StudyClose-Out
Meticulous closure of your clinical trials, including comprehensive documentation, data validation, and final reporting. We manage study close-out as a critical operational phase, ensuring full regulatory compliance, data integrity, and readiness for post-study activities.
Our close-out activities include
Final Data Validation and Reconciliation
Thorough review and resolution of all data discrepancies, guaranteeing the reliability and integrity of final datasets for regulatory submission.
Database Lock
Coordination and execution of database lock procedures, ensuring all clinical data is complete, validated, and locked according to predefined quality criteria and regulatory standards.
Final Reporting and Submission Support
Preparation, coordination, and quality review of final study deliverables, including the Clinical Study Report (CSR) and supporting regulatory documentation.
Essential Document Archiving
Complete collection, verification, and secure archiving of trial documentation in full compliance with GCP and applicable regulatory requirements.
Budget Reconciliation
Comprehensive financial review and final reconciliation of study budgets, ensuring transparency, closure of site payments, and alignment with contractual obligations.
At GALSER, study close-out is handled with the same rigor and dedication as study start-up - delivering a complete, compliant, and publication-ready outcome.
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