Citeline's Best-in-Class Data and AI Combine with Risklick's End-to-End Digital Protocol Workflow
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 Norstellacompany, 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 Citelineand follow on LinkedInand 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 Risklickand follow on LinkedIn.
Citeline PR contact:
Diffusion PR for Citeline
citeline@diffusionpr.com
(213) 318-4500
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