Mediolanum Cardio Research
            
    DATA MANAGEMENT and STATISTICS

    Design Database
    Perform Single Data Entry
    Perform Double Data Entry
    Data Monitoring and Auditing
    Queries Generation

    Database Lock
    Randomization
    Sample size calculation
    Interim and Final Statistical Analysis

  • A qualified staff of experienced data managers can develop databases according of protocol specificities and Sponsor's requirements.

  • They work under the supervision of a senior Service Responsible and in collaboration with the Project Leader to assure timely management of collected data.

  • In a complex trial, 24-hour telephone service staffed by medical and computer experts may also be established to answer medical or technical questions from the investigator site.

  • The Statistical personnel in MCR have extensive experience in data analysis from clinical trials and can provide interim analysis, final analysis and stopping rules. The statistical staff is involved in all trial design, including protocol design, CRF development, and data management.
<< BACK