Data Management Services | intellignet-ct

Intelligent data capture backed by the experience of running some 800 phase I - IV clinical trials
Streamlined / optimized data management processes characterized by higher quality coming at lower cost
Continuous data review and trending to identify and correct logical errors
Preventing mechanical errors or containing error sources with the Automated Navigator, double data entry and and VVE (Valid Value Edits)
Build study protocol into the iEDC data entry application that will guide clinical personnel into capturing clean data
Set up new clinical trial studies sql server database systems, testing and validation

Safety review and 100% cleaning of primary endpoints variables
Quality assurance - determination of error rate, and generating the FDA required Quality Certificate
Coordination with Central laboratories
Incorporation of Electronic Data e.g. laboratory results
Electronic database transfer e.g. ASCII, SAS® datasets (9.1) and/or transport files
Generating the double Electronic audit trail (field and form level)
Dictionary implementation and maintenance
Medical coding of adverse events (AEs), diseases and medication using MedDRA, WHO DRL / ATC or Sponsor specific thesauri
Automated AE & SAE Reconciliation

Intelligent data capture backed by the experience of running some 800 phase I - IV clinical trials