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- Data Sciences & Statistical Solutions
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Data Sciences & Statistical Solutions
Empowering Decisions with Precision Data Management and Expert Biostatistics
iGlobal Data Sciences & Statistical Solutions (DSSS) team delivers high-quality data
management and biostatistics services to ensure your clinical trial results are accurate, reliable, and ready for submission. Combining responsive collaboration, industry expertise, and cutting-edge technologies, we provide the foundation for efficient, compliant, and cost-effective trial execution.
Data Management: Precision and Integrity from Collection to Submission
The iGlobal Data Management team collaborates closely with sponsor project teams to design and implement customized, regulatory-compliant solutions for clinical trial data collection, validation, and analysis. With deep therapeutic and regulatory expertise, our approach ensures the highest levels of data quality and integrity throughout the trial lifecycle.
Key Data Management Capabilities:
- Case Report Form (CRF) Design: Custom-built CRFs adhering to CDASH standards to capture trial data efficiently.
- Data Collection & Validation: Double-data entry for paper-based trials, robust validation processes, and automated query generation to maintain accuracy.
- Integration of External Data Sources: Seamlessly align external data with CRF information for consistency.
- Standardized Medical Coding: Use of industry-standard dictionaries to ensure global compliance.
- Clean Database Delivery: Data prepared for submission in adherence to CDISC standards.
- Real-Time Metrics & Reporting: Access to clinical trial progress through advanced, real-time dashboards.
- Platform Flexibility: Expertise in multiple EDC systems, including iGlobal’s proprietary iTrack EDC™, for streamlined, secure data handling.
Biostatistics: Delivering Insights, Driving Results
Our experienced biostatisticians offer comprehensive support from trial design to submission, ensuring data analysis is efficient, reliable, and compliant. With deep expertise in advanced methodologies and programming using industry-standard SAS® software, we deliver timely results that align with your development goals.
Key Biostatistics Capabilities:
- Protocol Development & Study Design: Power calculations, endpoint strategies, and adaptive design consultation to optimize trial outcomes and reduce time to market.
- Comprehensive Statistical Analysis Plans (SAPs): Detailed descriptions of methodologies and program specifications with customized TFL shells.
- Randomization Plans: Accurate and secure randomization to maintain trial integrity.
- Data Analysis & Interpretation: Integrated efficacy and safety analysis for regulatory submissions, supported by expert interpretation and reporting.
- Advanced Modeling & Analytics: PK/PD analyses, adaptive design consultation, and centralized statistical monitoring to enhance trial efficiency.
- Regulatory & Committee Support: Interim analysis, Data Monitoring Committee (DMC) consultation, and manuscript writing for study results.
The iGlobal Advantage in Data Sciences & Statistics
1. Comprehensive Expertise:
Our team of data scientists, biostatisticians, and database programmers delivers solutions tailored to the unique needs of your study, ensuring seamless integration of data management and statistical analysis.
2. Innovative Technology:
Powered by iGlobal’s proprietary tools like iTrack EDC™, our platforms provide real-time data access, automated query resolution, and advanced visualization for informed decision-making.
3. Flexible and Scalable Solutions:
Whether your study involves decentralized trials, adaptive designs, or large-scale multi-region studies, our DSSS team provides scalable solutions that align with your goals and regulatory requirements.
4. Commitment to Quality:
From CRF design to final submission, our team ensures data is clean, compliant, and ready for regulatory review, minimizing delays and maximizing confidence in your results.
Partner with iGlobal Data Sciences & Statistical Solutions
Ensure the integrity of your clinical trial data and accelerate your path to submission with iGlobal’s precision-driven data management and biostatistics services. Let us empower your trial with insights and innovation that drive success.
Contact iGlobal DSSS today to learn how we can support your next clinical program.
