It’s not uncommon for clinical project managers to generate a regular status report for each of their ongoing studies. What’s more common, unfortunately, is the cumbersome way they go about it: collecting clinical trial data from study managers, entering it into an Excel spreadsheet, and running countless calculations – the process can be highly labor-intensive. And, I’m not even taking the formatting of the document into account! Without question, this manual process can prevent a company from having real-time insight into their studies.
One alternative to this slow and painful method of developing a status report is to implement a summary report module directly in your clinical trial management system (CTMS) that can automatically produce metrics on your trials in real-time. Such a module can include study metrics, CRF metrics, baseline and actual comparisons, and enrollment forecasting. A report like this generated from your CTMS can make it easy for a clinical project manager to identify and respond to issues and trends. But, perhaps most importantly, this kind of real-time summary report can make your boss VERY happy.
Having the ability to automatically generate a clinical trial summary report in a CTMS supports:
- Improved Data Quality: Because some of the data is automatically populated and several of the calculations are automatically performed, the quality of the data is more reliable. Additionally, if your
CTMS is validated, there’s another reason you can trust the calculations and reference them at any time in the documentation, unlike with the spreadsheet.
- Real-Time Access: Since multiple users can enter/update data at any time and the report can be generated at any time, you’ll have real-time insight into the progress of studies and can respond more quickly if changes are needed.
- Increased Efficiency: Thanks to the automatic collecting and calculating of data, there is less manual work to do, and there is also no longer a bottleneck around generating the report. Senior management can generate a progress report at any time.
- Cost and Time Savings: Having less manual work to do around this tracking and reporting can allow you to accomplish more without needing additional resources. Also, having the report incorporated into a CTMS means your company has fewer tools to maintain and support.
If you’re interested in evaluating a CTMS or adding a summary report module to your existing CTMS, please let us know.
