By Russell John, Global Director of Grants Management and Operational Excellence, Clintrax
In a clinical trial, everything depends on contract execution and budget development; when they are not appropriately managed, progress across other study start up areas comes to a halt. Monitors cannot complete site initiation visits. Sites can’t be activated. Patients are unable to enroll. Valuable time is wasted, which costs dearly.
We’re not describing a worst-case scenario: This is the way it usually works—or more accurately, doesn’t work—today. Lack of strategic planning, lack of communication and lack of transparency create avoidable errors, unnecessary delays and higher costs.
Today, roughly 57 percent of the time spent on site activation involves contract and negotiations. Median site contract cycle times doubled from approximately 1.5 months in 2010-2011 to more than three months in 2014-2015, and the trend shows no sign of abating.
This is a tremendous source of frustration, one the industry has been grappling with for years. The way sponsors and CROs handle budgeting and contracting is inefficient and exhausts valuable time and resources. They too often fail to align the appropriate resources to complete the contract and budget work successfully.
They want to optimize the process, but they don’t know where to begin.