Clinical trials are becoming more complex. Technology is allowing researchers to collect data from more sources than ever. Both technology and process innovations are giving researchers the flexibility to expand the kinds of data they collect, leading to the addition of new endpoints to prove the efficacy and safety of therapies and data that helps to differentiate medical products post-release. While these are all positive changes, they do serve to significantly increase the amount of data that needs to be sorted and analyzed. To answer this challenge, research teams turn to solutions that allow them to more easily manage the influx of data and its management. Chief among these solutions are electronic data capture (EDC) systems.
EDC systems are increasingly common in clinical research, but there are still some who maintain the use of older methods like pen and paper or simple spreadsheets. It can be difficult for many to shift gears after performing their jobs in a certain way for a long period of time. With advances in data collection approaches popping up more and more quickly, it won’t be long before those older methods for data collection and management just aren’t sufficient.
Following are three key benefits to implementing an EDC system to help decision-makers navigate a transition away from the old-school methods or to help those already using an EDC platform to discover even more value.
1. Enhanced Efficiency and Data Accuracy
Whether for small, early-phase studies or later-phase, global trials with hundreds of participants, EDC platforms make data collection more streamlined and efficient. EDCs can be configured to automatically capture and store information from a broad range of sources including patient outcome assessments, patient medical records, labs, medical devices, wearables, and more. This process automation eliminates hours of tedious manual data entry while protecting data accuracy. After all, reduced manual data entry means much less room for human transcription errors. Automation also enables study teams to work smarter, spending less time on low-level administrative tasks and more time on patient engagement or applying the insights gleaned from the study data to drive better outcomes.
Getting started doesn’t need to be overly complicated, either. EDC solutions exist that require little to zero coding experience from study team members. Through easy to use, plug-and-play interfaces, they can quickly build out a study themselves. This also supports the ability to seamlessly make changes over the course of the study without the added cost and timelines associated with bringing in third-party vendors.
2. Enhanced Security
One of the reasons that some have been slow to adopt EDC solutions is the perception that paper methods may be more secure. Anyone who’s ever lost a wallet or concert ticket can tell you that hard copies offer zero inherent security. With EDCs, data is collected and stored securely within an encrypted cloud-based architecture. This means that data is always available and always safe. Further, the cloud-based architectures can be configured to meet or exceed all relevant regulatory requirements, including those from multiple different regional bodies with their own sets of rules.
The best EDC solutions even allow for mobile access, assisting to keep study team members connected to the study in case issues arise “off-the-clock.” This level of secure, easy access can be the difference between quick problem-solving and costly slowdowns.
3. Enhanced Access to Data
Perhaps the most useful benefit of EDC platforms is the access to study data they provide research stakeholders. The platforms can be built with strict rules and permissions that allow each study team member to easily get the information they need, and only the information they need. No member of the team needs to hunt down a file folder. Days of email back and forth are not needed to determine who needs which record. Problems cannot occur because a spreadsheet was incorrectly shared with someone (Oops, I sent that to Mary B. instead of Mary A.!), resulting in noncompliance.
Additionally, EDCs can allow study team members to access the data they need around the clock from wherever they are. The best EDC solutions even allow for mobile access, assisting to keep study team members connected to the study in case issues arise “off-the-clock.” This level of secure, easy access can be the difference between quick problem-solving and costly slowdowns.
There are certainly other reasons for adopting a user-friendly and secure EDC platform. To learn more about how to get started or to maximize the value of EDC for your clinical trials, visit www.crucialdatasolutions.com
