Connected clinical trial planning in one AI-powered workflow

Citeline SmartSolutions connects protocol design, real-world patient feasibility, and site and investigator selection in one continuous data-backed workflow.

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Three solutions. One workflow.

Protocol design, cohort feasibility and investigator selection in one connected workflow.

Strategy & Protocol Optimization

Evidence-based endpoint and eligibility recommendations.

Patient Cohort Building

Build validated real-world cohorts from protocol criteria.

Site & Investigator Selection

Find the right matches based on experience and patient access.

Features

What you can do with Citeline SmartSolutions

Protocol design and optimization

Generate evidence-based endpoints and eligibility criteria, then assess the impact on enrollment and study timelines.

Generate recommended endpoints and I/E criteria
Forecast enrollment rate and study duration
Trace recommendations to source trials

Patient cohort feasibility

Test protocol criteria against real-world patient data and see how every eligibility decision changes the available patient population.

Build protocol-specific cohorts in real time
Identify the criteria restricting patient availability
Carry validated criteria back into protocol design

Site and investigator selection

Identify protocol-matched investigators using experience, capacity, patient access and proprietary performance data.

Generate a ranked investigator shortlist
Compare forecasted enrollment by country
Surface qualified investigators beyond existing networks

The numbers that matter

445K+

clinical trials tracked

300M+

US lives across open claims

570K+

investigators worldwide

Smarter decisions across trial planning

How It Works

From protocol draft to investigator selection

Map eligibility criteria to real patients

Inclusion and exclusion criteria from Protocol SmartDesign map to 80,000+ ICD-10 codes in Cohort SmartBuilder automatically. No coding or analyst support required.

Connect protocol design and patient feasibility

Validate criteria against real patients, refine them before the protocol is finalized and carry the validated cohort back into protocol design.

Translate patient feasibility into site and investigator selection

Move from validated cohorts and protocol criteria straight into Investigator SmartSelect to find the countries, sites, and investigators with proven access to those patients.

Citeline is a tremendous partner, enabling us to understand the competitive landscape and key metrics for clinical trials. The insight Citeline provides forms part of our daily workflow, helping us to build consensus and take action accordingly.

Citeline’s data and AI-driven insights helped our team strengthen recommendations across country mix and site selection, helping us identify new recruitment opportunities and support trial success.

The Stakes

Disconnected planning has a real cost

Protocols built without real-world evidence and sites chosen without data don’t just slow teams down. They show up later as amendments, delays, and missed enrollment.

76%

of protocols are amended to revise eligibility criteria

~80%

of trials miss enrollment when site selection isn’t data-backed

~260 days

median time to approve a single protocol amendment

$535K

median direct cost of that single amendment

Sources: Tufts Center for the Study of Drug Development (CSDD) protocol-amendment and day-of-delay analyses; peer-reviewed clinical-trial recruitment research.

COMPARE

SmartSolutions vs. traditional trial planning platforms

Capability	Traditional trial planning platforms	SmartSolutions
Historical trial benchmarking
Investigator search and selection
Protocol design support
AI-generated protocol recommendations
Real-time patient feasibility
Protocol-responsive forecasting
Protocol-matched investigator recommendations

Your data

Securely tailor recommendations with your own data

Organizations can choose to use their own data alongside Citeline intelligence to generate recommendations tailored to their organization, within a secure dedicated environment.

Dedicated secure environment

Use SmartSolutions within a secure environment built specifically for your organization.

Your data and Citeline intelligence

SmartSolutions can combine internal data with Citeline intelligence to create recommendations that reflect your business needs.

Exclusive to your organization

Data remains ring-fenced and is never shared. Recommendations are delivered only within your SmartSolutions workspace.

See it in action

Watch Smarter Clinical Trial Design at Work

See how Citeline SmartSolutions turns protocol planning and patient feasibility into one connected walkthrough, backed by real-world data.

Demo

See smarter trial design in action

Pricing

Find the right SmartSolutions plan for your team

See how AI-powered workflows across protocol design, patient feasibility, and site selection can optimize your trial planning. Talk to the team today.

latest insights

Explore further resources

Article

How AI Has Revolutionized Clinical Development

Customer Story

A Mission to Expand Recruitment Territory

Customer Story

Trial Rescue & Reconnaissance

Frequently Asked Questions

What is Citeline SmartSolutions?

Citeline SmartSolutions connects protocol design, patient feasibility, and site and investigator selection in one AI-powered suite, helping teams plan more successful clinical trials.

Who is SmartSolutions designed for?

SmartSolutions is designed for sponsors, CROs and clinical development teams working across study design, feasibility, patient cohorts, and site and investigator selection.

How does Protocol SmartDesign generate its recommendations?

Protocol SmartDesign uses AI to analyze historically successful trials and recommend endpoints and eligibility criteria, with forecasts for enrollment rate and study duration. Each recommendation links back to the source trials behind it.

Where does the patient data in Cohort SmartBuilder come from?

Cohort SmartBuilder uses US real-world data delivered through NorstellaLinQ, including open claims, lab and electronic medical record data.

How does Investigator SmartSelect rank investigators?

Investigator SmartSelect uses machine learning trained on Citeline’s trial, site, and performance data, including proprietary data from our partnership with Greenphire. It scores investigators across 22 factors such as experience, outcomes, and patient access, and teams can adjust weighting for US and global priorities.

Do the three products work together or can they be used independently?

Each product works as a standalone tool. Protocol SmartDesign and Cohort SmartBuilder already connect, so validated cohorts carry directly back into protocol design. Interoperability with Investigator SmartSelect is in development, with direct access to Trialtrove and Sitetrove available across the suite.

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