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Data Management and Analysis

Our Clinical Data Management and Analysis services are designed to ensure the integrity, accuracy, and reliability of clinical trial data. We help organizations manage, analyze, and interpret clinical data to support informed decision-making and regulatory compliance.

Clinical Data Management (CDM)

  • Data Collection: Efficient and accurate collection of clinical trial data using electronic data capture (EDC) systems.​

  • Data Cleaning: Rigorous data cleaning processes to ensure data quality and consistency.​

  • Database Design: Custom database design tailored to the specific needs of each clinical trial.​

  • CRF Design: Development of case report forms (CRFs) to capture relevant data effectively.​

  • Data Entry and Validation: Timely data entry and validation to maintain data accuracy.

Statistical Analysis

  • Study Design Consultation: Expert guidance on study design and statistical methodology.​

  • Statistical Programming: Advanced statistical programming using SAS, R, and other tools.​

  • Data Analysis: Comprehensive data analysis to generate meaningful insights.

  • Statistical Reporting: Preparation of statistical analysis plans (SAPs) and detailed statistical reports.​

  • Interim Analysis: Conduct interim analyses to monitor trial progress and make data-driven decisions.

Data Integration and Standardization

  • Data Integration: Integrate data from multiple sources to create a cohesive dataset.

  • Standardization: Ensure data standardization using CDISC (Clinical Data Interchange Standards Consortium) standards, including SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model).

Regulatory Submission Support

  • Regulatory Documentation: Prepare comprehensive regulatory documents, including clinical study reports (CSRs) and integrated summaries of safety and efficacy (ISS/ISE).

  • Submission Readiness: Ensure data and analysis are ready for submission to regulatory authorities.

Data Visualization

  • Data Visualization Tools: Use advanced data visualization tools to present data in an easily interpretable format.

  • Dashboards: Create interactive dashboards for real-time data monitoring and analysis.

  • Graphical Representation: Develop graphical representations of data to support clinical study findings.

Quality Assurance

  • Quality Checks: Implement rigorous quality checks at every stage of data management and analysis.

  • Audit Readiness: Ensure audit readiness through meticulous documentation and process adherence.

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