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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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