Kickstart Study Start-Up Performance: Insights From Allergan And Johnson & Johnson

By Ashley Davidson, Director Vault Study Startup, Veeva Systems, Inc.

Study start-up is a critical component of the end-to-end trial process, yet it continues to be a challenging area for clinical operations teams. Research shows the average time from site identification to activation is 7-8 months, and it takes 4-6 weeks longer today to execute study start-up than it did 10 years ago.¹ As companies become more global and grow through mergers and acquisitions, the number of clinical trials and systems increase, as do country, ethics, and regulatory requirements. With the rise of personalized medicine, protocols are also increasing in complexity. Excel trackers are ill-equipped to manage such intricacies, resulting in process and data silos that impede collaboration and add to study timelines.

How do two global top 20 pharma companies manage these complexities and improve start-up performance? Lorena Gomez, global director of study start-up at Allergan, and Sandy Freeman, GCO U.S. director MAO supported studies at Johnson & Johnson, share their insights on opportunities to accelerate study start-up and how their organizations leverage Vault Study Startup to maximize efficiency and effectiveness.