Interactive Voice Response System
Full-featured IxRS Services
Lifetree via Synteract has the ability to offer full-featured global Interactive Voice and Web Response Systems, better known as IxRS, through our fully validated 21 CRF Part 11 compliant proprietary system. Once implemented, the system is available 24/7 for use by sites, study participants and project team members. Transactions are recorded into a study-specific database, and information can be exported into custom reports. Live technical support is available to sites and study participants via phone, email or Web access.
IxRS services include:
Randomization
Our expert team of statisticians and IxRS programmers can develop permuted block and dynamic algorithms to suit the needs of any study. The system automatically provides real-time confirmation (by fax or email) of randomization activity.
Patient diaries
Study participants can use the system to enter diary information or quality of life questionnaire responses. All data entries are time-stamped for audit trails and immediately entered into the database to become available for analysis and review.
Automated call-outs and reminders
The IxRS can be programmed easily to handle outbound calls to sites or study participants to remind them of critical requirements.
Clinical trial material inventory management
Automated inventory management is a natural extension of automated randomization, providing accurate treatment assignment as well as supply distribution and tracking. Careful inventory management can reduce the use of drug inventory by as much as 50 percent. IxRS-based, full inventory management capabilities include:
- Treatment kit assignment
- Treatment kit re-supply
- Expiry tracking
- Just-in-time distribution
System security and back up
The IxRS authenticates each caller by dial-in number, user ID, and password. User IDs and passwords are assigned and securely distributed upon site activation. As standard procedure at Synteract, all databases, files and programs are backed up each night (full increments) and then sent twice weekly to secure off-site storage as part of disaster recovery measures.
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