ACCURACY
Robust CRF and database design enables precise, clean, and reliable data collection.
Data Management
Data Management
Our data management services are designed to ensure accurate, consistent, traceable, and high-quality clinical data throughout the study lifecycle.
• Data Management Plan (DMP) development
• CRF / eCRF design and review
• Database build, testing, UAT, and validation
• Interim and annual report listings
• Adverse Event (AE) / Serious Adverse Event (SAE) tracking and reconciliation
• CDISC-compliant data management and reporting, where applicable
• Edit check programming and testing
• Remote data review and continuous quality checks
• Query generation, management, and discrepancy resolution
• Data cleaning, reconciliation, and database lock support
Biostatistical Solutions
Our biostatistics team provides strategic statistical support from study design through final analysis and reporting. We develop fit-for-purpose statistical approaches that align with study objectives, endpoints, regulatory expectations, and scientific requirements
• Study design and statistical methodology
• Endpoint definition and statistical analysis planning
• Sample size and power calculations
• Statistical programming for regulatory submissions
• Data analysis for scientific manuscripts and publications
• Result interpretation and actionable insights
• Effect size estimation
• Randomization schedule generation
• Statistical analysis and interpretation
• Tables, Listings, and Figures (TLFs)
RANDOMIZATION & ALLOCATION
MDL develops robust randomization strategies to minimize allocation bias and support the scientific integrity of clinical studies. Our team can generate study-specific randomization schedules based on the protocol design, allocation ratio, stratification requirements, and other statistical considerations.
SAMPLE SIZE & POWER CALCULATION
We provide scientifically justified sample size and power calculations to support efficient and adequately powered clinical studies. Calculations consider factors such as effect size, variability, significance level, desired power, study design, and allocation ratio.
STATISTICAL PROGRAMMING & REPORTING
MDL provides statistical programming and reporting support for clinical study analysis, regulatory submissions, and scientific publications. Our team develops analysis datasets and generates accurate Tables, Listings, and Figures (TLFs) with appropriate quality checks and regulatory considerations.
Capabilities include:
• Statistical programming
• Analysis dataset preparation
• TLF generation
• Database-to-analysis data review
• Statistical outputs and result interpretation
• CDISC-aligned reporting, where applicable
• Regulatory and manuscript reporting support
Data Cleaning And Monitoring (Adverse Event Monitoring)
MDL provides comprehensive clinical data cleaning, ongoing data review, and safety monitoring to ensure data accuracy, consistency, completeness, and traceability throughout the study lifecycle. Our capabilities include query and discrepancy management, AE/SAE tracking and reconciliation, medical coding, safety data review, and preparation/support for periodic and aggregate safety reports, including PSUR/PBRER and DSUR, SUSAR as applicable.
AE/SAE data capture and review
• Medical coding using MedDRA
• Safety database integration and tracking
• PSUR/PBRER support
• DSUR support
• Safety reporting and regulatory documentation
Continuous quality checks and discrepancy management
• Clinical and safety database reconciliation