2,000 patients. 12 sites. 18 months. One interim safety report filed without knowledge of 47 adverse events that had already happened. Replay the audit trail — see the gap between reality and the record.
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| # | Site | Late Reports | Finding |
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Every trial event, every submission, every site report — bitemporally versioned. Reconstruct what your team submitted and when. Find the gap that matters to the regulator before they do.