Clinical Trial Design Automation
This application area focuses on automating and accelerating the design and operationalization of clinical trials, from protocol authoring through configuration of eClinical systems. It uses advanced language models and configurable platforms to draft structured, compliant protocols, standardize terminology, and translate study designs into executable digital workflows, case report forms, and data capture configurations. It matters because trial design and setup are major bottlenecks in drug development—slow, expert‑intensive, and prone to rework due to regulatory, operational, and data‑management complexities. By systematizing protocol creation and rapidly configuring eClinical environments to match those protocols, sponsors and CROs can shorten study start‑up timelines, reduce change‑order costs, support more complex and decentralized trial models, and improve compliance and data quality across the trial lifecycle.
The Problem
“From protocol draft to eClinical configuration in days, not months”
Organizations face these key challenges:
Weeks of back-and-forth to resolve inconsistencies across protocol, SoA, CRFs, and data validation rules
Late discovery of feasibility issues (visit burden, sample size assumptions, endpoints) after protocol approval
Standards mapping (CDISC/controlled terminology) is manual and uneven across studies and vendors