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

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