Clinical Trial Enrollment Thinking

Protocol design, site operations, EHR data matching, and the specific mechanics of enrollment failure. What we have learned building Enrollvue from inside clinical research.

Abstract representation of NLP parsing text into structured criteria
Technology

The NLP Gap in Inclusion/Exclusion Criteria Matching

Most rule-extraction pipelines collapse on negated criteria, temporal qualifiers, and compound conditions. Here is how we approach this problem differently.

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Clinical Operations

Site Activation Timeline Reality: Where the Months Go

Sponsors budget 4 months for site activation. Reality is closer to 7. We break down the actual distribution of delays by phase and what teams can control.

Abstract data transfer friction concept
Partnerships

CRO-Sponsor Data Handoff Friction: A Quiet Enrollment Tax

Every time a CRO hands patient lists back to a sponsor for eligibility review, the process slows. We quantify this friction and discuss how to remove it.

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Research

Protocol Complexity and Enrollment Rate Correlation

We analyzed 60-plus trial protocols across therapeutic areas to map how the number of exclusion criteria correlates with actual enrollment pace at the sites we work with.

Sparse dot pattern representing rare patient population
Therapeutic Areas

Rare Disease Enrollment Is a Different Problem

Prevalence of 1 in 10,000 means patient-matching math is fundamentally different from oncology. Distributed EHR querying, patient registries, and social reach all matter differently.

Abstract structured versus unstructured data contrast
Technology

Structured vs Unstructured EHR Data for Patient Matching

Structured fields cover maybe 30 percent of what the protocol actually asks. The rest lives in free-text notes. Here is what that means for matching accuracy.

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Clinical Operations

PI Burden in Pre-Screening: What Sites Actually Do

We interviewed coordinators at 12 investigator sites about their actual pre-screening workflows. The variation is wider than sponsors assume.

Abstract benchmark comparison visualization
Therapeutic Areas

Oncology Trial Enrollment Benchmarks Worth Knowing

Enrollment rates vary by 3x to 5x across oncology trials with comparable protocols. We look at what the high-performing outliers do differently.

Abstract data architecture with local containment concept
Technology

HIPAA-Aligned Patient Matching Architecture

Patient data does not leave the site. Here is the architecture pattern we use to run matching computations while keeping identifiable records local.

Abstract tension between distributed and centralized models
Industry Trends

Decentralized Trials and the Site Model Tension

DCTs promise broader reach. But site-based enrollment infrastructure is still how most Phase 2 and 3 trials run. We discuss the tension and what hybrid looks like.

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Company

Building Enrollvue: What We Learned in Year One

From first clinical partner conversations to a working protocol-matching engine, this is the honest version of what took longer than expected and what clicked faster.

Abstract timeline delay visualization
Industry Trends

Clinical Trial Enrollment: Why 80 Percent of Trials Run Late

Enrollment delay is the single most cited reason trials miss timelines. We walk through the structural causes: protocol design, site selection, and pre-screening gaps.

Abstract logic structure representing layered eligibility criteria
Technology

What Protocol Criteria Matching Actually Requires

Eligibility criteria look like simple logic statements. In practice they are layered with temporal conditions, lab value ranges, prior therapy windows, and natural language ambiguity.