In this episode of Expert Insights, Mitzi Rettinger sits down with Sarah Barchard, Senior Clinical Trials Manager at DCN Dx and co-author of our Expert Insights whitepaper on de-risking IVD studies for regulatory success. Sarah shares the most common and costly pitfalls she’s seen in hundreds of diagnostics programs, and walks through practical strategies for getting clinical, regulatory, and data teams aligned early. The conversation spans intended use, pre-submission engagement, biostatistics, human factors, and what it actually looks like to “fix” a struggling clinical trial before it derails a submission.