Planning a clinical trial budget for biomarkers?

Here's where your hours are actually going:

πŸ”Ή Sample collection reconciliation β€” 5–10 hours/week
πŸ”Ή Lab manual updates for protocol amendments β€” 6 hours per version
πŸ”Ή Troubleshooting chain-of-custody gaps β€” 3–6 hours per issue
πŸ”Ή CTA negotiations and vendor wrangling β€” endless

Most teams budget for the assay costs. Few budget for the sample wrangling.

But here's the reality: A Phase 2 trial can generate 500+ samples across 20+ sites. Each site interprets "fasting blood draw at Week 4" differently. Half will call asking if 10.5 hours counts as fasting. The other half won't call at all.

This isn't overhead. It's the backbone of interpretable, audit-ready biomarker data.

The programs that succeed? They plan for operational complexity from Day 1. They build sample tracking into their timelines. They anticipate the vendor delays and protocol deviations.

Because pristine preclinical data means nothing if your clinical samples are collected inconsistently.

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Most Phase 1 biomarker plans cost north of $1M.

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Is your team treating QC as a checkboxβ€”or as the foundation of reliable biomarker discovery?