Data Management and Statistical Analysis

From the quality standard, industry experience in both US and China, to use of multiple EDC systems, CR Medicon's data management and statistical service is a leader in the CRO industry. Our team strictly implements the CDISC rules, follows the GCP standards and our internal and client's SOP workflows. We are the expert in designing custom solutions based on sponsors' requirements. From protocol design to the entire project management, CR Medicon provides flexible and convenient services that ensure smooth and unobstructed communications between regulatory authorities and researchers. Our core members all came from well-known China and international pharmaceutical companies and global CRO providers. With our extensive experience in Phase I-III international multi-center and clinical registration trials, our clients have access to the most accurate, timely and reliable clinical trial data management and statical analysis services.   

Services

  • Data Management
    • Case report form (CRF, eCRF) design
    • Randomized trial and drug supply system design
    • Database design, build, test and maintenance
    • Double data entry and comparison of paper-form data
    • Data verification and validation management
    • Medical coding, SAE consistency verification, external data management
    • Quality assurance and data management audit
  • Statistical Analysis
    • Clinical trial design
    • Sample size calculation
    • Clinical trial protocol drafting
    • Statistical analysis plan drafting
    • Randomized trial plan drafting
    • Creation of data set conforming to CDISC SDTM/ADaM standards and analysis
    • SAS programming
    • Sensitivity and exploratory analysis
    • Interim analysis
    • Data Monitoring Committee (DMC) related statistical activities
    • ISS/ISE analysis
    • Generating statistical analysis reports

Advantages

  • Our US-China team consists of nearly 90 members, most of whom have over 5 years of industry experience. Our core team members are experts in the field, each with 10-20 years' of life-time experience. 
  • Extensive Phase I-III, BE, real-world data management and statistic experience; Extensive US-China dual registration project management and submission experience. 
  • Experienced in using multiple EDC systems, including Rave, BioKnow, Taimei.
  • Certified partner of Medidata, the largest EDC system provider in the world.
  • Standardized data coding according MedDRA and WHO Drug
  • Extensive experience in CDISC standard implementation
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