Panel: Ensuring Inspection-Ready Data: Closing the Gaps in the Clinical Data Lifecycle

Session details:

• Uncover data integrity risks emerging from clinical electronic source systems
• Identify gaps in traceability & consistency between source data, trial records, & the TMF
• Strengthen ALCOA+ compliance across the data lifecycle by improving oversight of data from source through submission
• Establish cross-functional accountability between TMF, QA, & clinical teams to enhance real-time visibility, quality signals, & inspection confidence