• Business Areas

    Data Management

    Tigermed Biometrics team, numbering 400+ globally, operates in Shanghai, Jiaxing, Wuhan, Taiwan China, Korea, India and US New Jersey. With the well-established quality management and SOP system, we are dedicated to provide high quality and professional Data Management and Biostatistics services to support clinical development and regulatory submissions.

    Data Management: Clinical data management services for EDC and Paper study in various therapeutic areas

    ?           Data management consulting and training

    ?           CRF design

    ?           Database setup and testing

    ?           Data management plan development

    ?           Data validation plan development

    ?           Edit check programming and testing

    ?           Double data entry and comparison

    ?           Electronic and manual data review 

    ?           Query generation and resolution

    ?           Medical coding

    ?           SAE reconciliation

    ?           External data handling

    ?           DM TMF Management

    ?           DM progress report

    ?           Blinded data review

    ?           Database lock

    ?           Data extraction and transfer

    ?           Data management report development

    ?           DM final deliverables

    Biostatistics: Full range services of clinical trial design, analysis, interpretation and reporting

    ?           Provide statistical support for interaction with regulatory agencies

    ?           Clinical trial design and consulting

    ?           Statistical input to protocol development

    ?           Sample size/power estimation

    ?           Randomization schedule

    ?           Statistical analysis plan

    ?           Tables, Figures and Listings (TFLs) shells

    ?           Statistical analysis report

    ?           Statistical input to clinical study report

    ?           Provide statistical support for regulatory submissions

    ?           Provide statistical support for manuscripts and publications in various therapeutic areas

    Statistical Programming: One-stop comprehensive Statistical Programming service, especially for CDISC implementation and eSubmission

    ?           Analysis Datasets production and validation

    ?           TFL production and validation

    ?           CDISC implementation: aCRF, SDTM, ADaM, Define (pdf and xml), legacy data conversion

    ?           eSubmission

    ?           Integrated summary of efficacy and safety (ISE/ISS)

    ?           Statistical Programming support for Interim analysis and Data Monitoring Committee (DMC)

    ?           Statistical Programming support for manuscripts and publications in therapeutic areas

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