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Multi-site, multi-country clinical trials can be difficult to manage. However, an Interactive Voice Response System (IVRS)
combined with ubiquitous phone and fax services, or an Interactive Web Response System (IWRS) using a standard web browser and email service,
allows study administrators and investigators to securely interact with the study database, making study deployment fast and easy.
Both services can be accessed from any location
worldwide and, for flexibility, you can choose to implement
both of these technologies concurrently in any study.
When used for Patient Randomisation, 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 (in any language) and give out information in response.
Similarly, the IWRS assigns treatments to subjects, provides automated confirmation
of assignments (on screen and via email), as well as regular reporting of trial progress to the researcher.
With online interactions the IWRS system expands on the depth of detail that an investigator or administrator is able to
obtain about the progress of the trial compared to that available through IVRS.
Both services randomise treatments to subjects,
provide automated confirmation of assignments, as well as
regular reporting of trial progress to the researcher. All
this is done on a 24/7 basis, eliminating the issues of time-zones
and distance.
Benefits
IVRS and IWRS have gained wide acceptance because they provide
real-time benefits in Patient Randomisation, drug assignment
and inventory management, study blinding, reporting, 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/IWRS 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/IWRS 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 Services for the duration of the study.
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