Seamless Mid-Study IRT Implementation: Preserving Data Integrity with Retrospective Manual Entry
When a late-stage protocol amendment expanded an oncology study and introduced randomisation, the Sponsor (who had been conducting the study without any IRT) needed to implement IRT mid-study, without disrupting sites or compromising data integrity. Almac Clinical Technologies was brought in to lead the controlled transition to IXRS®. Almac’s IRT reconstructed the complete patient and inventory history through carefully governed manual data entry.
This case study demonstrates how Almac Clinical Technologies successfully delivered a compliant, audit-ready IRT solution that aligned seamlessly with actual site activity and EDC records, while maintaining timelines and ensuring zero disruption to ongoing study operations.
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