Clintrace™ Consulting and Validation Services - 2.x and 4.x Systems

Experience with Clintrace

CSS Informatics provides Clintrace configuration, customization and support. Over the past decade, we have worked with many pharmaceutical companies to improve and expedite drug safety reporting and complementary reporting and coding tools.

Our Clintrace experience is wide-ranging and has included projects such as: 

E2b electronic reporting
Import of safety data using E2b format
MedDRA implementation and upgrades
Conversion of legacy-coded data to MedDRA
Data migrations from systems like Oracle AERS and ARISg into Clintrace
Clintrace and Oracle version upgrades
System validation services

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Clintrace Services

We offer a wide range of services to support and enhance Clintrace operations.

We can provide:

User access management and privileges
Update Clintrace screens with custom fields or to improve data entry
Maintain code lists, approvals, synonym tables and other reference information
Refresh Clintrace parameter files to maintain system-wide standards
Implement real time, field level validation
Monitor case distribution for multi-site global synchronization of data
Monitor compliance metrics
Enhance audit trail access and reporting
Create, duplicate or integrate storage areas
Modify expedited reports to comply with new regulatory standards
Clintrace database administration such as performance tuning and growth planning
Other support services

All of these services can be provided through remote access to the Clintrace database.  We offer a Clintrace support package that provides Clintrace evaluation, planning and implementation with support services that are critical to data integrity and regulatory compliance.