Enrollment challenges differ by trial type. Enrollvue handles the range.
From oncology to rare disease, multi-site Phase 2 to decentralized trials.
Oncology
Oncology protocols carry the highest I/E criterion density of any therapeutic area. Biomarker gates, prior therapy lines, washout windows, and RECIST requirements can stack to 20-plus criteria per protocol. Manual chart review against this complexity is where sites lose weeks before the first patient is contacted.
A coordinator at an academic medical center running a Phase 2 HER2-positive breast cancer trial described their pre-screening as "reading five pages of charts per patient to confirm three criteria." Enrollvue restructured that as an automated query against their Epic records, returning a ranked list in hours rather than the three weeks that preceded it.
- Biomarker-specific inclusion criteria (HER2, KRAS, EGFR, PD-L1) matched against pathology and molecular reports
- Washout period calculations across prior therapy lines, including exception handling (adjuvant trastuzumab carve-outs)
- RECIST 1.1 measurable disease and ECOG performance status evaluated against imaging notes and clinic visit summaries
- Evidence snippets retained per criterion for regulatory audit trail at each site
Rare Disease
When prevalence is 1 in 10,000, the enrollment problem is not speed, it is completeness. Missing a candidate who qualifies is not recoverable the way it is in an oncology trial with a large patient population. Enrollvue's role in rare disease is to make sure no eligible chart goes unreviewed, running the full site population against the criteria rather than relying on coordinator recall of which patients might qualify.
For a clinical operations director at a mid-size CRO managing a lysosomal storage disorder study across seven sites, the problem was inconsistency: some sites screened aggressively, some screened almost nothing. Enrollvue gave every site the same systematic query, surfacing candidates that would not have appeared through standard coordinator review.
- Multi-site candidate aggregation for low-prevalence conditions, with site-by-site comparison of screening depth
- Rare diagnosis codes cross-referenced with clinical note language where ICD coding is inconsistent or delayed
- Genetic marker criteria parsed from molecular pathology reports, including variant nomenclature
- Candidate flagging for sites managing concurrent trials with overlapping patient populations
Cardiovascular and Metabolic
Cardiovascular and metabolic protocols often target patient populations that are densely comorbid. A patient with type 2 diabetes, stage 3 CKD, and prior MI can fail multiple exclusion criteria independently. The coordinator's job is to correctly evaluate all of them together, and the chance of error increases with each additional criterion in the stack.
Enrollvue evaluates stacked exclusion logic as a unit, not criterion by criterion. A patient who fails any single exclusion is flagged at the top of the output with the specific disqualifying criterion identified, rather than appearing in the review queue for the coordinator to catch manually.
- Stacked exclusion criteria evaluated in combination: all conditions must clear before a candidate appears in the eligible tier
- Lab value thresholds (eGFR, HbA1c, NT-proBNP, creatinine) matched against dated results, with recency checks
- Medication history check for anticoagulation therapy, contraindicated drug classes, and dose-window requirements
- Cardiac history parsed from ECG reports, echo notes, and discharge summaries