Data management and biostatistics

 

Our team has over 10 years of experience in delivering expert data management and biostatistics solutions. We offer 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 Pharma is able to deploy the very best in niche capabilities on a study by study basis. 

Our experience

Experienced in all phases of clinical trials (Bioequivalence studies, Phase I-IV, Postmarketing (Observational) Studies) and registries (Interventional and Non-interventional), in wide range of therapeutical areas
Experienced in the most popular EDC systems such as Oracle Clinical, Medidata Rave, Medrio, Viedoc, Marvin, RedCAP, Castor, MedNET, OpenClinica (ClinCapture

What we offer

Study-specific Database setup and update (if required) based on eCRF/ECM specifications.

Central monitoring using data analysis software like SAS, R, SQL-based apps. 

Full cycle of Data Management and Biostatistics documents workflow in terms of: 

  • Study-specific validation package, 

  • Data Management Plan, 

  • eCRF and edit checks (ECM) specifications, 

  • Data Validation Plan, 

  • Account Management, Data Transfer, Data Import and Database Freeze/Lock procedures, 

  • Data Review Meetings Report/Minutes as well as Interim/Final Clean File, 

  • Randomization Specification and Randomization Schema, 

  • Statistical Analysis Plan incl. TFLs shells (Data Display Plan), 

  • Statistical Analysis Report, 

  • Statistical Programming Validation procedure, etc.

  • Case Report Form (CRF) development/validation.

Accomplish different randomization approaches like blind/unblind procedures without or with any number of stratification criteria

Query Management based on implemented automatic edit checks, manual data review, summarized data central monitoring

Semi-automatic Data Coding using MedDRA and WHO-DRUG dictionaries 

Data Reconciliation with External Sources (Safety Data Reconciliation with PV Database, ePRO data reconciliation, etc.)

Biostatistical service oversight in terms of sample size calculation, statistical planning and reporting, SAS programming (TFLs, SDTM and ADaM datasets)

 Clinical Trial Data Management

  • Customized database design/validation
  • Data entry screen design/validation
  • Double data entry
  • Programming under SAS
  • Data coding
  • Data validation (manual check, computerized edit checks, medical expertise) 
  • Data listings 
  • Presenting data in the format & structure convenient for the client                                         
  • Data transfers 

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 by emailing bd@cromospharma.com.