NEW YORK, Jan. 13, 2026 (GLOBE NEWSWIRE) -- Citeline, a leader in clinical solutions for the life sciences industry, and Risklick, a Swiss-based company specializing in AI-driven solutions for clinical trial protocol development, have partnered to develop a holistic solution that spans protocol design and authoring, operationalization and regulatory disclosure.

Industry studies reveal that protocol amendments have risen substantially since 2015. Given that a single protocol amendment can cost between $140,000 and $500,000, sponsors are under pressure to design near-foolproof protocols.

Together, Risklick and Citeline deliver an integrated, intelligent protocol development experience that combines smart authoring with AI-powered optimization, directly in the workflow.​ The result is optimally designed, patient-centered protocols that reduce risk, accelerate timelines and improve enrollment outcomes.​

With deep expertise in protocol component design​, Citeline leverages its robust data and AI for evidence-based optimization of protocol endpoints and inclusion/exclusion (I/E) criteria​. In addition, its AI models — drawing from successful trials, biomarkers, real-world patient data, and proprietary sponsor data — fine-tune operational forecasting and planning​.

“By embedding our best-in-class data directly into a digitized workflow, we are transforming protocol design from a manual hurdle into a high-speed, AI-driven engine that allows sponsors to move from concept to execution faster than ever before,” says Suzanne Caruso, General Manager, Citeline Strategic Intelligence, Clinical & Regulatory.

Risklick, bringing to the table extensive protocol design and authoring workflow expertise and a purpose-built AI platform, ​has digitized the entire protocol development process. Its ​AI assistant focuses on early clinical trial design and literature analysis, based on a user-defined knowledge base​.

"Our mission is to enable the pharmaceutical industry to design a clinical study in just one day,” says Dr. Poorya Amini, Founder & CEO, Risklick. “This partnership with Citeline is a key step toward making that vision a reality, by bringing together an interoperable solution that spans protocol design, operationalization and regulatory disclosure to create a fully connected digital trial ecosystem."

The two companies are digitally transforming protocol development and enhancing data-driven clinical trial design and operations. Their solution combines insights and workflow to improve protocol quality, empowering sponsors to build more predictable trials.​

About Citeline  
Citeline, a Norstella company, powers a full suite of complementary business intelligence offerings to meet the evolving needs of life science professionals to accelerate the connection of treatments to patients and patients to treatments. These patient-focused solutions and services deliver and analyze data used to drive clinical, commercial, and regulatory-related decisions and create real-world opportunities for growth.

Citeline’s global teams of analysts, journalists, and consultants keep their fingers on the pulse of the pharmaceutical, biomedical and medtech industries, covering all with expert insights: key diseases, clinical trials, drug R&D and approvals, market forecasts, and more. For more information on one of the world’s most trusted health science partners, visit Citeline and follow on LinkedIn and X (Twitter).

About Risklick
Risklick is a Swiss-based company specializing in AI-driven solutions for clinical trial protocol development. The company partners with global pharmaceutical and biotech organizations to accelerate innovation by providing advanced tools for protocol design, data-driven study planning, and operational efficiency. Risklick’s flagship platform, Protocol AI™, empowers clinical teams to streamline processes and bring new therapies to patients faster. For more information, visit Risklick and follow on LinkedIn.

Citeline PR contact: 
Diffusion PR for Citeline
citeline@diffusionpr.com 
(213) 318-4500 

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