Biostatistic and data-management

Icon, clinical trials in central & easter europe

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

 

 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

Cromos Pharma has over 18 years of experience in managing all aspects of clinical trials across a range of therapeutic areas. With operations in the US, Central and Eastern Europe we combine global expertise with profound local market knowledge to deliver end to end solutions supporting our pharma and biotech clients.

TO FIND OUT MORE

INQUIRY@CROMOSPHARMA.COM