Managing Change In Clinical Trials: The Data Management Playbook

The need to manage change in clinical trials is unavoidable. With so many moving parts, preparing for the unexpected and improving efficiencies is a necessary practice. In addition to moving parts, a multitude of stakeholders, each with different and often conflicting priorities, make managing change even more challenging. Stakeholders such as CROs, clinical data managers, clinical research coordinators, clinical operations, IRBs, IT, security, privacy and compliance have different approaches to managing clinical trials and aren’t always prepared for change.

Change requires people to do things in new ways to either meet unexpected roadblocks or to improve upon the way existing tasks are carried out. Learning to do things in a new way takes time and effort. When teams make this kind of process investment, people can’t focus 100% on their core functions. This in turn can cause bottlenecks and delays which drive up costs. The stakes increase further if patient outcomes are impacted.

But it doesn’t need to be this hard. Planning for change related to the single most critical and thorny element of clinical trials − the data to support the therapy submission – can save substantial time, money, and resources in the short and long run.