Real-time patient feasibility for every trial planning decision

Cohort SmartBuilder tests inclusion and exclusion criteria against real-world patient data, so sponsors can design more recruitable studies before the protocol is finalized.

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Why it matters

Design protocols around real patients

Most protocols rely on historical averages and manual checks. Cohort SmartBuilder tests eligibility criteria against real-world patient data to improve feasibility from the start.
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Real-time protocol feasibility

Every inclusion and exclusion criteria updates your recruitable cohort.

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Built on real-world patient data

Counts come from curated open claims, lab, and EMR data.

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Built for clinical teams

Eligibility criteria map automatically, without code or analyst resources.

Features

What you can do with Cohort SmartBuilder

Validate protocol feasibility

Test inclusion and exclusion criteria against real-world patient data and see how changes affect patient availability.

  • See the impact of eligibility criteria in real time
  • Validate feasibility against actual patient populations
  • Balance protocol requirements with recruitment potential
Dashboard featuring Patient Cohort data with Inclusion and Exclusion Criteria filtering options.

Strengthen study design

See which eligibility criteria have the greatest impact on recruitment and refine your study design before costly amendments are needed.

  • See what is limiting patient availability
  • Compare different cohort scenarios
  • Reduce the risk of costly protocol amendments
Dashboard featuring results of Patient Cohort filtered specifically for Type 2 Diabetes.

Find the right patients faster

See where patients are located and which regions offer the greatest eligible population.

  • Map patient demographics and geography
  • Identify regions with the largest relevant patient populations
  • Surface recruitment risks before study start
Product dashboard showing Patient Cohort results broken down by age, rate, and United States distribution.
The data

The industry’s most robust real-world dataset

Cohort sizing draws on open claims, lab, and EMR data delivered through NorstellaLinQ, Citeline’s real-world data foundation, and on ICD-10 mapping validated by Citeline’s in-house clinical experts.
300M+
open-claims US lives
265M+

lab US lives

50M+

EMR US lives

80K+
ICD-10 codes mapped
Why Citeline

Feasibility you can stand behind

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Curated real-world data

Open claims, lab, and EMR data through NorstellaLinQ, clinically reviewed.

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Expert-validated mapping

80,000+ ICD-10 codes validated and mapped by Citeline's in-house clinical experts.

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Real-time and self-service

Counts update as you build, with no coding and no analyst queue.

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Connected to protocol design

Bidirectional flow with Protocol SmartDesign.

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One planning workflow

Aligned across the SmartSolutions clinical planning journey, with direct access to Trialtrove and Sitetrove.

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Global trial footprint

Identify where trials are running, compare geographic strategies, and spot the most active regions by disease.

Use Cases

Where teams put Cohort SmartBuilder to work​

Test inclusion and exclusion criteria against real-world patient data. Build protocol-specific cohorts, evaluate patient availability, and identify feasibility risks while changes can still be made.

See how each inclusion and exclusion criterion affects the eligible patient population. Identify overly restrictive requirements and refine criteria to improve enrollment potential.

Bring eligibility criteria from Protocol SmartDesign into Cohort SmartBuilder, validate them against real-world patient data and generate protocol-ready language supported by evidence.
Cohort SmartBuilder dashboard example featuring inclusion and exclusion criterias.
Dashboard preview of the various filters available for editing criterias.
Cohort SmartBuilder preview screen showing final results of the inclusion and exclusion criterias.
The Stakes

The cost of getting patient feasibility wrong

When eligibility criteria are based on historical averages rather than current patient data, the consequences mean amendments, delays and missed enrollment.
76%
of protocols are amended, most often to change eligibility criteria
260 days

median to implement an amendment, from need-to-amend to approval

$535K
median direct cost per Phase III amendment
~80%
of trials fail to meet enrollment timelines
Sources: Tufts CSDD protocol amendment benchmarks and day-of-delay analysis; peer-reviewed recruitment research.
Compare

Cohort SmartBuilder vs. conventional feasibility

Capability Conventional Feasibility Cohort SmartBuilder
Historical trial benchmarks
Enrollment performance of comparable studies
Real-world data applied directly to eligibility criteria
Recruitable patient counts in real time
Per-criterion impact on cohort size
Self-service cohort building with no coding
Generate protocol-ready eligibility language
Connected to protocol design workflows
Demo

See Cohort SmartBuilder in action

The Suite

Part of Citeline SmartSolutions

Cohort SmartBuilder works on its own, and connects into one planning workflow.

Protocol SmartDesign

Generate evidence-based protocol recommendations for study design.
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Cohort SmartBuilder

Turn validated protocol criteria into a real-world patient cohort.
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Investigator SmartSelect

Turn your patient cohort into a ranked shortlist of sites and investigators.

Pricing

Find the right SmartSolutions plan for your team

Talk to a Citeline expert about your study planning workflow and how Cohort SmartBuilder can support it.

Frequently Asked Questions

Clinical, feasibility, and study-planning teams at pharmaceutical sponsors and the CROs that support them, including medical directors, clinical scientists, and feasibility leads who need to size a recruitable cohort before the protocol is finalized.
Cohort SmartBuilder tests inclusion and exclusion criteria against real-world patient data while protocols are still being designed. Teams can identify restrictive requirements earlier, evaluate enrollment opportunity and make protocol decisions using patient evidence rather than assumptions.
Real-world data delivered through NorstellaLinQ, spanning open claims (300M+ US lives, refreshed weekly), lab (265M+ US lives, refreshed weekly, across 1,100+ hospitals), and EMR (50M+ US lives and 3B+ clinical notes from 50+ health systems and 600+ hospitals).
No. Eligibility criteria map to clinical codes automatically, with no manual lookups, so clinical and feasibility teams build cohorts without writing code or waiting on an analyst.
Yes. Each inclusion and exclusion criterion shows its own impact, and your recruitable cohort updates as requirements change, so you can see which variables restrict enrollment potential most.
Yes. Generate inclusion and exclusion criteria text directly from the codes in your cohort and carry it into protocol design. You can also export presentation-ready cohorts for governance reviews.
Yes. Cohort SmartBuilder works on its own, and bidirectional flow with Protocol SmartDesign is live today. Interoperability with Investigator SmartSelect is in development, with direct access to Trialtrove and Sitetrove across the suite.

Speak to the Cohort SmartBuilder team

Have a question or need more detail? Tell us what you’re looking for, and our team will be in touch shortly.

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