Statistical Programming and Analysis Services
Statistical Programming and Analysis Services
"Clinical trials generate vast amounts of data, spanning multiple phases, sites, and diverse patient populations. Turning this complex, multi-dimensional data into clear, trustworthy evidence requires specialized expertise in statistical programming and analysis."
In today’s rapidly evolving clinical research landscape, the role of Statistical Programming and Analysis within Contract Research Organizations (CROs) is more critical than ever. It bridges the gap between raw clinical trial data and meaningful insights that drive regulatory decisions, accelerate drug development, and ultimately improve patient outcomes. At Weltrix, our Statistical Programming and Analysis services are integral to delivering high-quality, timely, and compliant clinical research support that meets the complex demands of sponsors worldwide.
Statistical programmers transform raw data into standardized analysis datasets following industry norms such as CDISC’s SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model). Statisticians further analyze these datasets to answer critical research questions by applying appropriate statistical methods and models.
Comprehensive Statistical Programming Services
Weltrix’s Statistical Programming team delivers end-to-end programming support tailored to the specific needs of each clinical trial.
Our Services Include:
1. Dataset Creation and Validation: We develop standardized, submission-ready datasets (SDTM and ADaM) that form the foundation for reproducible analyses. Our process involves rigorous programming, validation, and documentation to ensure data integrity and regulatory compliance.
2. Analysis Dataset Development: Once raw data is curated, we create analysis datasets optimized for specific statistical methods. These datasets enable statisticians to conduct hypothesis testing, subgroup analysis, safety evaluations, and efficacy assessments with clarity and precision.
3. Generation of Tables, Listings, and Figures (TLFs): Statistical programmers utilize advanced software such as SAS and R to produce high-quality TLFs required for clinical study reports (CSRs), regulatory submissions, and presentations. These outputs provide critical summaries and visualizations of treatment effects, safety profiles, and patient demographics.
4. Automation and Efficiency: To accelerate project timelines and reduce errors, we implement automated programming pipelines and reusable macros that enhance consistency and efficiency across study deliverables.
5. Legacy Data Conversion: For programs with historical data in older formats, we specialize in converting legacy data to current regulatory standards, enabling integrated analysis across multi-study submissions.
Advanced Statistical Analysis Expertise
Our experienced statisticians bring deep methodological expertise and therapeutic knowledge to the analysis of clinical trial data:
Study Design Consulting: We advise sponsors on statistical aspects of study design, including sample size calculations, randomization methods, and adaptive designs that optimize trial efficiency and power.
Hypothesis Testing and Estimation: Our statisticians perform rigorous statistical hypothesis testing to evaluate treatment effects, non-inferiority/superiority assessments, and dose-response relationships in line with regulatory guidance.
Modeling and Simulation: Utilizing pharmacokinetic/pharmacodynamic (PK/PD) modeling, population modeling, and simulation techniques, we help characterize drug behavior and optimize dosing strategies.
Interim and Safety Analyses: We conduct interim analyses for Data Monitoring Committees, providing timely safety and efficacy updates that may influence trial continuation decisions.
Integrated Efficacy and Safety Summaries: Our team produces comprehensive integrated summaries that synthesize data across multiple studies, facilitating regulatory review and labeling strategies.
Real-World Evidence and Exploratory Analyses: Beyond traditional trials, we incorporate real-world data and exploratory statistical methods to generate additional insights supporting product lifecycle management and health economics assessments.
Quality Assurance and Regulatory Compliance
In an industry governed by strict regulations, data quality and compliance are paramount. Weltrix adheres to current Good Clinical Practice (GCP) guidelines and international regulatory requirements from agencies such as the FDA, EMA, and PMDA: Independent Validation, Audit Trails and Documentation, Data Privacy and Security, Regulatory Submission Readiness.
Clinical Programming
Site selection, patient recruitment, investigator oversight.
Regulatory Affairs
Submission planning, with ICH-GCP, DCGI, and FDA norms.
Biostatistics
Includes EDC systems, analysis, reporting, and clinical study documentation.