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A site management CEO and a human factors specialist on what sponsors miss before a diagnostic study ever starts.

Why lateral flow assays that perform at the bench often break down at the manufacturing line, and what to do before it costs you the product.

Commercial leader with deep IVD industry experience joins the leading diagnostics services provider

DCN Dx’s clinical and data management leaders, joined by Veeva, examine what IVD CROs gain when they replace disconnected study systems with a single connected platform.

DCN Dx thanks everyone who joined our recent Regulatory Affairs Professionals Society (RAPS) webcast, The IVDR Transition in 2026: Parallel Regulatory Planning for EU and US Market Entry.

Why waiting on the IVDR revision carries a cost, and what it takes to plan for the EU and US at the same time.

Notes from a CDMO that has watched the same expensive mistake play out, again and again

What changes for IVD developers and manufacturers now that the FDA Quality Management System Regulation is in force, and where the gap work tends to land.

Study design decisions that determine whether your CLIA waiver data will stand up to FDA review.