Cromos Pharma offers a full range of clinical data management and biostatistics services utilizing internal teams as well as long-established, trusted alliance partners from the European Union and USA. The use of internal as well as outsourced resources ensures that Cromos is able to deploy the very best in niche capabilities on a study by study basis.

Clinical 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


Biostatistics

  • 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 beginning of 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
    • If you are interested in outsourcing clinical data management and biostatistics services, please contact our Business Development team.