CDISC-Compliant Statistical Programming
LinShutong provides CDISC-compliant statistical programming services, covering SDTM and ADaM dataset creation, Tables, Listings, and Figures (TFL) programming, and complete regulatory submission package preparation. Our statistical programmers are proficient in SAS and R languages, ensuring programming results meet FDA, NMPA, and other regulatory requirements.
We adopt standardized programming processes and strict quality control systems to deliver high-quality, reproducible statistical analysis results, helping your drug development projects successfully pass regulatory approval.
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Fully compliant with CDISC SDTM and ADaM Implementation Guides
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Support for both SAS and R programming platforms to meet diverse needs
Statistical Programming Services
Statistical Programming
Professional Statistical Programming Services
SDTM Dataset Creation
Transform raw data into regulatory-compliant SDTM datasets according to CDISC SDTM standards, including all required and recommended domains
ADaM Dataset Creation
Create analysis datasets compliant with CDISC ADaM standards based on SAP and statistical analysis requirements, supporting all planned analyses
TFL Programming
Produce regulatory-compliant Tables, Listings, and Figures based on SAP and Mock Shell, supporting CSR and regulatory submissions
Programming Standards
Develop project-level programming standards, including naming conventions, macro library development, and programming templates to ensure code quality and consistency
Programming Validation
Perform independent double programming validation to ensure dataset and output accuracy, providing complete validation documentation
Submission Package Preparation
Prepare complete eCTD submission packages, including datasets, Define.xml, annotated CRFs, programming specification documents, etc.
Why Choose Our Statistical Programming Services
Professional statistical programming team with rich regulatory submission experience, ensuring your data package passes review on the first attempt
Learn MoreTechnical Excellence
Proficient in SAS and R languages, familiar with CDISC standards, with extensive regulatory submission experience
Quality Assurance
Rigorous validation process, independent double programming, ensuring 100% data accuracy
Efficient Delivery
Standardized macro libraries and templates, mature project management, reducing programming cycle by 30%
Compliance Guarantee
Compliant with FDA, NMPA, PMDA and other regulatory requirements, 99% first-time pass rate for submission packages
Standardized Statistical Programming Process
Requirements Analysis & Planning
Review SAP and Mock Shell, develop programming plan, determine SDTM/ADaM mapping specifications, set up programming environment
SDTM/ADaM Programming
Create SDTM and ADaM datasets according to CDISC standards, develop reusable macro programs, ensure data consistency
TFL Programming & Validation
Create Tables, Listings, and Figures, perform independent double programming validation, ensure output accuracy
Submission Package Integration
Generate Define.xml, prepare annotated CRFs, integrate all submission documents, perform final quality checks
Statistical Programming Services FAQ
Our team is proficient in both SAS and R, the two mainstream statistical programming languages. SAS is the industry standard for clinical trials, and we use SAS 9.4 and above; we also provide R programming services to meet diverse client needs.
We adopt an independent double programming validation mechanism: after the first programmer completes the programming, a second programmer independently performs validation programming, and then the results are compared. We also have multi-layer quality control measures including code review and peer review.
Our team is proficient in all major CDISC standards, including SDTM IG 3.2/3.3, ADaM IG 1.2/1.3, Define.xml 2.0/2.1, CDISC Controlled Terminology, etc., ensuring submission packages fully comply with regulatory requirements.
Project duration depends on study size and complexity. Typically, SDTM programming takes 2-4 weeks, ADaM programming takes 2-3 weeks, and TFL programming takes 3-6 weeks. We provide detailed time estimates before project initiation.