Interactive Voice Response Systems (IVRS)

Criterium has been a pioneer in the development of custom-designed patient diaries and Interactive Voice Response Systems (IVRS) to meet the specific needs of our clients for more than 15 years. Criterium develops, implements, and monitors all aspects of IVRS as required.

The use of telephone (“TeleDiary™”) and Web-based response systems have proven to be more efficient and cost-effective than standard paper diaries. Additionally, TeleDiary™ is a superior method to paper diaries for both obtaining data and maintaining the integrity of data. Numeric data are available immediately; voiced qualitative data are compiled and available the next day.

A major client benefit is cost-effectiveness, as the use of TeleDiary™ involves no new hardware or software expense or maintenance by the client. Criterium personnel design the questionnaire and program all applications into a secure computer system. Patients their record responses via a touch-tone keypad into that computer via secured 800 numbers. All information reported in an IVR diary is available to our clients and sites as it is being gathered through our secure Web Access or Virtual Private Network (VPN). Clients further have the advantage of Criterium’s 24-hour help desk, with worldwide support for their studies. The resultant cost savings from reduced travel time to sites can be substantial.

Criterium’s IVR systems provide real-time data tracking for:

• Patient registration
• Randomization
• Patient response diaries
• Clinical trial management

Remote data management using IVR systems combines the process of collection, correction, and database locking, and provides an audit trail that is not possible with standard paper diaries.

Criterium offers IVR as part of a comprehensive study management plan or for a single service. The IVR system enables Criterium to provide daily tracking and reporting of data, as well as recommendations to augment the study based on up-to-the-minute analysis.

I) IVR Diaries for Patient Randomization and Drug Tracking: Features, Benefits, and Applications

A) Features:

• Real-time automated inventory control
• Patient registration
• Automatic patient randomization
• PIN security
• 21 CFR Part 11 compliant
• 24/7/365 international toll-free availability

B) Benefits:

• More patients can be randomized with less drug supply
• Greater adherence to randomization sequence in drug dispensation
• Control over drug supply at each site
• Immediate notification of patient enrollment statistics
• Greater control of patient compliance during screening and washout

C) Applications:

Criterium, Inc. recently completed an international study involving 40 sites. Because the drug supply was limited, the IVR was extremely important. By monitoring the number of patients screened at all sites, Criterium was able to identify the low-enrolling sites and remove and redistribute the drug supply. Using IVR technology, we were able reassign the drug kits to another site as soon as they had passed through quality control. This procedure was so efficient that all eligible screened patients were enrolled. The study was completed successfully with less than 10% of active study drug kits remaining.

II) IVR “TeleDiary™”: Features, Benefits, and Applications:

• Real-time patient reporting
• Automatic data edit checks
• Algorithms customized per protocol
• Multilingual translations
• Automatic study qualification reporting
• PIN security
• 21 CFR Part 11 compliant
• 24/7/365 international toll-free availability

B) Benefits:

• Greater patient compliance
• When used as a screening tool, noncompliant patients can be filtered out prior to randomization
• Real-time compliance analysis enables an early prediction of enrollment requirements
• Improved quality of data
• Reduces manual processing

C) Case Study:

Criterium, Inc. conducted a study that required an outcome of 600 patients. Although call-in compliance was consistently more than 90%, we were able to determine that not all of the statistical requirements were being met in approximately 10% of the patients. To meet the outcome requirements of the study, we determined a minimum of 100 additional patients needed to be enrolled. Because we were able to identify the problem early in the process, this decision did not impact the timelines or cost of the study. We were able to plan accordingly with the client and distribute our resources strategically for a successful completion.