Datatrial delivers a complete solution for collecting, managing and reporting clinical data through its electronic data capture suite featuring nowEDC™ and nowReport™. We believe that EDC can and should be affordable for all trials from early phase through to large Phase III as well as patient registries. We offer a cost-effective and scalable solution due to our quick study start-up, lower license fees and volume discounts. nowEDC™ is made up of a set of core modules which have been validated using the GaMP V-Model to ensure compliance with the FDA 21 CFR part 11 regulations. Our data collection solution was developed by an investigator who saw the need for an EDC system designed with the needs of the site user at the forefront. Even as the industry and electronic data collection methods have become more sophisticated, Datatrial remains consistent with its commitment to advancing a system designed to benefit and support the site end users.
Collecting Data
• Web-based solution enables users to work from
anywhere
• User friendly and standardized Microsoft Windows
look and feel
• Intuitive design and simplicity for users
• Highly configurable, role-based data entry
and monitoring workflows
• Flexible navigation allows users to choose
between tree structure and grid system
• Easily identifiable icon system for standard
process management
• Data entry is completed utilizing check boxes,
drop-down menus and controlled free text fields
• Out of range data entered is flagged to the
user upon submission allowing for the correction of typographical errors immediately
• Ability to save partial or incomplete data
and disable edit checks until the
entry has been completed
Managing Data
• Intuitive query management system
• Protocol deviation notification and categorization
tool
• Real-time edit checks for point of entry checks
and batch checks at pre-determined intervals
• Source Document Verification can be conducted
per data point or per page
• Oracle® Thesaurus Management System integrated
with nowEDC™
• Easily link images, pictures and documents
to specific CRF pages
Reporting Data
• Reporting accessible through web-based interface
• Wizard-driven tool for easy report generation
and real-time access to data
• Over 30 standard reports for core study management
metrics
• Role-based and controlled access to data
• Create and store custom reports and graphs
with ease
• Data extract tool enables users to generate
real-time extracts in XML, CSV, Excel and Access
Knowledge Transfer Program
For customers that want to build and deploy their own nowEDC™ studies, Datatrial’s Knowledge Transfer Program offers flexible options to help our customers achieve their clinical program goals. Datatrial will work with our customers to develop a plan that will enable them to become proficient at building, testing and deploying studies at a pace that takes into account the resources and skill sets available.
- Simple, spreadsheet-driven eCRF build
- Detailed training in study build, programming
edit checks, UAT and reporting
- Server hosting managed by Datatrial in our
Level 5 secure data center
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