Data Management
At SMOLT Lifesciences, our Data Management services ensure the integrity, accuracy, and security of clinical trial data from collection to analysis. We employ advanced Electronic Data Capture systems, robust validation processes, and industry-compliant statistical methodologies to support regulatory submissions and high-quality research outcomes.
Our EDC management services streamline data collection and processing, ensuring compliance with global regulatory standards. We offer:
- Development of comprehensive data management plans and procedures
- eCRF screen design and structured database specification creation
- Audit trail-enabled database construction and validation
- Data entry guidelines and user training to ensure standardized input
- Site and user management for secure trial data access
- Data validation, edit checks, and computerized/manual review for accuracy
- Query management and data clarification forms for real-time issue resolution
- External data integration, including lab data, e-Diary, IVRS, and EDC consistency checks
- Coding and management of safety and concomitant medication data
- Serious Adverse Event (SAE) information management
- Generation of case examination outputs and data management reports
By leveraging cutting-edge technologies, our EDC solutions enhance efficiency, minimize errors, and maintain data integrity throughout the clinical trial lifecycle.
Our statistical expertise ensures rigorous data analysis, enabling meaningful clinical insights and regulatory success. Our services include:
- Study design and protocol development, optimizing research methodologies
- Sample size estimation to ensure robust statistical power
- Comprehensive statistical analysis plans tailored to trial objectives
- DSMB and interim analyses, including participation in Data Safety Monitoring Boards
- Adaptive study designs for flexible and efficient trial execution
- CDISC-compliant datasets and documentation to meet regulatory standards
- Cross-functional data reviews for accuracy and consistency
- Development of statistical tables, listings, and figures for clinical study reports
Why Choose SMOLT for Data Management?
- Expert Team: Experienced biostatisticians and data managers ensuring precision and compliance.
- Regulatory Adherence: Compliance with ICH-GCP, FDA, EMA, and CDISC standards.
- Advanced Technology: Secure, scalable, and efficient EDC and data validation systems.
- Quality & Accuracy: Comprehensive quality control, reducing errors and ensuring reliable outcomes.
- Seamless Integration: Efficient data handling across multiple sources, including central labs and e-Diaries.
At SMOLT Lifesciences, we are committed to delivering high-quality data management solutions that drive clinical research success. Partner with us for efficient, accurate, and regulatory-compliant data handling.