Clinical Trial Protocol - Less Time, More Events

Posted by Aidan Gannon on Nov 23, 2016 6:02:11 PM
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The time and events all listed on a simple table on one laminated page on the noticeboard above the desk, and a pocket-sized version to be carried in the white coat. A clear and a complete guide on what was to be performed at each patient visit. I realize my transformation into my father is complete now as I can’t resist finishing this paragraph with the words ‘ah, those were the days’!

At all of our focus group meetings with site staff to date, one thing that we heard again and again was how studies are growing ever more complex. The total number of procedures per protocol grew by 57% between 2003-20111.

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Clinical Trial Protocol Time and Events tables now often span four or more pages, and of course there are the obligatory multitude of footnotes in miniscule writing at the bottom of each one.

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When you consider that most clinical research coordinators work across numerous studies, it’s no surprise that 46% of investigator deficiencies are due to protocol non-compliance. So a key priority for us at Longboat was to provide site staff with a clear and complete guide outlining their upcoming patient visit, even in the most complex of trials.

And that’s where our Visit Essentials solution comes in. Essentially, each member of the site team can schedule the system to send a notification in advance of their next patient visit - direct to their desktop, laptop, or mobile device via SMS, email, or calendar event. These reminders contain a full walkthrough of how to perform the visit per the clinical trial protocol, with information on each procedure taken from the various supporting documents - the protocol, eCRF completion guidelines, IB, lab manuals, etc. and there are quick links to all these relevant documents should they be required.

Furthermore, thanks to our unique Protocol Amendment dashboard, these walkthroughs will always be in line with the version of the protocol approved for that site.

I like to think of it as a return to the good old days, thanks to the wonders of modern technology!

If you would like to learn more about Longboat, please click the button below to request a demo and we will be in touch with you shortly.

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References:

1: Tufts CSDD Report, Nov 2012