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An accurate, informative and easy-to-understand presentation of your clinical data, including complete traceability, depends on sophisticated statistical programming. We understand your needs and applies state-of-the-art industry practices to ensure regulatory compliance and facilitate regulatory review of your data. Our programming environment includes Good Programming Practices (GPP) and up-to-date standard procedures for program development and validation.
By leveraging our domain and business expertise, we offer highly skilled programmers with extensive experience in:
- Data preparation and programming of tables, listings, and graphs or figures (TLG/TLF)
- Data integration for pooled analysis
- CDISC data conversion and consulting
- Regulatory submission support
- Data preparation for pharmacokinetics analysis
- Data preparation for modeling and simulation
- Graphical patient profiles
CDISC Data Conversion
CDISC standards provide guidance for the whole data management and analysis process, from data capture to creation of datasets for subject tabulations and analysis.
We offers extensive expertise in converting clinical data to SDTM and ADaM standards. We also perform cross checks to ensure consistency between your study report and the converted data.
When it comes to data preparation and programming, you’ll benefit from our high standards and personal touch. For analysis of your clinical data, our expert statistical programmers will develop programs for tables, listings and graphs or figures (TLGs or TLFs) following our Good Programming Practices.
Data preparation and analysis program generation follow a software development lifecycle within dedicated development, validation and production environments. Our SOPs ensure output of the highest quality and reliability.
The integration and pooled assessment of clinical data across multiple studies can accelerate regulatory review of your product by providing an insightful overview of safety and efficacy. Our statistical programming professionals have extensive experience in the art of clinical data integration.
Detailed project planning ensures that the process from designing an integrated database through to validation of mapping programs is completed in time for your submission.
No matter what formats and clinical databases were used in your clinical studies, we can combine them into a standardized, integrated database and provide expert statistical programming for pooled analysis according to your needs.