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        Data Management and Biostatistics

        Helpclin Data Service Co., Ltd., a data service company wholly-owned by Yongzheng, is committed to providing data management, statistical programming, biostatistics services faster, more efficient and cost effective than ever thought possible to Pharmaceuticals companies and Pharmaceutical Research & Development Organizations. With the no-nonsense attitude, the professional and highly experienced team of Helpclin Data Service Co., Ltd., offers the high-quality services in the compliance of the CDISC standards and the standard operating procedure (SOP). Based on the individual requirements of projects, Helpclin Data Service Co., Ltd. is a good partner and provider of high-quality services across the Phases I-IV and Bio-equivalence studies within tight timelines and budgets.

         

        Data Management

        The department head has worked for domestic/global CRO with 10+ years of industry experiences, who has been responsible/participated in over 50 projects. The core team has worked for domestic/global CRO with 6+ years of industry experiences, who have been responsible/participated in over 70 projects.

         

        Service Scope

        -    Data Management Related Documents Development

        -    CRF Design

        -    Database Design, Testing and Go Live

        -    Database Maintenance and Authorization

        -    Double Entry and Verify

        -    Query Management

        -    Data Quality Control

        -    AE Reconciliation

        -    Medical Coding

        -    External Data Management (central lab)

        -    Third-party audit


        SAS Programming

        The department head has over 10 years of programming experiences in Phase I~IV MRCT/domestic trials, who has good command of CDISC submission regulations including Define, SDTM, ADaM etc.. The core team has worked for domestic/global CRO with 5+ years of industry experiences, who have been responsible/participated in over 100 projects of Phase I~IV MRCT/domestic trials

         

        Service Scope

        -    Develop Analysis Dataset Specifications

        -    Create Analysis Dataset

        -    Create TLF

        -    Quality Control of Dataset TLF

        -    Calculate PK/PD Parameters

        -    ISS/ISE Analysis Dataset Delvelopment

        -    CDISC Service (SDTM, ADaM and Define)

         

        Biostatistics

        The department head is Ph.D of Biostatistics with over 15 years of industry experiences, has participated in many in Phase I~IV MRCT/domestic trials, studied in the Biostatistics Dept. of Yale’s for 1 year.


        Service Scope

        -    Protocol Design Consulting Statistical Review

        -    Sample Size Calculation

        -    Protocol Statistical Review

        -    Randomization

        -    SAP/SAR

        -    PK & PK/PD Analysis

        -    Safety Data Analysis 

        -    Meta Analysis

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