Product/Service

IVRS/IWRS Services

Source: SynteractHCR

SynteractHCR

SynteractHCR offers full-featured global Interactive Voice and Web Response Systems for your clinical trial operations, through our 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. SynteractHCR has successfully implemented IWRS in 30 countries and has the capability to translate 26 different languages.

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IWRS services include:

Randomization

Our expert team of statisticians and IWRS programmers can develop permuted block and dynamic algorithms to suit the needs of data management for clinical trials. 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 IWRS can be programmed easily to handle outbound calls to sites or study participants to remind them of critical requirements.  These “reminder-calls” are an excellent method of improving patient diary completion and compliance rates.

IWRS-based, full clinical trials management of inventory includes:

  • Treatment kit assignment
  • Treatment kit re-supply
  • Expiry tracking
  • Just-in-time distribution

System Security and Backup

The IWRS authenticates each caller. User IDs and passwords are assigned and securely distributed upon site activation. As standard procedure for clinical trials management at SynteractHCR, 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. At SynteractHCR you can feel secure knowing we rescue studies, and your study will never need to be. Your clinical trial operations will be handled correctly from start to finish - our high percentage of repeat and referral business proves it.

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