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Tourtellotte Consulting primarily designed and developed the client's "tele-randomization" system.
Work began in mid 2000 with releases in 4/2001, 9/2001 and forthcoming release early 2002.
This system directly supports Clinical trials globally by providing an IVR (Phone) and analogous Web interface to anyone working on the client study worldwide.
Through these interfaces, users can screen and randomize patients (receive id numbers), dispense drugs (usually double blind), break blind if needed, perform shipping and receiving functions, receive various reports and a host of other capabilities.
The back end of the system provides administrators with a fully web-based administration tool that allows access to and manipulation of just about every data entity in the system. The system also links to other key client systems like the global trials registry (for identifiers) and Oracle Clinical (for randomizations) as well as pharmacy systems (for drug information).
Aside from providing immediate data to the client about what is happening in the field, this system also contains a resupply algorithm (Tourtellotte designed and built) which automatically does forecasting and just-in-time delivery of drugs to all study sites globally. This component is what saves the most money for the client, estimated at $13M for studies started in 2001, significantly increasing thereafter.
Efficiency in conducting a study and collecting data is a key time saver (and thus money saver) for our client during the drug approval process with the FDA and/ or other regulatory agencies outside the US.
Large portions of this system are done in Perl (admin interface, re supply, assorted loaders and other tools). The main interface for outside users is primarily Java, with XML and REXX (IVR) components. The backend is an Oracle Database.
This system also has a WAP (wireless - works on your cell phone) component currently in the testing phase.
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