At the core of our data management are InterTrial and Oracle® OC/RDC, both fully integrated electronic data capture systems that combine 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® / Oracle® 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 the data source for project status reports, Switching pCRF vs. 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)

Our capabilities include: Study design phase I – IV, Sample size calculations, Statistical methods applications, Review of entire protocols and statistical parts, Randomizations, Statistical programming, e.g. descriptive statistics and univariate analysis, linear and nonlinear models, categorical data analysis, Interim analyses, Statistical Analysis Plans, Statistical programming (SAS®), Integrated safety and efficacy analysis Clinical study reports: tables, figure, listings, bookmarked and hyperlinked