Prelude Computer Solutions, Inc.

  Clinical Supply Inventory Tracking and Reporting

The Clinical Supplies Inventory Tracking and Reporting software tracks and reports on all aspects of the production and distribution of supplies for multiple protocols and multiple investigators.

Clinical Supplies Inventory by Investigator and Protocol

When the clinical trial product is manufactured, information is captured in the inventory master such as quantity, package type, lot number, etc.  This manufactured product can then be distributed directly to the trial or sent to multiple external distributors for shipment. In order to track all aspects of the supply distribution, two master files are established.

  • Investigator Master - this table contains all the investigators and their relevant contact information

  • Protocol Master - this table contains all protocol information such as protocol number, description and indication.

As requests for supplies are received from investigators, the fulfillment is tracked in the inventory module by manufacturing run and distributor, thus maintaining an accurate inventory as well as statistics on usage by investigator and protocol. 

Clinical Supplies by Patient

In some cases the FDA will authorize the use of a drug by a doctor that is potentially harmful to the patient under certain conditions and must therefore be monitored very closely. 

The supplies by patient module provides for tracking all supplies issued to an investigator by patient.  Before the supplies can be distributed, the investigator must submit documentation that the patient does not have the preexisting condition.  For example, certain cancer protocols might be dangerous for pregnant females and therefore a pregnancy test might be required before administration of the drug. 

Reports and Customization

Several standard reports on inventory status, distribution and requisition are provided.  We understand that your clinical trial supply requirements may differ from the packaged application and we will work with you to insure that your requirements are met. 

 

 

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