Cromos Pharma offers a full range of clinical data management and biostatistics services utilizing our internal team, as well as long-established – trusted alliance partners – from the European Union and the US. The use of internal as well as outsourced resources, ensures that Cromos Pharma can deploy the very best in niche capabilities on a study-by-study basis.
Clinical Trial Data Management:- Case Report Form (CRF) development/validation
- Customized database design/validation
- Data entry screen design/validation
- Double data entry
- Programming under SAS
- Data validation (manual check, computerized edit checks, medical expertise)
- Data listings
- Presenting data in the format & structure convenient for the client
- Data transfers
- Data coding
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Biostatistics through partners: - Fully compliant with CDISC/ADaM data standards
- Study design consultation
- Study protocol development
- Informed Consent Form preparation
- Sample size calculation
- Randomization code list generation
- Statistical analysis plan development
- Statistical analysis programs development and validation
- Statistical analysis conduct
- Programming of SDTM datasets at the beginning of a study, to assist in analysis
- Generation of reports from appropriate analytical tools, to assist RBM and QC of study data
- Generation of customized tables, graphs, and data listings
- Statistical interpretation of study results
- Mining of study results descriptions in medical narratives
- Study report writing
- Assistance in preparation of study results for presentations
- Assistance in manuscript preparation
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