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.

Robert Hogan, Ph.D. is President and CEO. Bob has many years of industry experience including leadership of R&D IT for a top-ten global pharma company. His focus in recent years has been drug safety IT strategy. He is co-author of “Sethi, S. and R. Hogan (2019). Information Technology in Pharmacovigilance: Current State and Future Directions. In Renz, et. al. (Eds). Pharmacovigilance: A Practical Approach (pp. 181-195). St. Louis, MO. Elsevier, Inc.”

 

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 integrate with MTApi (currently uses same library but different interface)
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
  • add user tracking and throttling (if needed)
  • test global cluster
  • automate unit testing
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.