Friday, May 18, 2012  
 
Theradex
Theradex
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Theradex®
CN 5257
Princeton, NJ 08543

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Theradex®
4365 Route 1 South
Princeton, NJ 08540

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Phone 609.799.7580
Fax 609.799.4148
Email: info@theradex.com

Theratox® — Automated Toxicity and Concomitant Medication Coding
Due to the fact that case report forms allow free text descriptions of adverse events (toxicities) encountered during the course of a clinical trial, a standardized coding system is necessary in order to categorize such events for analytical purposes. Theratox® facilitates the coding process by providing a search or browse interface for matching a specific toxicity the appropriate dictionary code. Theratox® is capable of supporting multiple dictionaries. Theratox® can be used to develop "look up" coding lists, but it can also be used to code individual events when ambiguous descriptive terms require different coding based on other factors in the clinical record.

Theratox® allows simple searching of a dictionary for the appropriate code by entering relevant terms and examining a list of resulting matches from the dictionary. Alternatively the user can browse a hierarchical view of the dictionary, either by selecting conceptual branches directly or by expanding the tree in the vicinity of a search result. When coding events in a large batch, Theratox® enables the user to scan through recently coded events to view and assign the appropriate code based on previous search results for similar terms.

Theratox® technologies can be applied to adverse event descriptions using dictionaries such as MedDRA or COSTART, and to concommitant medications fields using Theradex®'s own concomitant medication dictionary, the WHO dictionary or client provided dictionaries. However, Theratox® technology is not limited to toxicity and medication coding, it can be applied to any free entry fields encountered on case report forms that require coding to ensure consistency and continuity.

Theratox® is password protected in order to ensure appropriate restriction of system access. Each coding assignment tracks the user making the assignment, as well as the date and time the assignment was made.