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Java Software for Investigational Drug Clinical Research

Posted Feb 20 2013 7:00pm

Description of Invention:
A Java based software application available for academic use and on a royalty-bearing basis for commercial licensing. The Investigational Drug Management System (IDMS) supports the operational needs of the investigation drug section of a pharmacy providing inventory management functions which fulfill the record-keeping requirements defined in the Code of Federal Regulations related to the storage, labeling, handling, and dispensing of investigational drugs. The internet/browser based application interfaces with the Computerized Provider Order Entry (CPOE) system for tracking patients and prescriptions for investigational drugs. The IDMS supports the prescription filling process by capturing real-time data during the dispensing activity where automated safety checks are performed, ensuring the “five rights” of medication use are satisfied. The system supports randomized double-blind clinical trials by generating complex, multi-tiered randomization schemes that produce patient-specific treatment assignments along with industry standard labels containing barcodes. IDMS serves as the book of record providing end-to-end traceability for the receipt of raw materials from their source to the dispensing of finished pharmaceutical dosage forms to patients.

Applications:
  • Clinical data management
  • Clinical Trials
  • Investigational new drug trials


Advantages:
  • Web based
  • User friendly
  • Data portability
  • Randomization tables


Development Status:
  • Prototype
  • Clinical


Inventors:
Richard O DeCederfelt (CC)
George J Grimes (CC)
Stephen M Bergstrom (CC)
Jon W McKeeby (CC)


Patent Status:
HHS, Reference No. E-063-2013/0

Research Tool – Patent protection is not being pursued for this technology.


For Licensing Information Please Contact:
Michael Shmilovich Esq.
NIH Office of Technology Transfer
6011 Executive Blvd. Suite 325,
Rockville, MD 20852
United States
Email: shmilovm@mail.nih.gov
Phone: 301-435-5019
Fax: 301-402-0220


Ref No: 2530

Updated: 02/2013

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