Clinical Trial Materials Supply Management
The Clinical Trial Supply Software uses a simulation
model integrated with spreadsheet input/output capability to
manage the flow of materials through all phases of the supply
chain. The manufacturing processes for active materials,
drug product, packaged product and patient kits are all included
in a synchronized flow. Inventory may be monitored at each
point in the chain and replenishment rules established for each
plant or work center involved. As in
other models described for commercial biotech and pharmaceutical or other
manufacturing, each work center may be modeled down to the
individual piece of equipment. A high level model of the
flow includes the capability to "drill down" into each work
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View a 1 minute video
example of an actual clinical trial supply simulation
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Brochure
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Best Practice in Clinical SCM
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When the model is run, graphics and metrics are
available that may be selected as needed. In this example,
the timing of batches and lots in the production flow are shown
from drug substance to drug product to packaged products and
kits. It is also possible to measure how long kitted
product has been in the clinical trial pipeline since each lot
is time stamped as it goes through each process. |
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The demand for patient kits is based on the
patient clinical trial recruitment rate, and the usage for the clinical drug
trial. The usage is calculated based on the size of kits, which dictates
how long a kit will last and when reorders from patients will be required.
In addition to the normal duration of the trial for each patient, the
patient drop-out rate experience is also factored in since that product is
also used during the course of the FDA clinical trial.
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Brochure
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Patient recruitment is a
driving factor in the management of the clinical trial
supply chain. The plan for global clinical trial
recruitment may be used to run scenarios for the timing
of inventory buildup and production capacity.
Actual recruitment on a weekly is then tracked against
the original forecast
so
that the clinical trial manager and clinical trial
coordinator have information to take necessary action to
assure the right level of inventory is available.
Inventory must be available at distribution points for
patients in the trial, but too much may result is the
costly disposal of lots that may reach their expiration.
The actual
recruitment may be maintained in a database or
spreadsheet and fed directly into the model. In
this example, the red line depicts the planned rate of
clinical trial recruitment. The blue
line depicts the actual rate, and a statistical
projection for the future periods based on the weekly
actual to forecast experience.
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Brochure
(PDF)
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The demand for patient
kits is based on the patient clinical trial recruitment
rate, and the usage for the clinical drug trial.
The usage is calculated based on the size of kits, which
dictates how long a kit will last and when reorders from
patients will be required. In addition to the
normal duration of the trial for each patient, the
patient drop-out rate experience is also factored in
since that product is also used during the course of the
FDA clinical trial.
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Clinical trial management can be greatly improved
with the ability to predict when and how much drug product is
needed over the course of the pharmaceutical clinical trial.
The clinical trial manager has the option to perform "what if"
scenarios for various capacity, resource and replenishment rules
across the clinical trial service points in the supply chain.
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Brochure
(PDF)
Request Web Demo
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After the pharmaceutical clinical trial phase,
these capabilities may also be applied to the follow-on phases
for pilot plant ramp-up to commercial manufacturing.
They may also be used for a medical device clinical trial
process as well. The equipment and processes involved are
modeled with modular structures in the clinical trail software
that are generic to the clinical trial process. |
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Pharmaceutical Manufacturing |
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