Comprehensive plans defining all data-handling, validation, and quality-control activities to ensure consistency and compliance.

A well-designed Data Management Plan forms the blueprint for every study’s data lifecycle.

At CORONIS, we develop and implement detailed DMPs that define the processes for data collection, validation, query handling, and database lock.

Each plan ensures full transparency, regulatory alignment, and adherence to Good Clinical Data Management Practices (GCDMP) — providing clear guidance for all stakeholders involved in the study.

Custom database solutions designed and validated to guarantee data integrity, traceability, and smooth database lock and transfer.

Our data management specialists design, build, and validate databases tailored to the specific requirements of each study.

Using secure, industry-standard platforms, we ensure flexibility, full audit trails, and regulatory compliance throughout the process.

Key activities include:

• Database design, build, and validation based on study-specific needs
• Quality control and audit trail documentation
• Database lock and data transfer procedures ensuring integrity and traceability

Every database is configured to balance usability with compliance, ensuring accurate, efficient, and transparent data handling from first entry to final lock.

Systematic review and discrepancy management processes that maintain accuracy, resolve queries, and deliver clean, audit-ready datasets.

Data accuracy drives credible results. CORONIS applies a structured validation and cleaning process that detects and resolves issues early, minimizing risk and delays.

Our team performs programmed edit checks, manages discrepancies, and tracks query resolution to maintain continuous quality.

Key activities include:

• Data validation and cleaning through programmed edit checks
• Discrepancy management and query resolution tracking
• Continuous data quality monitoring and documentation for audit readiness

This ensures every dataset is consistent, complete, and ready for statistical analysis or regulatory submission.

Standardized medical coding and AE/SAE reconciliation ensuring consistent terminology and alignment between clinical and safety data.

CORONIS ensures alignment between clinical and safety data through meticulous medical coding and safety reconciliation procedures.

Using internationally recognized medical dictionaries such as MedDRA and ICD-10, our experts standardize terminology and maintain consistency across all datasets.

Key activities include:

• Medical coding and safety data reconciliation using global standards
• Verification of AE/SAE consistency and completeness
• Cross-functional quality review of safety and clinical datasets

The result is clean, harmonized data that meet global submission standards and ensure regulatory compliance.

With CORONIS, data management is more than an operational task — it’s a strategic process that turns information into meaningful, submission-ready evidence.