Clinical Data Management Support
From CRF design assistance to database lock, we provide comprehensive CDM support ensuring data quality, integrity, and regulatory compliance for your clinical trials.
How We Support You
Database Setup
We assist with CRF design review, EDC configuration, and validation rule development to ensure robust data capture from day one.
Data Operations
Throughout the trial, we support data entry, conduct quality checks, manage queries, and perform medical coding to maintain data quality.
Database Cleaning
We coordinate data cleaning activities, resolve outstanding queries, reconcile discrepancies, and prepare databases for lock.
Lock & Delivery
Upon cleaning completion, we support database lock procedures and CDISC-compliant dataset creation for statistical analysis.
What We Do
We support your organization across the complete data management lifecycle—from CRF design assistance through database lock and SDTM delivery. Our experienced CDM team integrates with your operations to ensure high-quality, clean data that meets regulatory standards.
As your CDM support partner, we bring technical expertise, CDISC knowledge, and meticulous attention to detail that protects data integrity and accelerates database lock timelines.
Our Capabilities
- CRF design review and optimization
- EDC system setup and testing support
- Data validation rule development
- Data entry and quality checks
- Query management and resolution
- Medical coding (MedDRA, WHODrug)
- Database reconciliation and cleaning
- SDTM mapping and dataset creation
What You Receive
Data Management Plans
Comprehensive DMPs outlining data handling procedures, quality checks, and timelines for your trial.
Quality Reports
Regular data quality reports identifying issues, trends, and action items to maintain data integrity.
Query Reports
Detailed query tracking with resolution status, aging metrics, and site-level performance indicators.
Medical Coding
Accurate MedDRA and WHODrug coding with version control and audit trails for regulatory compliance.
Clean Databases
Locked, validated databases ready for statistical analysis with full documentation and traceability.
SDTM Datasets
CDISC-compliant SDTM datasets with define.xml and reviewer's guides for regulatory submissions.