Traditional, paper-based methods for clinical
data collection and management significantly reduce the
speed and efficiency of clinical personnel and impede the
progress of trials. From initial data capture, entry, monitoring,
query management and report generation - all the way to
the final regulatory submission - paper can delay the clinical
development continuum.
Paper-based data management also extends
the processes of data monitoring and cleaning. Because data
is manually entered in batches, queries are often generated
months after the data was captured, making real-time clinical
monitoring nearly impossible. In addition, data must be
checked against source documents at the site, which requires
time-intensive review and substantial travel for monitoring
personnel.
By integrating electronic data capture functionality
with automatic edit checks, real-time data queries, and
a complete audit log, Acceliant Data Management provides
the tools needed to efficiently manage trial information.
And although a paperless clinical development environment
may be your eventual goal, the Acceliant Data Management
module helps your organization to gradually and seamlessly
integrate electronic data capture and traditional paper-based
processes. There is no need to choose between EDC and paper
- Acceliant Data Management is the only proven solution
that enables your organization to run EDC, paper-based,
and hybrid trials.
Acceliant Data Management enables the immediate
data entry and automated edit checks for typographical errors
or out-of-range responses, substantially reducing the number
of subsequent queries. Because data is entered in real time,
site personnel are familiar with visit details and are able
to provide rapid query resolution. The Acceliant Data Management
module also provides robust data history and an automatically
generated audit log for FDA-compliant "paper trail"
management.
The Acceliant Data Management module includes
an eCRF creation tool, Designer Work Bench, the industry's
simplest drag and drop graphical tool that enables all-level
users to design case report forms, create data validation
rules for automatic edit checks, define code or decode lists,
and automatically configure underlying database schema corresponding
to each form.
