The end of a clinical study is usually quite hectic between trying to close a database and resolving all the outstanding study issues. We believe there is a strong correlation between the amount of planning time upfront and the time and effort required on the back end of a study.
Proper planning upfront can greatly reduce the stress of closing a study. For example, identifying questionable clinical data early in a site’s study activity can bring to light the need for clarification of study procedures or more site training. Ultimately, sites will experience fewer overall errors and more efficient and quick resolution of any data errors that are found. Likewise, risk-based remote clinical site monitoring can lead to earlier resolution of data errors, resulting in shorter time to database lock at the end of a study.
These are just a couple of examples of the types of upfront planning opportunities that can lead to reduced time and stress in closing a study. But try as you might, it is all but impossible for a clinical study to be conducted exactly as planned.
A good example of this is the recruitment rate, since most studies take longer to enroll than expected. Another is the dropout rate, which may be higher than expected resulting in the need to enroll additional subjects or run the study longer.
By identifying potential roadblocks like these upfront, you have a chance to think through contingency plans rather than being surprised and needing to respond quickly and risking a suboptimal resolution. If considered ahead of time, it is possible to identify a potential roadblock sooner and to fix it while it is a minor annoyance rather than a major problem requiring considerable time and expense to resolve.
The best way to avoid this situation is to have access to all study information at your fingertips and the opportunity to monitor potential roadblocks that have been identified during study planning. This essential visibility can only be provided if your study is being conducted on a technology platform that provides you and your CRO access to ongoing, real time study performance data.