Sep 29, 2017
Data standards are the rules by which data are collected, described, categorised and presented in a common format. Data is extracted into our Data Platform from multiple heterogeneous sources and must be transformed into standard formats for analysis, exchange and archiving.
Data is extracted into our ConneXon Data Platform from multiple varied sources and must be transformed into standard formats for analysis, exchange and archiving.
SNOMED CT (Systematised Nomenclature of Medicine Clinical Terms) is a standard vocabulary of clinical terminology used for electronic exchange of health data. NorthWest EHealth map all coded data to SNOMED CT codes for improved data analytics and exchange.
CDISC (Clinical Data Interchange Standards Consortium) Operational Data Model (ODM) is a vendor-neutral, platform-independent format for exchanging, auditing and archiving clinical study data.
Data collected by NorthWest EHealth during clinical trials using its configurable Electronic Case Report Form application conforms to ODM standard (v1.3.2) CDISC Study Data Tabulation Model (SDTM) is a standard for organising and formatting data for analysis and reporting. It is one of the required standards specified in the FDA’s Data Standards Catalogue (section II.C) for new drug applications (NDAs). We transform coded and collected data into SDTM standard domains for electronic regulatory submissions.
In-built technical and operational safeguards;
Our Quality and Information Security Management System is certified against the ISO 9001 and 27001 standards. We are fully committed to ensuring data confidentiality, integrity and availability and our Master Data Management System incorporates the best of both national and international standards for data collection and presentation.
John McCrae - Chief Technology Officer - NorthWest EHealth
Speak to us to find out about our data standards and how we work with data.