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