End-to-End Data Management Solutions
LinShutong provides clinical trial data management services compliant with CDISC standards and ICH-GCP guidelines, covering the full lifecycle from study design to database lock. Our data management team has extensive industry experience and is proficient in various EDC systems, ensuring data accuracy, integrity, and compliance.
We adopt industry-leading data management processes and quality control systems to help clients efficiently complete clinical trial data management and accelerate drug development.
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Compliant with CDISC, ICH-GCP, 21 CFR Part 11 and other international standards
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Support for Medidata Rave, Oracle Clinical, Veeva Vault and other mainstream EDC systems
Data Management Services
Data Management
Professional Data Management Services
CRF Design & Optimization
Design scientifically sound Case Report Forms (CRF) based on study protocols and CDISC standards, optimize data collection processes, and improve data quality
Database Build & Testing
Build CDISC-compliant databases in EDC systems, conduct comprehensive UAT testing to ensure system stability and reliability
Data Cleaning & Review
Develop Data Management Plans (DMP), execute manual and system validation, manage data queries, and ensure data accuracy
External Data Integration
Integrate external data from central laboratories, ECG, imaging, etc., perform data standardization and consistency checks
Data Review & Lock
Execute data review checklists, perform medical coding (MedDRA/WHO-Drug), final database lock to ensure data integrity
Data Management Documentation
Prepare comprehensive documentation including Data Management Plan (DMP), Data Validation Plan (DVP), CRF Completion Guidelines
Why Choose Our Data Management Services
With rich project experience and a professional technical team, we provide clients with high-quality, efficient data management services
Learn MoreExperienced Team
Data management team with average 10+ years industry experience, familiar with various therapeutic areas
System Compatible
Proficient in Medidata Rave, Oracle Clinical, Veeva and other mainstream EDC platforms
Standards Compliant
Strictly follow CDISC standards to ensure data meets FDA, NMPA and other regulatory requirements
Efficient Delivery
Mature data management processes, average 20% reduction in project timeline
Standardized Data Management Process
Initiation & Planning
Develop Data Management Plan (DMP), design CRF, determine EDC system configuration, establish project team and timeline
Database Build & Testing
Build EDC database, configure edit checks, execute UAT testing, train site users
Data Cleaning & Review
Execute data validation plan, manage queries, perform medical coding, integrate external data, conduct regular data review
Data Review & Lock
Execute data review checklist, complete medical coding, generate data review report, final database lock
Data Management Services FAQ
Our team is proficient in various mainstream EDC systems, including Medidata Rave, Oracle Clinical, Veeva Vault EDC, ClinCapture, RedCap, and more. Regardless of which system you use, we can provide professional data management services.
Project timeline depends on study scale and complexity. Typically, database build takes 4-8 weeks, data cleaning runs concurrently with study enrollment, and final database lock requires 2-4 weeks. We provide detailed timeline planning before project initiation.
We have established a comprehensive quality management system, including: detailed data management plans, multi-level data validation mechanisms, regular data review meetings, complete audit trails, and 21 CFR Part 11 compliant electronic signatures to ensure data quality and compliance.
Yes, we provide professional medical coding services, including MedDRA and WHO-Drug coding for adverse events and concomitant medications. Our coders are professionally trained to ensure coding accuracy and consistency.