Citric Clinical Data Quality Ltd.
Services
Comprehensive Data Quality Solutions
Database Design & UAT
We offer comprehensive database design and User Acceptance Testing (UAT) services, covering everything from specification file creation and edit check development to close collaboration with database programmers. We support initial builds as well as mid-study updates, with flexibility for ongoing adjustments throughout the study lifecycle to ensure your database functions exactly as required.
Data Cleaning & Reconciliation
​Once your database is live, we implement efficient, programmed solutions for routine data cleaning and review. Our approach accelerates turnaround times while maintaining high standards of data quality. We also manage reconciliations with external vendor data, serious adverse events (SAEs), and protocol deviations to maintain consistency and accuracy across all sources.
Medical Coding
We provide expert medical coding services using MedDRA and WHODrug dictionaries. Our coding ensures consistent and compliant classification of adverse events, medical history, and concomitant medications, supporting regulatory submission and signal detection processes.
Medical Review Support
We provide support for medical review processes, helping clinical teams identify trends, flag important data points, and ensure the clinical narrative aligns with data outputs. Our input facilitates better-informed decisions and stronger oversight throughout the study.
Reporting & Visualisation
We generate tailored ad hoc reports and data visualisations to support ongoing study insights and communication. From routine progress updates to specific data summaries, we help teams stay informed and aligned with trial milestones.
SOPs, Templates & Documentation
Citric CDQ supports your trial with a strong documentation foundation. We create and maintain detailed SOPs and template libraries, helping you ensure process consistency and audit readiness from study startup to closeout.
Database Lock Deliverables
Our tools and workflows are designed to deliver clean, audit-ready databases on tight timelines. This efficient approach reduces resource burden while meeting sponsor expectations and regulatory standards. We support interim analyses, final database locks, and related deliverables with speed and precision.
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.