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?