Summary Rollup Reports…

Case Studies

Problem:

Your drug supply depots are using up study drug faster than expected. You need to track down the problem. For one thing, you want to take a quick look at Subject Activities and see how many instances of unscheduled resupply of study drug have occurred in your study thus far, at all clinical sites globally, and, in particular, at Canadian sites, where the biggest problem seems to lie. How do you quickly get the information you need from your IRT?
Solution:

Veracity Logic’s IRT solves this problem with on-screen Activity Rollup function. A toggle on the Activities page brings up a summary report filterable by Country, Site, or Activity. Activity totals are provided at the Site, Country, and Study level (as defined for your project). The same summary data is presented for all other activities, including scheduled visits and unscheduled activities (such as Screen Failures, Early Withdrawals, and Unblinding).

Subject Rollup functionality, accessible by a toggle click on the Subjects page, is also a part of Veracity Logic’s standard offering. The Subject Rollup report provides at a glance the record of all scheduled subject visits that have occurred (and their dates) within and across subjects. This report is filterable by Subject Status, Site, and Country,

Want to know more about the powerful standard offerings of Veracity Logic’s IRT?

Reaching the Help Desk…

Case Studies

Problem:

Users of your IRT are having trouble remembering how to reach the Help Desk for system and project issues. Phone numbers and email addresses are provided in various documents, but somehow your study’s site users, project managers, and site monitors –globally!–don’t seem to be able to find them when they need them, or they waste valuable time looking. How can your IRT provider ease the pain?
Solution:

Veracity Logic’s IRT provides the Help Desk email address on the system login screen and again on a Help page within the project system, easily accessible from the Main Menu. Help Desk phone numbers for each Country are listed on the Help page as well. Users literally have help at their fingertips…just click the direct email link, or pick up the phone for more urgent issues requiring immediate resolution. If your study has an IVR (phone) component as well as a web interface, users can instantly reach the Help Desk by simply hitting the star key from anywhere in the call system. At VL, we figure the point of a Help Desk is to help!

Want to know more about the powerful standard offerings of Veracity Logic’s IRT platform? Choose Contact Us from the menu above for a demo!

Real-time Integration between IWR (web) and IVR (phone)…

Case Studies

Problem:

Your global trial includes 32 clinical sites in 12 countries and all but two have reliable access to the internet and your web-based IRT system. In the other two locations, internet connectivity comes and goes like a bad dream … with entirely too much down time for the sponsor’s comfort. An IVR (phone) option is added to the IRT, meaning that users at a site, at any given time may be using either the IWR (web) or IVR (phone) platform or both … sometimes attempting to modify the same subject record. How will order be kept?
Solution:

Veracity Logic’s IRT is designed to provide instant integration between its web and phone systems when circumstances call for IVR (phone) capability. If two persons attempt to modify the same data at the same time, only the first to save their change is allowed to proceed. The other is sent an instant on-screen message (or voice message) that the data has already been modified by another user, and the new data becomes available on the phone (if entered on the web) and on the web (if entered on the phone) as soon as the user returns to the menu. The IRT’s audit trail captures the data updates made via IWR (web) or IVR (phone).

Want more details about IVR interfaces? Choose Contact Us from the menu above.

Customizing Subject Unblinding …

Case Studies

Problem:

Protocol complexities often call for a customized approach to unblinding subjects in your clinical trial. First, authorized users need to receive an on-screen message with a very specific set of instructions when they begin to unblind a subject. Second, they need to be presented with a Yes/No option to confirm that the Site Monitor or Sponsor has been alerted. Third, the user needs to request and receive an immediate authorization code from a 24-hour Medical Monitor. That code must be entered before the unblinding can be completed. And of all of this must be accomplished quickly and efficiently.

Your current IRT’s standard system allows none of these options, and the study startup clock is ticking! What to do?
Solution:

Veracity Logic’s IRT platform is designed to maximize configurability and minimize complex coding requirements for a variety of custom setups such as the ones described above. These custom unblinding modifications can be accomplished with no additional impact on project development timelines and no loss of efficiency, saving precious time, when an emergency unblind needs to occur during the study. Authorization codes are held within the IRT system; available codes are easily accessed by the designated decision makers. A code documenting permission to register the subject is provided to the Site for entry into the IRT database. The fact that an unblinding has occurred can be easily tracked by Biostatisticians. In addition, for each study, clients can specify the list of users who will receive notification of each unblinding occurrence. The content of that notification is also readily configurable for study needs.

Product Recall

Case Studies

Houston, we have a problem…

These are the words no one wants to hear! Your clinical supplies vendor has called to tell you there is a problem with one of your drug batches. You need to locate and recall all kits in the batch for destruction.

– Where are the kits with the bad drug?
– Are there any already shipped to clinical sites?
– Any, heaven forbid, assigned to subjects?