeva Clinical Data) and worked with Veeva to standardize study builds and run live, interactive UAT sessions. The team also applied a risk-based approach to reduce the number of items checked during testing.

“Live UAT updates are a game-changer. We eliminate three to four weeks from our timeline.”
VG
Vikas Gulati
Executive Director of Clinical Data Management and Metrics, Vertex

The results, in context

Vertex built its first early-phase study in eight weeks, 40% faster than its 13-to-14-week norm, and completed the next in six weeks, cutting build times roughly in half. A risk-based, live UAT approach reduced the time and effort required for a recent UAT by 50%.

Products used

Veeva Veeva Vault CDMSVeeva Veeva Clinical Data (EDC)