ISO Standards for Clinical Operations
ISO/NP 25979 aims at “harmonizing clinical trial operations at clinical site and study sponsor sides, optimizing and ethically utilizing resources by standardizing data entities and data transformations for humans and machines, thereby reducing current inefficiencies due to currentsuboptimal data integration and usage.“
Establishing globally recognized data standards for clinical trial execution, providing standardized data models, process definitions and corresponding data transformation and interoperability standards shall enables clinical trial stakeholders to reduce operational costs by optimizing data-related procedures at sponsor and hospital side.
The standard builds on initial Pistoia Alliance initiative, proven ISO foundations (ISO 13972, ISO 13119, ISO/HL7 27932) and aligns with HL7, WHO, FDA, and EMA requirements.
Prioritized Use Cases
Clinical Site Feasibility & Selection: Standardization of site qualification criteria, automated information collection and capability assessments and reporting
Patient Recruitment & Retention: Unified eligibility criteria and recruitment tracking
Bio-sample Management: Standardization of collection, handling, and protocols to deliver complete sample traceability and enhanced data integrity
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Who will benefit from it?
Clinical trials
- sponsors (pharma & biotechs)
- contributors (hospitals, central labs, CRO, academic centers)
- subjects and their family