Insights
Enrollment Operations Insights
For CRO feasibility teams, clinical operations leads, and patient recruitment professionals.
The Manual Chart Review Problem: Why 40% of Trial Delays Start at Feasibility
Enrollment delays are usually diagnosed as site performance failures. The data tells a different story: most delays are already baked in by the time a site activates, the product of feasibility assessments built on estimated rather than matched patient populations.
The Manual Chart Review Problem: Why 40% of Trial Delays Start at Feasibility
Enrollment delays are usually diagnosed as site performance failures. The data tells a different story: most delays are already baked in by the time a site activates, the product of feasibility assessments built on estimated rather than matched patient populations.
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FHIR R4 and Clinical Trial Matching: What CROs Need to Know Before Signing EHR Access Agreements
EHR access agreements for clinical trial use carry requirements that most CRO legal teams have never seen before. FHIR R4, SMART authorization, data use restrictions by purpose — knowing these terms before the negotiation is the difference between a 4-week or a 4-month data access timeline.
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Why Unstructured Inclusion/Exclusion Criteria Are the Hidden Enemy of Enrollment Speed
Protocol I/E criteria are still written as free text in most trial designs. That single decision forces every downstream system — from chart review to screening logs — to re-interpret the same language independently.
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Patient Privacy in EHR-Based Matching: What Your IRB Will Ask and How to Answer
IRB submissions for EHR-based feasibility matching raise questions that most CROs haven't had to answer before. The answers depend on architecture choices, not just consent forms.
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Better Site Selection Through Patient Data: Moving from Historical Enrollment to Prospective Cohort Analysis
Historical enrollment data tells you where patients enrolled before. Prospective cohort analysis tells you where eligible patients exist now, for your current protocol.
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Finding 1-in-10,000: EHR Matching for Ultra-Rare Disease Trials
Rare disease enrollment has always been a math problem. EHR matching changes the denominator — you can now query across a network of 2–3 million structured records before a single chart is pulled.
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For CRO feasibility teams, clinical operations leads, and patient recruitment professionals.
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