Technology Tales

Pinnacle 21 CDISC Terminology for Validation

Here is an archive of CDISC terminology files used for validation purposes, covering three standard types: SDTM, SEND and ADaM. The files span a considerable range of dates, with SDTM and SEND terminology dating back to 2011 and ADaM files available from the same period, all provided in ODM XML format. It is worth noting that these terminologies are only compatible with Community versions 2.1.3 and 2.2.0, and will not function with version 3.0.0 or any later release.

PMDA New Drug Review with Electronic Data

The Pharmaceuticals and Medical Devices Agency outlines initiatives to enhance drug review processes through the use of electronic study data, emphasising the integration of advanced analytical methods and modelling techniques to improve evidence-based decision-making. These efforts aim to streamline regulatory submissions, reduce administrative burdens for sponsors, and support the development of updated guidelines that may increase the success rate of drug development.

The agency provides detailed guidance on electronic data submission, including revised notifications, validation rules and technical standards, with specific attention to the application of different data validation versions depending on submission timelines. Additionally, it highlights the transition away from requiring certain pre-submission forms for electronic data, while retaining their use for consultation purposes, alongside the implementation of specific software tools for data validation.

TIBCO offers a real-time, AI-enabled composable data platform designed to integrate applications, data and devices across diverse environments, including legacy, edge and multi-cloud systems. The platform supports integration, messaging, event processing and process automation, leveraging advanced analytics, vector databases and low-code tools to streamline development and enhance decision-making. It provides features such as AI-driven insights, copilots for application development and accelerators to simplify complex tasks, enabling users to build intelligent solutions with minimal coding. The platform is utilised by organisations across various industries to achieve real-time data synchronisation, improve operational efficiency and drive innovation through secure, scalable technologies. Resources such as video libraries, downloadable materials and a glossary are available to support users in implementing and optimising their solutions.

Navicat

PremiumSoft CyberTech offers a suite of database management and development tools under the Navicat brand, trusted by Fortune 500 companies. Its current product line up includes Navicat 17, which integrates AI capabilities and supports Snowflake for improved data visibility, alongside Navicat On-Prem Server 3.1, which provides secure, AI-enhanced management of MySQL, MariaDB and PostgreSQL databases for teams. Further offerings include Navicat Data Modeller 4 for data modelling, Navicat BI for visual data analysis and decision-making, and Navicat Monitor 3 for database infrastructure oversight, now extended to PostgreSQL. The company also provides free versions of select tools, including Navicat Premium Lite and Navicat Data Modeller Lite, as well as cloud-based collaboration features enabling teams to work together in real time.

List of ISO 639-1 codes

ISO 639-1 is a standardised system for representing language codes, primarily used in digital contexts to identify languages uniquely. It assigns two-letter codes to languages, such as en for English and fr for French, facilitating consistent identification across software, databases and international communication. The standard includes 183 officially assigned codes, with some deprecated due to changes in language classification or usage. While it focuses on individual languages, it does not cover language families or groups, which are addressed in other ISO 639 sets like 639-2 and 639-3. Its simplicity and brevity make it widely adopted, though it occasionally faces criticism for not reflecting linguistic nuances or regional variations. The system is regularly updated to align with evolving language practices and technological needs.