The bioanalytical services provided by CRS are:

• Method Development
• Method Validation
• Determination of drug and metabolite concentrations in biological matrices
• GLP Bioanalysis of samples of preclinical and clinical studies
• ELISA
• Specialized in chromatographic bioanalysis and ELISA
• More than 300 validated assays
• Output capacity about 80.000 samples (results) per year
• GLP certified (last update NOV 2004)
• FDA inspected (DEC 2002)
• BfArM and AFSSAPS inspected (AUG 2003)
• 21 CRF Part 11 compliant

The services of CRS´ CDM in Grünstadt comprise: 

Study planning

• Statistical input to clinical trial planning
• Sample size estimation
• CRF design, review, production
• Randomization
• Design of data structures

Study conduct

• Database set-up, testing, documentation and maintenance, design of data entry screens
• Double data entry with Oracle Clincal
• Coordination with Central Lab, data transfer
• Tracking of CRFs, CRF pages and Queries
• Data entry via internet connection directly into sponsor's database
• Data validation (validation plan, programming in SAS or Oracle Clinical)
• Query management, study coordination
• Medical coding (MedDRA, WHO, other dictionaries)
• Quality control

Study evaluation

• Evaluation according to ICH, E9Statistical analysis plan
• Statistical programming and analyses
• PK/PD evaluation
• Interim analysis
• Statistical reports
• Evaluation according to CRS or Sponsor's SOPs
• Electronic data transferQuality control
• Scanning of CRFs