Standard System
Oracle Clinical™ version 4.0.3* is used for all BioCAB
projects and is fully supported by an in-house OC team,
which develops and maintains our clients’ data environments.
Therefore, all BioCAB client’s
data is processed, managed and exported from a validated
and tested 21 CFR Part 11 compliant system using processes
and procedures which meet GCP consolidated guidelines for
the capture, management and reporting of clinical trial
data.
Standard Process and Procedures
All system validation and testing, and all production
processes are documented with standard operating procedures
and work instructions detailing operational procedures.
Our proven standard processes and skilled work force allow
us to quickly and effectively build a database and process
our client’s data in a consistent and easy to understand
way. As the client continues to work with BioCAB
on subsequent projects, the client realizes additional quantifiable
cost and time savings in database development as a result
of procedural efficiencies such as client specific libraries
of standard CRF pages, edit check programs, and data structures.
The following is a diagrammatic representation of the BioCAB’s
standard system and processes.
*
Client Associated Businesses is currently upgrading from
Oracle Clinical™
version 4.0.3 to version 4.5 and expects to complete the
installation, validation and testing of 4.5 by June 1,
2005. This upgrade will allow us to offer our BioCAB clients
both paper CRF based and remote electronic based data entry
solutions.
