Clinical Data Management & Biostatistics
At ICRC-Weyer, Biostatistics and Clinical Data Management are working closely together in a flat reporting structure. As a Gold Member we intensively support CDISC and fully comply with the CDASH, SDTM and ADaM standards. We developed our own adaptable SAS-based Data Management System and are able to work in close connection with project-specific EDC and DM systems and solutions. 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.
Our company covers the following standard tasks:
Biostatistics
Statistical consulting regarding study design, study protocol
Sample size estimation and power calculation
Statistical analysis plan and randomisation
Statistical analysis for phase I–IV clinical and medical device studies
Data review and protocol deviation assessment
Interim-analysis and meta-analyses
Pharmacokinetic and pharmacodynamic analysis
Report preparation and review
Clinical Data Management
- 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
EDC Electronic Data Capture (web-based data capture)
System for data capture (SAS-based, paper or fax-transmitted)
Query system (EDC- and SAS-based, handling of automated and manual queries)
Coding
Development of trial-specific routines and training
Code-driven data validation
Review and validation of legacy codes or codes provided by a third party