Flexible, Precise Data Management and Statistical Analysis Solutions
International standards, covering the entire clinical research process
SDM’s statistical programming team is proficient in multiple programming languages and follows clear workflows and standardized methods for data processing and analysis. With extensive experience in submitting data to regulatory agencies in various countries, our team uses highly automated tools for data interpretation and analysis. We work closely with other teams to provide decision support for clinical trial sponsors.
Our Expertise Includes:
• Innovative trial design in all modalities and experience in multiple therapeutic areas
• All phases of clinical trials from pre-IND to NDA to postmarket studies
• Standard templates for derived dataset specifications based on project experience
Are You Facing Any of These Challenges
NO
1
How to prepare data for submission in accordance with regulatory requirements;
NO
2
Whether the data quality required by the statistical analysis results meets the standards;
NO
3
After the original data collection is complete, the fields on the CRF form are uncertain to which SDTM domain should be mapped;
NO
4
After SAP finalized, not sure what structure analysis data set to use for analysis
Comprehensive Quality System
We ensure traceability of metadata from data collection to statistical analysis results by writing detailed specifications.
We employ a dual programming and manual review process to ensure programming quality.
We employ a dual programming and manual review process to ensure programming quality.
Experienced Team
SDM statistical programming team bridges the gap between clinical trial data management and statistical analysis, CDISC standards, programming languages and statistical analysis. This expertise helps improve efficiency in clinical trial data management and analysis while advancing data submission progress.
Learn more about SDM’s flexible, reliable and efficient data management and statistical programming solutions.
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