AT THE CORE OF OUR DATA MANAGEMENT IS INTERTRIAL,
THE FULLY INTEGRATED ELECTRONIC DATA CAPTURE SYSTEM,
AUDITED AND INSPECTED, WHICH COMBINES DATA CAPTURE
ON-SITE WITH STATISTICAL ANALYSIS, PHARMACOVIGILANCE
AND REPORTING.

We are specialized in rapid and efficient programming of the clinical
study database, the eCRF and the pharmacovigilance database.
Data security, data cleaning, coding and programming follow the
highest standards. Data Management at Assign uses state-of-the-art
IT Technology to speed up the data management and analysis process.

TECHNICAL STANDARDS:
– Redundant MS Windows Server
– MS SQL Server® Database management system
– Double-redundant backup strategy
– Secured Internet access with Secure Sockets Layer 128 bits encrypted
– Secured access for sponsors

DATA PROCESSING:
– CRF design is based on extensive experience in many different
    therapeutic areas
– CRF online access for sponsor, CRAs and study management
– CRF is data source for project status reports
– Switch pCRF <-> eCRF is possible (per site)
– Ongoing data entry and data cleaning
– Data validation and ongoing query process on demand
– Online and offline checks
– Study-specific user manuals
– Hotline
– Coding in MedDRA, WHO Drug Dictionary, ATC
– Flexible for CRF design changes
– Close integration with analysis software
– Standardized export into SAS® (fully labeled)