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Data Management & Bio-statistics
Clinexa has a skillful project team for Data Management and Biostatistics, who are well trained and experienced in GCP and 21 CFR Part 11. Our Data Management expertise performs the tasks starting from Protocol Design to Database Lock, following Standard Operating Procedures and Data Management Plans for excellent end results and for our client’s utmost satisfaction.

Our Biostatisticians are experienced for designing a study with complex statistical analysis plan. They deliver error free data and generate high quality reports for submitting to FDA, EMEA, DCGI etc. Our investigative site staff is well trained in generating superior quality data, which is one of the critical elements of clinical trials for our clients.

Our Data Management and Biostatistics team support our clients to navigate through the complex areas of study design, generation of raw data along with its integration and interpretation.

We offer the following data management & biostatistics services to our clients:
    Data Management:
    Case Report Form (CRF) and Database design
    CRF review
    Data validation plan (DVP), Edit check Procedures, Data management plan (DMP) design
    Quality control of database.
    Query management system / Discrepancy management system.
    SAE data reconciliation.
    External data administration and integration.
    Medical coding.
    Database freezing and locking.

    Bio-statistics :
    Development of study design.
    Sample size / Statistical power determination.
    Statistical inputs and Statistical analysis plans for protocols.
    Interim and final analysis strategies.
    Preparation of integrated clinical and statistical reports.
    Design tables, listings and graphs.
    Study randomization plans.
    Preparation of SAS coding for in-house projects.
    Preparation of SAS reports.

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