Helpclin Data Service Co., Ltd., is committed to providing data management, statistical programming, biostatistics services faster to pharmaceuticals companies. With the professional and highly experienced team, the core member has more than 9 years of industry experience. Helpclin offers high-quality services in compliance with CDISC standards and the standard operating procedure (SOP). Helpclin is a good partner and provider of high-quality services within tight timelines and budgets.
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Documents development
(e)CRF design
Database setup, validation and go live
External (central laboratory) data management
Data double entry and correction
Third party auidt
Data quality control
SAE reconciliation
Medical coding
Database maintenance and access managements
Query Management
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Sample size calculations
Statistical sections of the protocol
Randomization plan
Statistical analysis plans/report
PK and PK/PD analyses
Safety data analyses
Meta analysis
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Analysis datasets specifications development
Derived datasets creation
Program Tables, Figures and Listings (TFL)
QA/QC the datasets and TFL
CDISC services (SDTM, ADaM and Define.XML)
Support eCTD submission
Patient summaries for narratives
Support data management
ISS(SCS)/ISE(SCE) analysis
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We have the systematic and completed SOP, and standardized SAS codes to deliver services faster, more efficient and cost-effective than ever thought possible.
The servers with the features of flexibility in resource acquisition, unified authentication, security & reliable, IP core protection and dynamic extensions, ensure data security.
The complete procedures of quality control guarantee the highest quality in all our services.
We are fully regulatory compliant with CFDA, FDA and other regulatory agencies.
