The diagnostic partner's proposal looked perfect.

20 pages. Clear deliverables. Professional formatting.

My client—a small biotech running their first Phase 1b trial—signed it without question.

18 months later, I got the call.
"Josie, we have a problem."

They'd run every assay exactly as specified. On time. On budget.

But the QC parameters were too stringent for the use case, resulting in huge gaps of missing data.

They'd tested at the wrong timepoints. Not the critical windows that would show pharmacodynamic response.

And the biomarker panel? It was easy to set up as they had already validated it, but it missed key parts of the drug's MOA.

500K+ spent. Data that lacks impact.

Here's what happened:
👉 The diagnostic partner optimized for what they do well. Not what this drug needed.
👉They designed around their existing test menu. Not around the biology.

Diagnostic providers are exceptional at running assays.
But running assays without strategy is just expensive data generation.

Your diagnostic partner can optimize assay performance.
They can't define your strategy.
That's your job.