Comprehensive Clinical Data Management Services
Our Clinical Data Management services ensure the highest quality data collection, cleaning, and validation for your clinical trials. We provide end-to-end solutions that comply with regulatory standards and accelerate your path to successful submissions.
From CRF design to database lock, we manage every aspect of clinical data with precision and expertise, ensuring data integrity and regulatory compliance.
Our experienced team utilizes advanced EDC systems, implements robust validation checks, and follows CDISC standards to deliver clean, submission-ready datasets. We work closely with your team to understand study requirements and provide customized solutions that meet your specific needs while maintaining the highest standards of data quality and patient safety.
Frequently Asked Questions
Q: What EDC systems do you support?
A: We support all major EDC platforms including Oracle Clinical, Medidata Rave, Veeva Vault EDC, and our own eAnalytics EDC Pro. Our team is certified in multiple systems and can work with your preferred platform or help you select the best solution for your trial needs.
Q: How do you ensure data quality and integrity?
A: We implement comprehensive data validation plans, automated edit checks, manual review processes, and regular quality control audits. Our processes include source data verification, query management, and reconciliation procedures to ensure data accuracy and compliance with regulatory requirements.
Q: Do you provide CDISC-compliant datasets?
A: Yes, we specialize in CDISC standards including SDTM, ADaM, and define.xml. Our team includes CDISC experts who ensure your data is properly mapped and validated according to the latest CDISC standards for regulatory submissions to FDA, EMA, and other global health authorities.
Our Data Management Services Include
- CRF/eCRF design and development
- Database build and validation
- Data entry and management
- Quality control and cleaning
- Medical coding (MedDRA, WHO-DD)
- SAE reconciliation
- Database lock and archiving
- CDISC mapping and conversion
