PHARMACEUTICAL PROCESSING | NOVEMBER/DECEMBER 2015 17 n
n ELECTRONIC DATA CAPTURE n PHARMPRO.COM
install some of the databases on your server. In recent years,
however, there have been more cloud-based systems.”
In the past, someone had to make case report forms (on
Microsoft Word or a similar program), print out the forms,
make and distribute these booklets to sites, and then the
data was hand-written onto the forms. Problems to this
method of data entry could be something as minute as an
inability to read someone’s handwriting, to recording the
wrong date, to people who neglect to fill out every line—
which can prove to be very large problems down the road.
Then, once the data was collected, it had to be entered into
a database and verified to ensure that there were no errors
made during that process.
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 elimi-
nates) source data verification.”
In the U.S., approximately 50% of clinical trials are cap-
tured on paper and 50% on EDC. Worldwide, 30% of clinical
trials utilize EDC systems and 70% use paper. This is largely
due to FDA requirements, as they require certain formats of
data that is submitted to them.
“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.” n
Our spring loaded check valves are
assembled to your exact needs, ensuring
absolute precision and reliability. They
work like they should. Plus, most lead
times are less than one week. That’s what
makes Check-All® the only choice.
Manufactured in West Des Moines, Iowa, USA ; 515-224-2301 ; www.checkall.com Get me a Check-All®®.
When You Need Absolute Precision
CHECK-ALL® IS THE ONLY CHOICE
It’s More than a Check Valve
It’s a Check-All®