1. It’s like alphabet soup – what do all the initials mean?
- IVRS is Interactive Voice Response System – this is what is usually referred to as voice menus (“Press 1 for this, Press 2 for that”), and we use those functions to allow patients to input detailed answers to trial-related survey questions.
- IWRS is Interactive Web-based (or Web-board) Reporting System– this is the part of the system that the trial site and the sponsor use to see the results of patient input
- ePRO – Electronic Patient Reported Outcomes – uses IVR and IWR to capture and report all this trial data from patients
- EDC is Electronic Data Capture, or another way to describe the IVR-IWR system as a whole
2. How do you implement IVR systems for a trial?
- Criterium hosts our IVR applications in Boca Raton, Florida. We contract with a toll free forwarding company to take international calls and forward them to the Florida Data Center. This means we are able to provide a local number anywhere on the Globe that is then transferred to Florida. Once the application is moved into a production environment the focus of technical support is making sure the IVR will pick up when called.
- The system manager in Florida utilizes automated monitoring software in conjunction with manual testing of the production applications. Someone on the study team will be trained and involved throughout the development, testing and deployment process so they will have a good understanding of the application as a whole. That will allow the project member to respond quickly to questions from the client.
3. Have IVRS systems replaced IWRS systems — or vice versa?
- No, the IVRS and IWRS systems are built to complement each other. Both systems access the same database so they are really just two portals into the same information.
- IVRS is better suited for situations where there is limited internet access or the type of information being collected is minimal and concise, such as patient diaries, patient registration or randomization.
- IWRS is better suited for reporting and entering textual information, such as comments, and where internet access is stable.
- The IWRS can do anything the IVRS can do, while the IVRS is limited to what can be entered via telephone keypad entries.
4. Does Criterium have its own servers?
- Yes, we have our own servers and all necessary equipment to handle large volumes of phone calls and web applications. We have a strong investment in the infrastructure. We have redundant internet and phone circuits as well as servers. Our server room has backup power supply and is in a very secure location.
5. Which is most cost effective – IVR or IWR?
- That depends on the application. Usually the IWRS is built first to allow administrative functions (site maintenance, login maintenance, reporting, and more) and then the IVR registration / randomization of subjects is added. Since it is tailored to every specific trial’s requirements, it’s easier to say that it’s a real-time data advantage that you can’t afford NOT to have!
Read more about EDC from Greg Bailey:
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