Statistical Programming
Harness the power of data with our expert statistical programming services. Our skilled team excels in transforming raw data into meaningful and actionable results. With meticulous attention to detail and adherence to industry standards, we provide comprehensive statistical programming solutions that meet the specific requirements of your projects.
Our statistical programming services include:
CDISC Submission Packages
We specialize in CDISC submission packages, ensuring your data is organized and presented in compliance with regulatory requirements. From SDTM aCRF (annotated Case Report Form) annotation to the preparation of datasets, define.xml files, and reviewer’s guides, we streamline the submission process for your clinical trials.
aCRF Annotation
Our statistical programmers are experienced in aCRF (annotated Case Report Form) annotation, which involves mapping the data collected in electronic or paper CRFs to the corresponding SDTM domains and variables. With meticulous attention to detail, we ensure accurate and comprehensive mapping, allowing for smooth data integration and analysis.
SDTM and ADaM Specification
We develop clear and comprehensive specifications for SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) datasets. These specifications ensure consistency, compliance, and efficient data analysis.
Development and Validation of SDTM and ADaM Datasets
We create SDTM and ADaM datasets based on your study data. Our team performs thorough validation to ensure accuracy and compliance with CDISC (Clinical Data Interchange Standards Consortium) standards.
Conversion of Legacy Data to SDTM and ADaM Standards
If you have legacy data in non-standard formats, we can convert them to SDTM and ADaM standards, ensuring seamless integration and compliance with industry requirements.
CRT Package/ Data Exchange
As part of our statistical programming services, we provide expertise in CRT Package/ Data Exchange. We assist in developing and delivering SDTM Define.XML, ADaM Define.XML, and other components required for efficient data exchange and regulatory submissions.
Tables, listings, and figures (TLFs)
Our team can develop TLFs that are compliant with regulatory requirements and industry standards. We can also develop and document programming specifications to ensure reproducibility and traceability.
