Citric Clinical Data Quality Ltd.
Data Management Services
Citric CDQ provides expert clinical data management support across the full lifecycle of a clinical study, from database design through to database lock.
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Working directly with a senior clinical data management specialist, sponsors and CRO teams benefit from practical solutions that improve data quality, increase visibility into study progress, and reduce the operational burden associated with manual workflows.
Citric CDQ combines strong CDM expertise with structured automation tools and modern reporting solutions to help study teams manage clinical data more efficiently while maintaining full oversight and regulatory compliance.
Database Design and UAT Support
Citric CDQ supports the design, review, and validation of clinical trial databases to ensure that data collection aligns with protocol requirements and site workflows. Early database involvement helps reduce downstream queries and improves the consistency of site-entered data.
Data Cleaning and Review
Structured data review processes allow teams to identify and resolve issues efficiently. Citric CDQ supports ongoing data cleaning activities using programmatic review tools and structured workflows that accelerate review cycles while maintaining strong oversight.
Vendor Data Reconciliation
External data sources such as laboratories, imaging vendors, and safety systems require careful reconciliation with the clinical database. Citric CDQ implements structured reconciliation processes that help identify discrepancies quickly and maintain data consistency across systems.
Metrics, Dashboards, and Reporting
Clear visibility into study data is essential for effective oversight. Citric CDQ develops metrics frameworks and dashboards that allow sponsors and study teams to monitor query status, reconciliation progress, and data quality trends throughout the study.
Medical Coding Support
Citric CDQ provides medical coding services using recognised industry dictionaries such as MedDRA and WHO Drug. Coding activities are performed with strong quality control and clear documentation to support accurate downstream analysis.
Database Lock Preparation
Preparing for database lock requires coordination across data cleaning, reconciliation, and issue resolution activities. Citric CDQ supports lock readiness by ensuring that review processes are structured, outstanding issues are clearly tracked, and final datasets are prepared efficiently.
SOPs, Documentation, and Process Improvement
Clear documentation and structured processes are essential for maintaining consistent and reliable clinical data management workflows. Citric CDQ supports the development and refinement of SOPs, working instructions, and study documentation to help teams operate efficiently while maintaining strong quality standards.
CDISC & SDTM Standards
We are experienced in applying CDISC and SDTM standards to ensure data is formatted consistently and ready for regulatory submission. We support the creation, review, and delivery of clean SDTM datasets as part of your study’s overall data strategy.
TMF Quality & Regulatory Alignment
We conduct thorough TMF quality reviews and assist with compliance across all trial stages. Our familiarity with TMF structure, requirements, and regular upload processes ensures your documentation remains inspection-ready.