Clinical Data Management Service

CLINZTECH, Clinical Data Management (CDM) team helps clients maximize the data generated from clinical trial to improve efficiency, reduce overall development costs (Both Paper base and EDC system), and reduce the risk for subjects and themselves for studies ranging from small rare disease studies to large global ones.

Combining a global team with experienced clinical data managers and statistical programmers with innovative, proprietary technologies, our team provides high-quality data throughout the life cycle of a clinical study for periodic analysis, reporting and for regulatory submission, approvals.

• Building several customized database as per Client requirements
• Successful transitioning of on-going project from Study Start-Up to Close-Out Phase
• Operating in accordance with both Client’s or CLINZTECH SOPs
• A focus to minimize customer oversight
• Supporting Metadata Repositories (MDR) and Statistical Computing Environments (SCE) transition and development of Data Standards
• CRF design
• Annotation of CRF
• Edit Checks (programme and manual)
• Testing of Edit Checks
• Complete UAT
• End to End Study Phase
• CRF tracking
• Data Entry
• Discrepancy management
• SAE Reconciliation
• Lab Reconciliation
• Third party Reconciliations
• End to End Conduct Phase
• Quality Control (Internal and External)

End to End Database Lock Phase