No two clinical trials are alike. As there are thousands of trials underway at any moment, that means there are thousands of ways a trial might unfold —and thousands of ways things might go wrong. Among the worst are those that threaten the quality of the data. After all, a trial can’t deliver results if the data are suspect.
For that reason, a clinical data management system (CDMS) is essential for every clinical trial that aims to collect and analyze data properly, and produce acceptable results.
A successful trial requires an organized, over-arching approach to data collection, starting when the study questions are being defined and ending when the final study report is accepted. A CDMS ensures that all of the steps between those two endpoints are considered and properly executed. Conducting a trial using something like an Excel file just won’t cut it.
Remember that data strategy is fundamental, and needs wiggle room.
Beware of basing your data strategy on a pre-conceived notion that either electronic or paper data collection is the only way to go. (There are investigators out there who are bent on requiring one or the other.) Reality isn’t that simple and a commitment to flexibility at the outset will serve you well when you find that limited connectivity is a fact of life at some of your sites or that a high-performing site is staunchly committed to paper. A DFnet team member shared this recollection of a less-than-flexible sponsor:
“They really, really wanted EDC, even though the infrastructure wasn’t there to support it. We suggested alternative strategies, but they insisted. We jumped through many hoops trying to get it to work. A CDMS was in place, but they should have used paper and then scanned and uploaded their data to the CDMS.”
DFnet optimizes clinical trials with faster setup, higher quality data, and greater flexibility. Sounds good, right? Let’s talk.
Work with an expert team you can trust every time.
As clinical data is a clinical trial’s greatest asset, sponsors should invest in a clinical data team with the proper experience and know-how to protect it at every step. Teams earn those credentials through years in the field working in diverse circumstances around the world. They have learned to be flexible, resourceful, and creative. The best CDMS could be described much the same way.
Consider DFdiscover, the DFnet CDMS, for example. It’s a comprehensive, hybrid CDMS that can seamlessly harmonize multi-source data – including EDC, paper, and multi-format attachments —and integrate them into a single platform. It’s fully compliant with HIPAA, GDPR, FDA 21 CFR Part 11 and is developed using ISO 9001:2015 certified processes. The DFnet CDMS eClinical software is designed by data managers and clinical trial specialists who know the complexity of research processes and the need for agile tools. As a result, it can handle any curve ball a trial might throw.
Our three-part advice.
To summarize our advice to sponsors who hope to run a successful trial, check the following three boxes at the outset when it comes to data collection:
- Be prepared.
Consider all your sites, their strengths and weaknesses and inclinations, as well as other factors that might affect their performance.
- Be flexible.
Remember that good data is the end goal. Whatever technology it takes to get there is fine.
- Secure expert, reliable support.
There are “quick and easy” approaches to clinical data management, but they involve substantial risks and inconveniences. Work with professional systems backed by experts.
What’s your approach to clinical data management?
Is your data strategy solid? Can your CDMS handle whatever challenges your trial might face in the weeks and months ahead? At DFnet, we have more than 20 years of experience in providing research teams with the security and peace of mind they need to proceed with confidence anywhere in the world. Let us know how we can help you.
To learn more about DFnet, and how we might help you with your clinical trials, reach out to us at email@example.com.