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Multi-site, multi-country clinical trials can be difficult to manage. However, an Interactive Voice Response System (IVRS), combined with the ubiquitous phone and fax services, makes study deployment fast and easy.
Swift Call's new Sydney based IVRS service now makes this capability accessible and affordable.
The IVRS allows study administrators and investigators to interact with a computer database using a telephone touchtone keypad as a means of data input. The computer is able to prompt the caller for required information with straightforward pre-recorded voice messages and also give out information in response.
The IVRS randomises treatments to subjects, provides automated confirmation of assignments, as well as regular reporting of trial progress to the researcher.
Benefits
IVRS services have gained wide acceptance because they provide real-time benefits in patient randomisation, drug assignment and inventory management, study blinding, reporting and systems integration, and low costs:
- Randomisation. Real-time feedback from a centralised database allows a researcher to dynamically allocate treatments to subject groups to better aid statistical analysis.
- Drug Assignment. Knowing where and when to allocate expensive trial drugs saves valuable resources.
- Study Blinding. IVRS helps improve the blinding process by allocating treatment groups in a controlled and unbiased manner.
- Reporting. Through automated system reports, real-time information can be made available to the study manager via fax and email.
- Systems Integration. The IVRS service and the initial study preparations and documentation fit into the familiar manual processes of organisations running clinical trials.
- Low Cost. Provided as a hosted service there is no capital expenditure required - you only pay an initial study setup fee and a low monthly fee for the provision of IVRS Service for the duration of the study.
IVRS Operation
Swift Call initially works with our clients to develop a Systems Requirements Specification for each study. Then we use pre-developed templates to speed the development of all associated documents (Worksheets, Faxes, Reports, Access Envelopes, and User Manuals).
A complete IVRS test environment is then established for final validation.
Prior to "go live" the client supplies the actual randomisation schedule and site details (centre number, hospital name, fax number, valid CRF range for the site). Swift tests the fax capabilities of each site.
Each Investigator and Administrator is given a Secure Envelope with initial Access Details and a User Manual.
On site, the Monitors and Investigators complete the Account Setup Worksheet and call the IVRS to setup their individual accounts, and they may choose their own PIN.
Subsequently, to randomise a patient to a study, Investigators call the IVRS and follow the prompts to input patient data. Upon successful stratification a Randomisation Number and a Treatment Group are assigned. A confirmation fax is then sent to the site.
Report Recipients monitor the trial progress through comprehensive & customisable periodic reports. Occasional reports are also available (eg: after 1st, 5th, 20th Randomisation) for independent statistical analysis.
Service Features
- Production of fully customised account setup worksheets and randomisation call worksheets
- Confirmation Faxes sent to Sites
- Full time demonstration system using voice prompts of the live system
- Multi-lingual voice prompts and user manuals
- Account initiation through Secure Envelopes
- Administration options for re-issuing confirmation faxes and managing user accounts
- Automated Reporting of statistics - Site Summary, Randomisation Summary, Account Usage produced weekly or monthly
- Hosted service at secure Sydney location - 24/7 monitoring
- Telephone Support
- Validated computer systems
- GAMP4 and ISO9000:2000 Quality System processes
- Staff trained in GCP.
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