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.
Clinical data management
Investigational new drug trials
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: firstname.lastname@example.org Phone: 301-435-5019 Fax: 301-402-0220