Veeva Systems
184 Case Studies
A Veeva Systems Case Study
Bayer’s study-startup team, prompted by COVID‑19, had to rapidly shift from traditional on-site clinical trials to digital and decentralized approaches. The pandemic exposed shortcomings in change management, SOPs, system validation and vendor qualification, training, and the ability to track site activity across regions.
Guided by senior director Amy Kisken, the team used scenario-based change management, revised SOPs for virtual workflows, strengthened validation and vendor qualification, and invested in training while consolidating systems on a cloud platform. The combined approach reduced qualification and validation time, improved remote oversight and data capture, sped study start-up, and increased operational flexibility for ongoing digital trials.
Amy Kisken
Senior Director, Study Startup and Conduct Specialists