According to a recent survey, managing mid-study changes and their associated delays topped the list of challenges faced while conducting a clinical trial.
But there are ways to minimize the impact of mid-study changes.
“There are five components to any successful system change,” says David Goldston, President of Veracity Logic. “And thinking through them will help make the process more effective.”
Here’s the list:
1) Begin with a clear statement of the required change. This isn’t as easy as it sounds — spend the time up front to confirm with all stakeholders that the wording of the change is clear and correct. Misinterpretations can cost more in time and money than the change itself.
2) Remember that there’s often more than one way to implement a change. Cultivate partners whose project management and technical teams pride themselves on offering creative solutions to study problems A capacity for good dialogue between all members of the study team can reap great rewards. Implementation approaches often affect the time and effort (and cost!) of any given change; a clear understanding of the overall goal is a must.
3) Confirm that the lines of authorization in the study are clearly established and adhered to by all team members. Obtain written confirmation from the person(s) designated at study startup as authorized to order a change.
4) Check to make sure that a suite of quality controls is in place for proper implementation of the change and to capture and address any unexpected consequences that might result.
5) Ensure that technical audit trails and your document repository together constitute a clear information trail pre- and post-change.
Veracity Logic’s approach to change management has evolved over more than fifteen years of deploying global IRT systems. Our system is designed to expedite clinical trials – it’s modular and quick to configure, so we can meet tight deployment timelines.
Our experienced team is known for rolling up their sleeves and diving in to help clients meet their goals — and we respond quickly to changes. In fact, most changes to a project system can be completed in a matter of days.
Click here for a look at the components of a successful change management process from an IRT perspective.
To learn more about how Veracity Logic can support your next clinical trial, contact us to schedule a conversation or demo.