WO2006121451A3 - Software architecture and system for performing validated clinical studies of pharmaceutical related products - Google Patents

Software architecture and system for performing validated clinical studies of pharmaceutical related products Download PDF

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Publication number
WO2006121451A3
WO2006121451A3 PCT/US2005/025481 US2005025481W WO2006121451A3 WO 2006121451 A3 WO2006121451 A3 WO 2006121451A3 US 2005025481 W US2005025481 W US 2005025481W WO 2006121451 A3 WO2006121451 A3 WO 2006121451A3
Authority
WO
WIPO (PCT)
Prior art keywords
documents
data collection
document
clinical studies
tracking
Prior art date
Application number
PCT/US2005/025481
Other languages
French (fr)
Other versions
WO2006121451A2 (en
Inventor
Thomas Wood
Original Assignee
Clinisys Inc
Thomas Wood
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US10/264,919 external-priority patent/US6925599B2/en
Application filed by Clinisys Inc, Thomas Wood filed Critical Clinisys Inc
Priority to PCT/US2005/025481 priority Critical patent/WO2006121451A2/en
Publication of WO2006121451A2 publication Critical patent/WO2006121451A2/en
Publication of WO2006121451A3 publication Critical patent/WO2006121451A3/en

Links

Classifications

    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/06—Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H70/00—ICT specially adapted for the handling or processing of medical references
    • G16H70/40—ICT specially adapted for the handling or processing of medical references relating to drugs, e.g. their side effects or intended usage

Abstract

Software, and a master system with hardware and connections, for validated drug clinical studies includes: creating data collection documents with unique identifiers; having operators complete security identification verification before proceeding; having secured operators fill out and sign specified data collection documents; creating permanent records of the preceding; tracking by unique identifiers in a local system; uploading to a central system; independently reviewing filled out signed data collection documents to accept or require clarifications; keeping permanent read only records of all originally filled out and signed documents; making document clarification requests; reviewing each response; assigning new unique identifier links to each version of every revision; iteratively repeating the above until the documents are clean, and storing and tracking every version of every document in the central system; providing a monitor query and document entry history of all changes to all documents to create a secured audit trail.
PCT/US2005/025481 2002-10-04 2005-07-18 Software architecture and system for performing validated clinical studies of pharmaceutical related products WO2006121451A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2005/025481 WO2006121451A2 (en) 2002-10-04 2005-07-18 Software architecture and system for performing validated clinical studies of pharmaceutical related products

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/264,919 US6925599B2 (en) 2002-10-04 2002-10-04 Methodology for performing validated clinical studies of pharmeceutical related products
PCT/US2005/025481 WO2006121451A2 (en) 2002-10-04 2005-07-18 Software architecture and system for performing validated clinical studies of pharmaceutical related products

Publications (2)

Publication Number Publication Date
WO2006121451A2 WO2006121451A2 (en) 2006-11-16
WO2006121451A3 true WO2006121451A3 (en) 2008-10-30

Family

ID=37397007

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2005/025481 WO2006121451A2 (en) 2002-10-04 2005-07-18 Software architecture and system for performing validated clinical studies of pharmaceutical related products

Country Status (1)

Country Link
WO (1) WO2006121451A2 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107729507B (en) * 2017-10-23 2020-06-05 广州慧睿思通信息科技有限公司 Data cleaning method based on terminal storage and nearby calculation

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5867821A (en) * 1994-05-11 1999-02-02 Paxton Developments Inc. Method and apparatus for electronically accessing and distributing personal health care information and services in hospitals and homes
US6230142B1 (en) * 1997-12-24 2001-05-08 Homeopt, Llc Health care data manipulation and analysis system
US6820235B1 (en) * 1998-06-05 2004-11-16 Phase Forward Inc. Clinical trial data management system and method

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5867821A (en) * 1994-05-11 1999-02-02 Paxton Developments Inc. Method and apparatus for electronically accessing and distributing personal health care information and services in hospitals and homes
US6230142B1 (en) * 1997-12-24 2001-05-08 Homeopt, Llc Health care data manipulation and analysis system
US6820235B1 (en) * 1998-06-05 2004-11-16 Phase Forward Inc. Clinical trial data management system and method

Also Published As

Publication number Publication date
WO2006121451A2 (en) 2006-11-16

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