ClinNav™ is Quanticate's own flexible Clinical Data Management / EDC system which is fully "21 CFR Part 11" compliant. As a fully web based system with a SAS® engine, data produced for each project can easily be incorporated into the statistical reporting process.
For paper-based CRF studies, the system offers some benefits that until now have only been seen in EDC studies i.e. review of data online and ability for study monitors to raise queries online if required. For EDC studies it offers one of the most cost effective solutions currently available.
Hybrid Studies
ClinNav™ allows data management for both Electronic Data Capture (EDC) and traditional paper CRFs. In addition, it also has the capability to support hybrid studies, combining both paper CRFs and eCRFs in the same trial
Database Design
Our design allows any type of data collection, as well as CDISC or sponsor defined naming conventions. The capability to develop a library of sponsor specific eCRF pages creates efficiencies when processing multiple projects.
Easy Navigation
Simple for site staff and CRAs to work with and includes patients status tracking. Instantaneous eCRF screen upload, irrespective of number of subjects and database size.
Easy eCRF design
"Drag & drop" interface allows screens to be built to mirror a paper CRF, as can the combination of
up-front and back-end validation checks. Typical timeframe of 4 weeks from protocol sign-off to eCRF being ready for user acceptance testing; less than this where we can leverage from a previous eCRF.
High Level of Security
Data uploads to a central server on a per page basis using 128-bit data encryption, so no data are stored on Investigator/Site PCs. Customisable access levels, individual user accounts and detailed audit trails guarantee security and ICH compliance of your data.
Comprehensive Reports
On-line instant access to real-time metrics, study status, safety reports and interim efficacy analyses facilitating the implementation of adaptive designs. This leads to less time spent at sites by monitors, more effective project management and quicker decisions by sponsors.
