Planning a clinical trial budget for biomarkers?
Here's where your hours are actually going:
πΉ Sample collection reconciliation β 5β10 hours/week
πΉ Lab manual updates for protocol amendments β 6 hours per version
πΉ Troubleshooting chain-of-custody gaps β 3β6 hours per issue
πΉ 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.