Leading Change: Effectively Guiding The Organization Through A Study Start-up Technology Transformation

Automating study start-up enables faster site activation, better collaboration with study partners, and more informed decision-making. The adoption of purpose-built study start-up technology, however, requires organizational buy-in and alignment. This paper examines common barriers to change and offers best practices to overcome them.

Introduction

Traditional methods used to manage study start-up – spreadsheets, emails, and file repositories – are slow and error-prone, resulting in costly delays for study teams. Research shows that missed start-up timelines can cost sponsors up to $2 million per month.¹

The rise of precision medicine, global subject enrollment in response to COVID-19, and protocol complexities make it challenging to manage start-up processes manually in today’s clinical trial climate. That’s why sponsors and contract research organizations (CROs) are turning to technology specifically designed to manage the intricacies of study start-up, with adoption increasing in 2020.

Deploying a new study start-up system requires careful coordination across multiple functional groups to ensure a successful launch and user adoption. Despite good intentions, the effort may stall if effective change management tactics aren’t implemented. This white paper addresses common barriers to change and best practices for overcoming them. Insights from successful deployments at top 20 pharmaceutical companies support the recommended practices.