Post by Allyfe

Most sponsors focus inspection readiness on their pivotal trial. Makes sense — that's the data driving approval. But here's what catches them off guard: EMA doesn't just inspect your pivotal trial. They can request access to any trial supporting your submission — Phase 1, Phase 2a, that extension study you closed two years ago. And they sometimes choose the one you've forgotten about. When they do, they'll ask: → Can you reconstruct this trial from the TMF? → Where's the audit trail? → Why were 400 documents uploaded the week before this inspection? Common problems with closed/archived TMFs: 🌐 eTMF contract lapsed, no proper export 🌐 Audit trail missing or incomplete 🌐 Documents scattered across SharePoint, email, and "that folder on someone's laptop" If your early trials aren't inspection-ready, your submission isn't either. Before you scale to your next phase, ask yourself: could an inspector reconstruct our Phase 1 today? If the answer is "I don't know" — that's the problem. If you're preparing for a submission and not sure about the state of your earlier trials, we are happy to talk through what inspection-ready actually looks like across your full program. Schedule a demo here: www.allyfe.health #ClinicalTrials #eTMF hashtag #InspectionReadiness #RegulatoryAffairs #Pharma hashtag #Biotech