About Us
MedDRA®
The Medical Dictionary for Regulatory Activities (MedDRA®) is a standardized medical terminology used to facilitate international sharing of regulatory information about medical products. MedDRA® is available for use in the registration, documentation and safety monitoring of medical products both before and after a product has been authorized for sale. Products covered by the scope of MedDRA® include pharmaceuticals, biologics, vaccines and drug-device combination products. This site is intended for use by MedDRA® subscribers. For more information, go to http://meddra.org
MedDRA® is a registered trademark of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Terminologix
Terminologix, LLC is a U.S. consulting company specializing in pharmaceutical R&D IT strategy and software development with a special emphasis on pharmacovigilance.
Mission & Vision
Our mission is to research cutting-edge tools that use MedDRA® and other terminologies to advance the science of drug safety.
Our vision is to establish a community of users who work together to meet real-world pharmacovigilance requirements at the lowest possible cost. State-of-the-art drug safety analysis tools should be accessible to all.
Motivation
MTools began as a research project exploring new ways to mine data from the FDA Adverse Event Reporting Systems (FAERS). Simply aggregating cases by PT codes wasn’t enough. We needed high-speed analysis of tens of thousands of cases against the full MedDRA® and SMQ hierarchies. The MedDRA® Maintenance and Support Services Organization (MSSO) tools weren’t up to the task, so we began exploring what could be done with the latest software technologies.
MTools is the result.
Product Status
MTools web application
Browser | complete |
Research bin | complete |
Coder | complete |
Case series analyzer | working prototype; redesign to upload user meta-data, add features and maintain state across sessions |
Version analyzer | not started |
Technical | fully integrated with MTApi |
Documentation | minimal; more will be added in the form of 2-minute training videos based on user requests along with some formal documentation |
MTApi
Endpoints | complete; supports all features required by web app; will add new endpoints for high-value use cases requested by users |
Technical plans |
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Documentation | minimal; additional training videos, code snippets, tech blogs, and some formal documentation will be added over time, based on user priorities |
This is a research project. The application and API are not validated. Validation testing and documentation under contract only.
Roadmap
Future development priorities will be driven by user feedback and requests. Some of the intended developments are listed under Project Status. This is a volunteer project and there is no published timeline.
Pricing
MTools and MTApi are free to current MedDRA® subscribers. Terminologix retains the right to change this policy at any time, and is likely to do so in order to offset operational costs as use of these tools grows. Our intention is to avoid charges for occasional and low-volume users if possible.
Privacy Notice
The MTools web application and API do not store any personally identifiable information. MTools uses the MSSO identity server to verify your MedDRA® subscriber status, and does not have access to your MedDRA® password. MTools stores your MedDRA® ID for the sole purpose of generating usage statistics and implementing fair access policies. No end-user data or meta-data is retained on the MTools server. MTools web application session information is stored on your local computer and never transmitted to the MTools server. All communication between your computer and the MTools server is encrypted with SSL (https).
Terms & Conditions
Use of the MTools application or API is subject to the terms and conditions of our services agreement at: terminologix.com/tandcs.
Acknowledgments
Many thanks to the MedDRA® Maintenance and Support Services Organization (MSSO) for their advice and assistance. The MSSO has no responsibility for the content or functioning of our products except as set forth in the MedDRA® subscribers agreement.