![]() |
||||||||||||
|
||||||||||||
|
Corporate
Safety
Clinical
Clinical Trial Monitor & Audit Manager
Clinical Supply Inventory Tracking & Reporting
Clinical File Room
Regulatory
FDA-2657 DPL
Medical Device Listings
International Certificates
European & Safety Tracking
Submission Tracking
Project & Financial Management
Consulting Projects
SharePoint Consulting & Services
Records Management Strategy & Guidance
Document Management Consulting
|
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.
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.
|
||||||||||||
|
Return to Home Page . Copyright 2009 Prelude Computer Solutions, Inc. All Rights Reserved. |
||||||||||||