What are Clinical Data Management Services
Clinical trial data management services are the processes, systems and oversight activities that ensure all trial data collected are accurate, reliable and compliant with regulatory standards. Effective data management covers the full lifecycle of clinical trial data, from database design and case report form (CRF) development to data entry, cleaning, validation and final database lock.
EvoClinical’s Data Management Services
At EvoClinical, our data management solutions are designed to help sponsors maximize data quality while minimizing risk and operational complexity. We deliver audit-ready data that supports successful submissions across every phase of development.
Case Report Form (CRF) & eCRF Design
-Designing CRFs and electronic CRFs that align with protocol requirements and capture all essential data.
-Balancing simplicity for site staff with completeness for regulatory compliance.
Database Design & Build
-Developing secure, user-friendly clinical databases tailored to your study’s needs.
-Supporting CDISC/CDASH standards for interoperability and submission readiness.
Data Collection & Validation
-Implementing processes for accurate data entry and validation.
-Using edit checks, logic rules, and query management to ensure clean datasets.
Data Cleaning & Quality Control
-Continuous data review to identify and resolve discrepancies.
-Ongoing reconciliation of adverse events, labs, and other external data sources.
Medical Coding & Terminology Management
-Coding adverse events, concomitant medications, and medical history using MedDRA and WHO Drug standards.
-Ensuring consistent, regulator-ready classification of terms.
Database Lock & Transfer
-Finalizing clean, validated datasets for statistical analysis.
-Providing secure transfers for regulatory submissions or sponsor archives.
Integrations & Statistics
-Seamless collaboration with biostatistics teams for analysis readiness.
-Ensuring datasets are properly structured for SAP-driven analysis.
Why Data Management matters
Without proper planning and execution, sponsors risk delays, inconsistent results or rejection at regulatory review. EvoClinical’s approach to data management emphasizes both data integrity and operational efficiency, ensuring that every dataset can stand up to scientific, ethical and regulatory scrutiny.
Ensures Data Accuracy
Reliable systems and processes reduce errors, inconsistencies, and missing information.
Reduces Trial Delays
Efficient data flow and early issue detection prevent bottlenecks and costly rework.
Meets Regulatory Standards
Data is collected, processed, and stored in compliance with ICH-GCP, FDA, EMA, and/or Health Canada requirements.
Improves Credibility
High-quality data supports robust analyses and strengthens submissions to regulatory agencies.
Clinical Data Management Services
Why Clients Choose EvoClinical
Your trial data is only as valuable as its accuracy and integrity. EvoClinical ensures your datasets are high-quality, compliant and analysis-ready, giving regulators, partners, and patients confidence in your results.
Contact EvoClinical today to discuss your data management needs.
Regulatory Confidence
Audit-ready data aligned with global standards.
Technology Flexibility
Proficiency across leading EDC platforms and integration tools.
Experienced Team
Senior data managers with cross-therapeutic expertise.
End-to-End Support
From study start-up through database lock and submission.