Clinical Data Management & Biostatistics

Our departments of Clinical Data Management and Biostatistics work closely together. As a CDISC Gold Member, we comply with the CDASH, SDTM and ADaM standards. We have developed our own adaptable SAS-based Data Management System and we are prepared to work with project-specific EDC and DM systems. Whether your study requires standard statistical analyses or involves complex methodological issues, we are committed to develop customised solutions which meet your research goals. We have expertise in developing, validating and applying biometric tools within a variety of study designs and statistical approaches.

Clinical Data Management Services:
• Case Report Form (CRF) Design and Printing, and/or eCRF setup
• CRF Annotations and Database Specifications
• Database Design
• Creation of Data Management Plans and Edit Check Specifications
• PK and SAE Reconciliation
• Data Validation and Query Management

Clinical Data Management Tools:
• EDC (web-based data capture for Phase I, II, III, IV, and post-marketing studies)
• System for capture of hardcopy data (SAS-based, paper or fax-transmitted)
• Query system (SAS-based, handling of automated and manual queries)

Coding-Related Services:
• Development of trial-specific routines
• Training
• Code-driven data validation
• Review and validation of legacy codes or codes provided by a third party

Statistical Consulting:
• Sample size estimation and power calculation
• Statistical consulting regarding study design and study protocol

Biostatistical Planning and Analysis:
• Statistical analysis plan and randomisation
• Statistical evaluation (phase I – IV clinical studies, data overviews, interim-analysis, meta-analyses)
• Pharmacokinetic and pharmacodynamic analysis
• Report preparation