Services

CRM Biometrics GmbH offers in detail:

Data management

• CRF Review and/or generation
• Database setup with DMSys®* (generation of database, generation of data entry screens, generation of edit checks)
• Setup of study-specific database for tracking study specific information (including CRF tracking, Queries, status reports)
• Development of Data management plans
• Coding of medications, diseases and adverse events (MedDRA, WHO Drug Reference List)
• Double data entry
• Query management
• Database transfer to SAS
• Final data-quality checks
• Maintain audit trail (paper and electronic)

* DMSys® is 21 CFR Part 11 compliant

Statistics and Reporting

• Statistical parts of study protocols
• Sample size calculation
• Generation of randomisation list
• Generation of emergency envelopes
• Development of Statistical analysis plans
• Data analysis (Generation of listings, tables and figures, confirmatory analyses)
• Biometrical reports
• Integrated Clinical trial reports according ICH E3 guidelines
• Statistical parts of study reports and publications

FULL Service CRO
CRM Biometrics GmbH offers the complete range of a full-service CRO including monitoring with internal and external quality assurance in cooperation with CRM clinical trials GmbH (www.crm-ct.de).