Shanghai Chengxi Pharmaceutical Technology Co., Ltd., established in January 2012, is a professional data statistics company founded by industry veterans. Chengxi is dedicated to providing specialized services for clinical research to pharmaceutical companies, Contract Research Organizations (CROs), and medical institutions. The core members of the company's departments all have over ten years of experience in the industry. They have undertaken various projects for both foreign and domestic pharmaceutical companies, ranging from Phase 1 to Phase 4 studies, as well as investigator-initiated and survey research. These projects cover a wide range of fields, including cancer, cardiovascular, respiratory, digestive, endocrine, neurological, anti-infection, and transplantation. Chengxi offers services in data management, statistical programming, and biosestatistics, with an experienced team that can provide CDISC-compliant data management and statistical analysis services. Committed to delivering high-quality services that meet client requirements within limited timeframes and budgets, Chengxi Pharmaceuticals strives to excel.
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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.
