SAN FRANCISCO, March 11, 2026 /PRNewswire/ -- ClinCapture President and CEO Scott Weidley today announced a major expansion of artificial intelligence capabilities within the company's Captivate® platform, embedding AI directly into the structural foundation of clinical trial design.

As artificial intelligence adoption accelerates across life sciences, ClinCapture is positioning AI at the earliest and most consequential stage of clinical research: study build.

Unlike standalone AI agents layered on top of existing electronic data capture systems, Captivate integrates AI directly into the architecture of trial configuration. The platform now enables sponsors and CROs to automatically generate and configure substantial portions of a clinical trial from structured protocol specifications.

By translating protocol requirements into validated digital components inside its electronic data capture environment, Captivate reduces manual configuration time, minimizes human error, and accelerates time to study launch.

"AI should not sit on top of the workflow. It should strengthen the foundation," said Weidley. "If we make the trial intelligent at the moment it's architected, everything downstream becomes more predictable."

Transforming Clinical Trials from Documents to Digital Models

Clinical trials have historically relied on static protocol documents that must be manually interpreted and translated into electronic systems. This document-driven approach introduces inefficiencies, inconsistencies, and operational risk.

Weidley has long advocated for converting trials into computable digital models rather than static documents.

"Today, protocols are written as text and manually configured inside clinical trial software," he said. "The future is a structured digital construct that can be analyzed, validated, and refined before it impacts real patients."

The newly introduced AI-powered study build engine marks the first phase of ClinCapture's broader intelligent trial roadmap. By automating protocol translation, Captivate establishes a foundation for future AI-enabled simulation, validation, and predictive workflow analysis.

Augmented Intelligence for Regulated Environments

While many AI initiatives in healthcare emphasize automation and workforce replacement, ClinCapture's approach centers on augmentation within regulated environments.

"Clinical research demands oversight, accountability, and compliance," Weidley said. "Our objective is regulated intelligence. AI that amplifies domain expertise without compromising validation, auditability, or quality."

All AI capabilities operate within Captivate's validated infrastructure and ISO-certified quality systems, ensuring alignment with regulatory expectations across global clinical research markets.

Redefining AI in Clinical Research

Industry interest in AI in clinical trials continues to grow, yet much of the innovation remains fragmented across analytics tools, site technologies, and post hoc data analysis platforms.

ClinCapture's strategy embeds artificial intelligence at the structural layer of electronic data capture and study configuration itself, redefining how clinical trial software supports modern research operations.

"This is not about adding AI to EDC," Weidley said. "It is about rethinking how trials are designed and building them smarter from the start."

What Is AI-Powered Study Build?

AI-powered study build refers to the use of artificial intelligence within clinical trial software to automatically translate protocol specifications into structured, validated digital study components inside an electronic data capture system.

Why AI in Clinical Trials Matters

AI in clinical trials has the potential to reduce startup timelines, decrease protocol deviations, improve data consistency, and enhance operational predictability. By embedding intelligence directly into study architecture, clinical research organizations can address inefficiencies before enrollment begins.

About ClinCapture

ClinCapture develops modern clinical trial software solutions for pharmaceutical, biotechnology, medical device, and diagnostics research organizations worldwide. Its Captivate platform supports electronic data capture and advanced study workflows across all phases and therapeutic areas. ClinCapture is 21 CFR Part 11 and GDPR compliant as well as ISO 27001 and 9001 certified and is trusted by leading life sciences organizations globally.

For more information, visit www.captivate.org.

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SOURCE ClinCapture, Inc.