Data Management and Biostatistics
Ensuring data integrity, analytical rigor, and regulatory confidence.
Our Data & Biostatistics Capabilities : Independent quality checks and regulatory-aligned processes.
At Catalyst Clinical Services, our Data Management and Biostatistics services are designed to deliver clean, consistent, and audit-ready datasets that support reliable decision-making and high-quality regulatory submissions. Our integrated approach ensures accuracy, traceability, and compliance across the entire data lifecycle—from collection to final analysis and reporting.
Clinical Data Management
- Standardized data collection using structured paper CRFs to ensure uniformity across sites
- Accurate and complete data entry into a secure, controlled MS Excel–based database
- Structured query management, including discrepancy identification and resolution
- Ongoing data cleaning, validation, and consistency checks for critical variables
- Independent data review with 100% verification to ensure accuracy
- Coordination and execution of formal database lock procedures
- Support for generating summary tables, listings, and descriptive/statistical outputs
- Assistance with final reports, manuscripts, and audit-ready documentation
Biostatistics Services
- Development of comprehensive Statistical Analysis Plans (SAPs)
- Preparation, validation, and finalization of analysis-ready datasets
- Execution of descriptive and inferential statistical analyses aligned with study objectives
- Generation of high-quality Tables, Listings, and Figures (TLFs/TLGs)
- Subgroup and exploratory analyses, as appropriate
- Independent verification of statistical outputs to ensure accuracy
- Interpretation of results in close collaboration with the Sponsor
- Preparation of statistical sections for Clinical Study Reports (CSRs)
- Delivery of complete, audit-ready analysis files, programs, and documentation
Why Catalyst?
- End-to-end data lifecycle management
- Strong focus on data integrity and audit readiness
- Independent quality checks and verification
- Regulatory-aligned processes and documentation
- Integrated medical writing and reporting support
