Supply Simulation, Process Optimization, Lean Design
 
S e c t i o n

Read the cover story Managing the Global Clinical-Trial Materials Supply Chain in the November 2011 issue of Pharmaceutical Technology with an interview of OpStat's Jim Curry

 

 

 

 

 

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 center.

View a 1 minute video example of an actual clinical trial supply simulation

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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.  

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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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.  

 
 

Brochure   (PDF)

 

 

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.

 

 
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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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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