Methodology

Every figure on this site, derived in the open.

The chain from published benchmarks to our savings model, step by step, labeling what is evidence and what is our estimate.

$7–20MPhase 2 CRO contract range, median ≈$13M

Drawn from Sertkaya et al. (2016), the peer-reviewed industry-standard cost reference, based on aggregate data from Medidata's proprietary clinical-trial cost databases. Phase 2 per-study costs range roughly $7M to $20M across therapeutic areas.

$2.4Mmedian monitoring line per Phase 2 trial

Site monitoring is one of the top three cost drivers identified by Sertkaya et al. Combining that categorization with updated Tufts CSDD and Applied Clinical Trials benchmarks puts monitoring at 15–22% of contract. Applied to the ≈$13M median: roughly $2.0–2.9M; we quote the midpoint, $2.4M.

~70%of CRA monitoring labor is templated work

Our own decomposition of the monitoring workflow (source data verification, visit-report drafting, query writing, routine oversight), based on CRO contract analysis and interviews with clinical-operations leads. This is a Rigora estimate, not an independent benchmark, and we label it as such.

$0.4–0.7Mmodeled per-trial savings target

The chain multiplied out: $2.4M monitoring line × ~70% templated share ≈ $1.7M addressable labor, × a 25–40% efficiency target ≈ $420–670K per trial. The efficiency figure is a target, not a measurement. We publish per-pilot measured efficiency as pilots complete, and those measurements replace this model.

Device studies

These benchmarks are drug-trial figures; device studies rarely price the same way. But the monitoring labor they describe has the same shape on pivotal and post-market device studies: source data verification, visit reports, queries, oversight. During a device pilot we model your portfolio directly instead of leaning on drug-trial benchmarks.

Sources

Sertkaya A, Wong H-H, Jessup A, Beleche T. Key cost drivers of pharmaceutical clinical trials in the United States. Clinical Trials 13(2), 2016. DOI: 10.1177/1740774515625964

Abbasi et al. Source data verification of 10,101 eCRFs in the I-SPY COVID platform trial. Communications Medicine 5, 444 (2025). DOI: 10.1038/s43856-025-01126-9

ICH E6(R3) Good Clinical Practice — risk-proportionate monitoring for drug trials. ich.org

ISO 14155:2020 Clinical investigation of medical devices — introduces risk-based monitoring (§6.7) for device studies. iso.org

The numbers are estimates and your portfolio will vary. During a pilot, measured numbers replace these ranges.

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