Clinical research company nPhase has launched an end-to-end clinical data management platform designed to help trial sponsors leverage study results with AI.
Called nPhase.ai, the platform also includes the nPhase.ai Statistical Computing Environment (SCE), an AI-native platform built on Clinical Data Interchange Standards Consortium (CDISC) benchmarks, which the company says can transform raw clinical trial data into submission-ready outputs faster and with fewer resources, according to a release.
The platform's SCE component is designed to convert study data into governed and traceable regulatory documents needed for submission, potentially cutting several months of work into weeks.
The platform also aims to speed up submission filing by improving pipeline throughput. At the same time, nPhase expects its tech could also lower costs and allow for small-population research, as well as deploy federated data sharing that ensures all departments and products adhere to legal, scientific and ethical regulations.
Clinical trial data is increasingly voluminous and complex, and a TuftsCSDD analysis found the average phase 3 protocol now generates nearly six million data points. Much of the data is unstructured, making it difficult to analyze with AI. Meanwhile, nPhase aims to connect clinical trial and real-world data to guide clinical decision-making.
“Clinical data has never been more complex, with information flowing from dozens of systems, with different formats, structures, and types,” said Scott Climes, CEO of nPhase, in a release. “nPhase.ai addresses this pervasive challenge by transforming disparate clinical data into high-fidelity, harmonized datasets in near real-time, enabling faster analytics, better insights, and more informed decision-making. Now, with SCE, we are combining the speed and intelligence of AI with human oversight to make clinical data truly AI-ready from source to submission.”
CDISC is a nonprofit that develops, manages and standardizes medical clinical research data in order to speed up medical research and make clinical data more efficient. The FDA requires that trial data complies with CDISC standards.
CDISC standards exist to make clinical data usable across systems and sponsors," said Chris Decker, president and CEO of CDISC in a release. "CDISC’s transformation to machine-readable standards is the foundation that makes automation of clinical data workflows possible. We're glad to see the industry building tools that rely on that foundation.”