The services of CRS-CDM in Grünstadt comprise

Study Planning

• Statistical input to clinical trial planning
• Sample size estimation
• CRF design, review, production
• Randomization
• eCRF design

Study Conduct

• Database set-up, design of data entry screens
• Double data entry with Oracle Clinical
• Data entry via internet connection directly into sponsor’s database
• Data validation, query management
• Medical coding (MedDRA, WHO, other dictionaries)
• CDISCStudy

Evaluation

• Evaluation according to ICH E9, statistical analysis plan
• PK / PD evaluation
• Interim analysis
• Equipment, infrastructure IT
• Standard software: Windows XP pro, Office 2003, Adobe Acrobat
• Data Management System: Oracle Clinical (Version 4.52)
• Sample size calculation: n-query Advisor
• Randomisation: Rancode
• Evaluation: SAS, Testimate, WinNonlin, StatXact8PROCs for SAS users
• CRF preparation: MS Word

The services of CRS-CDM in Grünstadt comprise All systems of Clinical Data Management are validated according to 21 CFR part 11.
The department is located in Grünstadt.