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To
monitor the number and the timing of
drug delivery during a clinical trial
can be done from now on !!! Thanks to
the dispenser unit concept, called Izzo®
System, developped by Physior.
Altogether, a four year product development
project and an investment of more than
1,5 million (Euros).
The objective
:
To improve the monitoring of patient
compliance, indeed, compliance has
a key impact on trials results.
Up to now,
the tools available to monitor compliance,
only measured the mechanical process
of drug delivery. Those systems do
not record if the medicine was released,
and how many units were released.
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Izzo® System accurately
records patient compliance :
- Time of drug delivery
- Number of drug delivery.
For the first time, Izzo®
System records and monitors the drug progress
from its loading to the intake. Izzo®
System is made of 4 integrated elements.
Safe and secure
Loader Unit
Can hold up to 14 tablets or capsules
up to size 0.
The loading unit is made of 14 separately
identified compartments to store the therapeutic
units, individually .
Safe and secure (no access to the medicine
without the dispenser unit).
The patient can only have access to the
drug intake in the order planned by the
procedure (he cannot interfere with the
order of the drug delivery) – indeed,
the loading unit rotates twice only : for
filling and for product delivery.
A « Clever
» Dispenser Unit
It delivers one drug unit at a time. It
records the date and time of each drug intake
It records the physical entry of the medicine
( no false positive / no false negative)
The dispenser unit can hold up to 4 different
products. It records the date and time of
drug intake ( up to 3000 tablets delivery
over 24 months) and visualise physical entry
of the therapeutic units.
It releases one dose of medicine, the loader
unit rotates after each action on the lever.
The rotating mechanism gets blocked at the
end of the 14 drug intake.
Data is stored and will not be lost even
in the event of a battery failure (length
of use : 24 months).
A unique identification number will appear
for each check and report print-outs.
DTM module
From the dispenser unit to a computer,
this software enables the clinician to follow-up
patient compliance when checking the unit.
Patient Compliance
Report
Key element of the Izzo® System
It is edited via a proprietary software.
To obtain individual or group compliance
data.
The data is SAS or Excel format compatible.
Transparency willingness
The Izzo® System equipment is available
to rent only. The data is then analysed
by Izzo® System, the results are issued
on a CD-ROM, as a proof of the transparency
of the system.
The proprietary software analysing the data
is not accessible for reasons of total security.
All the dispensing units are systematically
checked to guarantee their quality and reliability
The Izzo system
reliability has been proven through many
protocols:
Beaufour, Roche, Parke-Davis, Servier, Bellon,
Bayer, Inserm ( Medical Pharmacology Laboratory
in Clermont-Ferrand, France), the Technology
Development Center of the Howard and Georgeanna
Fondation, Norfolk Virginia, USA »
Up to now, Izzo® System
has successfully recorded and analysed more
than 150 000 drug intakes. |
