EDC systems for clinical trials have been in the market for many years; however, there have been a lot of changes in clinical trials in just a few years. A couple of decades ago, paper-based data was the only way to store essential medical information and clinical research data. Today, electronic data capture (EDC) software, electronic devices, and electronic health records (EHRs) are the primary sources of the same data.
The emergence of different coronavirus variants is making clinical trials even more challenging for pharmaceutical companies trying to collect data and visit patients from afar to stay safe.
Here’s a valuable insight into whether the EDC technologies have been able to keep up with clinical trials:
1. EDC systems for clinical trials and Current Clinical Research
Even though EDC is a significant development over paper-based clinical documentation, clinical trials have become much more complicated as data collection increases significantly.
Doctor checking Clinical EDC Data to Paper-based CRF
It’s challenging for a clinical team to use current EDC systems because many different data sources and types exist. Most EDC systems were suitable to work with structured electronic forms.
These systems could not handle unstructured data sourced from sensors and wearables. They were also incapable of collecting extensive data, dealing with several different data sources, and compiling them in one place. These problems with EDC systems make it very hard and time-consuming to retrieve clinical trial data in an organized and easy-to-understand form.
2. How Should EDC Change?
Previously, vendors made clinical trial software that worked in a specific manner. Clinical teams had to determine how their protocols would work with these systems, and this was a lot of work. This method makes setting up a clinical trial challenging and costly.
A powerful way to help clinical research is to mine EHRs for valuable data. It’s not very easy to do this with today’s clinical trial systems. EHRs used to find patients who qualify for a particular study can also determine their location.
3. Oracle’s Clinical One
Oracle came up with a platform called Clinical One to meet clinical trials’ current and future needs. With Clinical One, study teams don’t have to figure out the systems needed to run a trial, the software provided by each vendor, and the procedure of connecting all the systems. Instead, they enable the functions required to run a specific clinical trial.
The platform brings them together to work seamlessly, and there is a single clinical trial workflow. This minimizes the money and time it would take to connect these systems.
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