Optimize clinical trial design in one connected workflow.

Validate I/E criteria against real-world populations, benchmark every protocol choice against 60,000+ curated trials, and cut the amendments that slow recruitment before they happen.

Collage of dashboards featuring various charts and plots around clinical trial and patient cohort data.

Built for better protocol optimization and trial design

Trial Design brings together the industry’s most comprehensive clinical trial dataset, advanced analytics, and AI-assisted workflows, helping teams move faster and plan with greater certainty.
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Design protocols that recruit

Build eligibility criteria around real patient populations and recruitment potential.

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Back decisions with evidence

Ground protocol decisions in historical clinical trial insights and real-world data.

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Avoid costly surprises

Flag recruitment and feasibility risks before they cause amendments or costly delays.

The Clinical Intelligence Platform

See how protocol decisions affect feasibility, sites, and recruitment

Trial Design runs on Citeline’s single, unified data layer spanning the full spectrum of clinical development, so every result and recommendation stays consistent and grounded in the industry’s best data.

Citeline workflow diagram Five workflows around a central Citeline Data & APIs hub. CompetitiveIntelligence ProtocolOptimization SiteSelection Patient Strategy& Recruitment Regulatory& Disclosure CitelineData & APIs Patient Intelligence Agentic Workflows

Competitive Intelligence

Understand the competitive picture. Identify where to invest and where to compete.

Protocol Optimization & Trial Design

Design protocols real patients can qualify for, grounded in competitive evidence.

Site Selection

Place trials where eligible patients and capable sites meet.

Patient Strategy & Recruitment

Reach the right patients at the right moment.

Regulatory & Disclosure

Stay compliant and meet critical reporting obligations.

Why it matters

The real cost of designing without real-world patient insight

Without a clear view of patient availability and site feasibility, recruitment problems can surface leading to amendments, missed timelines and underperforming sites.

$170M
Spent by sites on feasibility assessments and qualification visits in 2024
76%
of Phase I–IV protocols undergo at least one amendment
$141K-535K
Median direct cost of a substantial Phase II or III protocol amendment
1 in 3
approved sites under-enroll, while 11% enroll no patients
Source: Tufts Center for the Study of Drug Development research on feasibility, protocol amendments and site performance.
Explore the workflow

What you can do with Trial Design

Design for real patient populations

Test eligibility criteria against real-world patient populations before the protocol is finalized.
  • Validate criteria against patient populations
  • See how amendments affect patient availability
  • Assess feasibility across countries, regions and sites

Strengthen protocol decisions with evidence

Compare endpoints, eligibility criteria, timelines, and enrollment performance across successful trials.

  • Benchmark against 60K+ curated trials
  • Compare endpoints, enrollment, and amendments
  • Generate AI-assisted protocol recommendations

Identify recruitment and feasibility risks

Evaluate enrollment trends, competitive activity, and emerging risks across comparable studies.

  • Compare enrollment performance across similar trials
  • Monitor competing studies and pipeline activity
  • Reduce amendment risk from the start
Visual plot example of Drug Landscape within a product dashboard.
Products & Data

Explore the products behind the workflow

Clinical intelligence, patient data, and AI-powered applications working together in one connected workflow.
Patient intelligence

See the patients behind the protocol

Combine epidemiology, standard of care, and patient journey data to design studies around real-world patient populations and care patterns.
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Eligible patient population

Understand how many patients meet your study requirements.

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Real-world care patterns

See how patients move through diagnosis, treatment, and referral.

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Feasibility insights

Identify risks earlier and make more informed protocol decisions.

Proof

Built on intelligence you can trust

Every recommendation is built on the industry’s most complete clinical intelligence foundation, curated by expert analysts and strengthened with AI.
60K+
Curated trials
190K+
Sites across 185 countries
30+
Years of clinical intelligence
95%+
Validated data accuracy
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Expert-validated, human-led

Analyst-curated intelligence, not raw aggregation. AI supports decisions while your team stays in control.

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Unmatched proprietary data

57%+ more coverage than ClinicalTrials.gov, drawn from sources no public registry captures.

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Clinical intelligence at scale

30+ years of analyst-curated trial, site, and patient intelligence.

How it compares

From siloed analysis to connected decisions

Design protocols around real patient populations, benchmark against what works, and evaluate feasibility earlier, all within one connected workflow.
The Traditional Approach The Trial Design Workflow
Trial, patient, site and competitive intelligence reviewed separately Trial, patient, site and competitive intelligence connected in a single workflow
Eligibility criteria designed first, recruitability validated later Eligibility criteria evaluated against real patient populations during design
Feasibility assessments built through multiple manual analyses Feasibility informed continuously throughout protocol development
Recruitment risks often discovered after launch Recruitment risks identified earlier in planning
Decisions rely heavily on expert judgment and fragmented evidence Decisions supported by patient intelligence, clinical data and AI-assisted recommendations
Pricing

Speak with our team to learn how Trial Design can support your clinical planning process

latest resources

Explore further resources

Healthcare professional on a laptop device with holographic patient charts and data.
Press Release

サイトライン、臨床試験のフィージビリティ評価とプロトコル設計を支援する「Patient Intelligence」を発表

Business professional with their hand out amongst floating, digital graphs and charts.
Customer Story

【日本語版】データで臨床試験は立て直せる―サイトライン×CROの協働で停滞した第III相試験を立て直し、89%の施設妥当性、20%のエンロール改善を実現した事例

Hand with a sterile glove holding a generic pill with holographic charts and visuals.
Article

AIが臨床計画に与えた革命|プロトコル設計、施設選定、フィージビリティ、被験者募集まで

FAQ

Frequently Asked Questions

Trial Design helps sponsors and CROs design more recruitable protocols, benchmark against historical trials, and evaluate feasibility earlier.
Trial Design brings together Trialtrove+, Sitetrove+, Patient Intelligence, APIs, and AI-powered SmartSolutions in a single workflow. Product availability varies by package.
Trial Design uses Patient Intelligence to show how protocol decisions affect real-world patient availability, treatment patterns, and feasibility.
Yes. Cohort SmartBuilder helps teams evaluate how eligibility criteria affect the size and characteristics of the recruitable patient population.

By identifying recruitment and feasibility risks earlier, Trial Design helps teams make better-informed protocol decisions before study launch.

Protocol authoring tools help teams write protocols. Trial Design helps teams evaluate, benchmark, and optimize protocol decisions before they are finalized.
Yes. Trial Design benchmarks endpoints, eligibility criteria, enrollment performance, and timelines against comparable trials using Trialtrove intelligence.
Get started

Speak to the Trial Design team

Tell us where your protocol is today and we’ll show you the fastest path to a design real patients can complete.

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