Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-05-01-2004

The Uppsala Monitoring Center's WHO Drug Dictionary, Information Mediary's Med-ic Smart Package, and Relsys International Inc.'s Argus J

WHO Drug Dictionary

This reference tool from WHO lets investigators from any country speak the global language of medicine

The Uppsala Monitoring Center's (Uppsala, Sweden) partnership with the UN-founded World Health Organization (WHO) allows the company to release electronic reference tools that trial sites around the world can use.

If a trial is running in several different countries, the drugs involved may have different names. This can be a potential problem for adverse event reporting. The WHO Drug Dictionary can ensure that the data from the trials will speak the same language.

This reference tool goes beyond generic and innovator names. It lists every possible name for each drug, as well as a unique code. Therefore, your CRFs will be more easily understood around the globe. It contains over 45,000 names for almost 10,000 drugs, as well as over 16,000 different drug combinations.

Information is added each quarter on new drugs, new indications and new adverse effects. An available DD History gives an audit trail of each drug's background, and a related Adverse Reaction Terminology product lets you know the proper taxonomy for any SAE in the world. For clients who don't need them all, UMC can do a custom search in the adverse reaction database, similar to Lexis/Nexus.

Med-ic Smart Package

Using embedded microchips, a subject's compliance in taking a pill is remembered by the packaging itself Information Mediary (Ottawa, ON) has done the next best thing to having a PI with a clipboard noting when each subject takes a dose of a study drug or placebo. When a pill is popped out of the foil packet, information is recorded on a hidden microchip.

The smart package works in place of other methods for recording when a subject takes a pill, ranging from stan-dard pen-and-paper forms to electronic methods using the telephone, a PDA, the Internet or a combination of methods.

The Med-ic Smart Package contains a chip with sensors attached to each pill's container. They receive a timestamped message when the foil wrapper is punctured. The chip can also record humidity, heat, vibration and radiation, so the site will know if a subject stores medication on a radiator as well as if he or she is consistent in dosage compliance.

Med-ic Smart Packaging uses a popular new technology called remote frequency identification. The microchip in the empty pack transmits the timestamp when the subjects returns to the site. The chip is "read" by an RFID scanner similar to a supermarket barcode laser.

Argus J

The same pharmacovigilant system that worked in Rockville and Brussels can work in Tokyo as well Relsys International Inc. (Irvine, CA) offers a suite of Argus Safety pharmacovigilance software products to help make your eventual FDA and/or EMEA application trouble-free. One of the tools that sets the company apart is Argus J, which gives users the ability to send the same data that was generated for the United States and the European Union to the Ministry of Health, Labor and Welfare, Japan's regulatory authorities.

English is the primary user interface for both Argus J and Argus Safety, but shadow and local fields in Japanese let the same fields double for MHLW authorities. Relsys was able to keep one database featuring both languages, instead of making a whole second database for a Kanji-character display. (Two databases mean twice the possible conflicts and errors.)

Argus Safety offers options besides a database readable in Japan. Other features include an adverse event reporting system that supports Good Pharmacovigilance Practices, Oracle compatibility, and compliance with over a dozen different types of reports.

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