Protocols built for real-world performance

Protocol SmartDesign combines AI-powered recommendations, trial performance data, and enrollment forecasting to help teams deliver successful clinical trials.

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Why it matters

Design protocols built to enroll

Protocol SmartDesign gives medical and clinical operations teams a data-backed head start, right from the first draft.
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Recommendations you can trust

Endpoints and I/E criteria informed by historically successful trials.

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Timelines you can stand behind

Enrollment rate and study duration forecast from trials most like yours, not a blanket average.

Decisions backed by evidence

Every recommendation carries its source trials, viewable directly inside Trialtrove for review.

Features

What you can do with Protocol SmartDesign

Get best-fit endpoints and criteria in minutes

Get endpoints and criteria ranked by what has proven successful in past trials, a starting point you refine with your own clinical expertise.

  • Rank primary endpoints by prevalence in past successful trials
  • Sort inclusion and exclusion criteria into expert-built categories
  • Refine recommendations with full visibility into supporting evidence
Dashboard showing a table of results of successful clinical trials that were used by an AI model.

Forecast enrollment and duration before you commit

See the enrollment rate and study duration your criteria produce, before you lock them in.

  • Compare median sites and participants against similar trials
  • Forecast enrollment rate in patients per site per month
  • Track study duration as you edit your criteria

See the evidence behind every recommendation

Every recommendation is backed by transparent evidence that medical and clinical operations teams can review together.

  • Attach source trials to every endpoint and criterion
  • Review unsuccessful trials to see what to avoid
  • Review recommendations, forecasts, and supporting evidence in one shared workspace
The Data

Built on Citeline's curated trial data

Recommendations draw on Trialtrove, built from 58K+ unique sources across 310+ diseases and 9 therapeutic areas, maintained by analysts with specialist focus areas.

445K+
clinical trials
750K+
I/E criteria
1,700+
endpoints
Why Citeline

Evidence you can stand behind

Trusted clinical intelligence

Grounded in Citeline's curated trial, endpoint, and criteria data rather than scattered literature review.

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Clinical-trial-specific AI

A model built for protocol design with subject-matter experts, not a repurposed general-purpose tool.

Traceable to source

Trace any recommendation to the trials behind it, viewable directly in Trialtrove. No black-box output.

You stay in control

AI-generated recommendations are a starting point. You refine every endpoint and criterion with your own clinical expertise.

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Curated by experts

Analysts with specialist focus areas maintain data quality, backed by 20+ years of clinical intelligence.

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Connected planning

Carry protocol criteria into Cohort SmartBuilder and Investigator SmartSelect across the SmartSolutions workflow.

How It Works

From study criteria to a protocol backed by evidence

Recommended primary endpoints and I/E criteria arrive ranked by prevalence in trials that completed on schedule, sorted into expert-built categories, and open to edit with your own clinical expertise.

Median sites, median participants, and forecasted enrollment rate and study duration sit alongside every recommendation, and update automatically as you refine your criteria.

Every recommendation links to its source trials, with sponsor and timeframe, viewable directly in Trialtrove, including trials that were not operationally successful.

Protocol SmartDesign example dashboard featuring a list of successful clinical trials from Citeline's AI model.
Protocol SmartDesign dashboard showing recommended primary and secondary endpoints, with statistics for sites, participants, and enrollment rates.
Dashboard displaying five type 2 diabetes studies with statuses, drugs, patient segments, and sponsors.
The Stakes

The real cost of a weak protocol

Endpoints and criteria set on precedent look reasonable on paper and expensive in the field. The cost turns up later as amendments, delays, and enrollment you never reach.
76%
of protocols require at least one amendment
~260 days
to implement a single amendment
3.3
amendments per protocol, on average
~$500K
lost per day of trial delay
Sources: Getz et al., 2024, Tufts Center for the Study of Drug Development (TIRS 58(3):539–548); Applied Clinical Trials cost-of-delay analysis.
COMPARE

Protocol SmartDesign vs. traditional protocol design

Capabilities Traditional protocol design Protocol SmartDesign
Review protocol approaches from similar trials
Review source trials supporting design decisions
Endpoints and criteria informed by historically successful trials
Enrollment rate forecast for your exact criteria
Study duration forecast that updates as you edit
Recommendations linked directly to supporting trials
Unsuccessful trials shown alongside successful ones
Demo

See Protocol SmartDesign in action

The Suite

Part of Citeline SmartSolutions

Protocol SmartDesign works on its own, and connects into one workflow: from protocol design, to cohort planning, to site and investigator selection.

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 access, setup, and getting started with Protocol SmartDesign.

Frequently Asked Questions

Protocol SmartDesign uses AI and historical clinical trial data to recommend primary endpoints and inclusion/exclusion criteria, while forecasting enrollment rate and study duration.
Protocol SmartDesign is designed for medical and clinical operations teams at pharmaceutical sponsors and CROs involved in protocol design and trial planning.
AI models analyze data from historically successful trials to recommend primary endpoints and inclusion/exclusion criteria and forecast enrollment rate and study duration. 
A trial that completed within 60 days of its anticipated completion date.
Yes. Every recommendation links to the source trials that informed it, viewable directly in Trialtrove. You can also review trials that were not operationally successful.
Yes. Teams can edit and refine recommended endpoints and inclusion/exclusion criteria, with forecasts responding as the criteria change.
Protocol SmartDesign can be used on its own or alongside Cohort SmartBuilder for patient feasibility and Investigator SmartSelect for country, site and investigator selection

Speak to the Protocol SmartDesign 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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