Clinovo introduces another way to capture and manage data during clinical trials.
In the past, paper-based systems have been utilized to record this essential information. Today, electronic data capture (EDC) systems have emerged and can be used to capture and manage data during clinical trials—after which point it can then be presented to the FDA for approval. EDCs collect clinical trial data electronically, which is one potential solution for streamlining data processing.
According to research cited by Clinovo, approximately 20% of clinical trials are using EDCs worldwide, while the other 80% of clinical trials capture data on paper or in Excel spreadsheets.
“EDC systems have been around for a couple of decades,” said Glenn Keet, CEO of Clinovo. “To this day, you can still install some of the databases on your server. In recent years, however, there have been more cloud-based systems.”
Today, however, data entry have transitioned to being inputted via the computer and other technologies.
“The idea of EDC is to restrict data entry: to be invalid (if possible), to avoid trivial data capture, to be readable (since it’s recorded on the computer), and to have more complex rules that allow you to compare data across case report forms,” said Keet. “EDC can warn the user in real-time if the data is outside the normal range and it minimizes (or eliminates) source data verification.”
In the U.S., approximately 50% of clinical trials are captured on paper and 50% on EDC. Worldwide, 30% of clinical trials utilized EDC and 70% use paper. This largely due to FDA requirements, as they require certain formats of data that is submitted.
“Cloud-based products are the next generation and are being accepted within the clinical trial industry,” said Keet. “Clinovo and some of our other competitors are trying to get more studies into EDC by virtue of having cloud-based systems and do-it-yourself tools. We think that will tilt the 50% rate in the U.S. of who is using EDC systems.”
This article can also be found in the November/December 2015 edition.