Protocol SmartDesign

Developing a clinical trial protocol can take weeks. Protocol SmartDesign accelerates the process by instantly generating primary endpoints and inclusion/exclusion criteria, to maximize success and minimize amendments.

Powered by industry leading Trialtrove data

340,000+

Trials

45,000+

Data Sources

250+

Diseases

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How it helps

With best-fit primary endpoints and I/E criteria, you not only streamline clinical planning but build studies with more predictable timelines. Protocol SmartDesign provides a centralized platform that facilitates effective communication; teams can review, refine, and finalize the protocol, all in one place.

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How it works

Our advanced AI models mine 60,000 data sources — starting with our gold-standard Sitetrove and Trialtrove data — to generate endpoint and I/E recommendations specific to your trial. This computerized process is supplemented with human oversight: 50 analysts with specialized focus areas, including clinical expertise, aggregate and curate the data to ensure the accuracy of recommendations.

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Why it matters

According to a study by the Tufts Center for the Study of Drug Development (Tufts CSDD), 57% of protocols had at least one substantial amendment, nearly half of these which were deemed avoidable. The study also found that the cost to implement a substantial amendment was $141,000 for a Phase II protocol and $535,000 for a Phase III protocol.

Take an interactive tour of the platform

For the best experience, please take the interactive demo on a laptop or desktop device.



What’s included
Details, details

View source information on which each recommendation is based

One and done

Share protocols with key stakeholders in a single platform

Crystal ball

See forecasted trial duration, based on historical and performance data

Flip a switch

Edit recommended I/E criteria, and forecasted enrollment rate and trial duration will update

Explore Protocol SmartDesign further

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OCT 11, 2024
Product Information
Clinical

Citeline SmartSolutions

Learn more about the smart approach to protocol optimization and study start-up. Download the flyer today.

AI
OCT 11, 2024
Whitepaper
Clinical

AI in Pharma: Benefits, Risks, and the Road Ahead

AI is being used to streamline and accelerate each step of the drug development process from research through approval and marketing.

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NOV 04, 2024
Use Case
Clinical

Optimizing a Breast Cancer Clinical Trial with Data-Driven Solutions

A global pharmaceutical company leverages Citeline solutions to provide instant recommendations on key trial parameters — harnessing the gold-standard clinical trial data of Trialtrove and Sitetrove.

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