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Applied Clinical Trials
Vocel's mDiary, Clinical Systems, Inc.'s ClinBook, and Provisio Inc.'s iTrials
Vocel (San Diego, CA) has come up with an innovative, inclusive solution for electronic clinical trials: combine the benefits of IVRS and PDAs with a flip-style cellular phone.
As with the standard interactive voice-response systems, the mDiary(tm) is connected to a database server, so all responses go directly to the server. (They also go to a secure United States Postal Service server; a USPS "electronic postmark" appears at the end of every session.) As with PDAs, the LCD screen allows for a full-color display with illustrations, text, analog scales, and multiple-choice questions and well as input fields. Questions can be changed mid-study, and each compliant response gives the user another 10 minutes of personal phone time.
Vocel's adverse event log was not able to blend all of its two parents' benefits without adding in a few liabilities. The phones aren't free, and many subjects who already have a cell phone may not enjoy having a second one. The phone is only as good as the network using it, which could be trouble for people in rural and heavily urban areas.
Vocel also offers SAT prep questions, games, and email cell phone services.
Clinical Systems, Inc. (Garden City, NY) offers a sophisticated suite of labeling aids, from text layout to blank stocks clients can fill out themselves. To solve a pernicious problem of global labels, they took a page from page-a-day calendars.
Most large trials will need labels in more than one language, but the expense and time of having separate print runs for each different type of label is frustrating. Also, an unused Spanish-labeled container can't be shipped to a French-speaking trial without a label change.
Enter ClinBook, a multipage label that gets printed in all a trial's languages, like VCR instructions in a minute book that is adhered to a pill package like a sticker. All of the pages in this Rosetta Stone, however, are perforated. By tearing out all but the appropriate trial site's language, one label becomes customized for two dozen or more separate languages. Or, leave them all on, and the bottle speaks to billions in their native tongues.
ClinBooks can include options such as four-color printing, scratch-off unblinding labels, and durable plastic label covers, and come in sizes and die cuts appropriate for any dispenser or bottle. The entire process is cGMP compliant.
Provisio Inc. (Nashville, TN) realizes that for every CRO scouring far and wide for a particular subject, there is a person matching that exact description on file in a doctor's office, ignored. Its iTrials service tries to introduce the potential subject with the questing sponsor.
A big part of any trial is the subject recruitment phase, increasingly focused on media advertising. The iTrials method takes a step in the opposite direction, relying on a web of PPOs, pharmacies, and private-practice physicians to bring potential subjects to 700 private-practice offices containing over 323,000 doctors. Provisio has a relationship with The Independent Physician Association of America which allows the start-up to search participating doctors' files for possible matches with a sponsor's upcoming trial. The end result: millions of patient records viewable to see if any would make for good subject material.
Thanks to a partnership with The Independent Practice Association of America, Provisio has a foot in the door of over a third of all IPAs nationwide.