Drug document production system
AssigneeMichael Umen & Co., Inc.
InventorsMichael J. Umen, Kathy J. Nomides, Phillip C. Wilson, Erik A. Martin
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Abstract
A document production system is provided for preparing documents and managing a database of information pertaining to investigational studies of medical products. The document production system includes a data management user interface for providing user access to the database and for retrieving information from the database as specified by selected document templates for placement into word processor-compatible documents. Additionally, the data management user interface is capable of updating information stored within the database in accordance with information specified within a previously-prepared document.
Claims4
An apparatus for producing a document for regulatory review of a drug, comprising:
- a first electronic document template corresponding to a first regulatory authority for approving use of the drug within a first jurisdiction;
- a second electronic document template corresponding to a second regulatory authority for approving use of the drug within a second jurisdiction;
- a data storage system for storing said first and second templates and for storing a database for containing information pertaining to investigational studies of the drug;
- a computer connection with the data storage system, the computer configured to execute a data management interface integrated with a word processor, for storing and retrieving information in the database, and for composing said information to form the document on the basis of a selected one of said first and second templates;
- and
- wherein said data management interface is configured to generating a status report indicating a status of completion of said information stored in the database.
An apparatus for producing a document for regulatory review of a drug, comprising:
- a first electronic document template corresponding to a first regulatory authority for approving use of the drug within a first jurisdiction;
- a second electronic document template corresponding to a second regulatory authority for approving use of the drug within a second jurisdiction;
- a data storage system for storing said first and second templates and for storing a database for containing information pertaining to investigational studies of the drug;
- a computer connection with the data storage system, the computer configured to execute a data management interface integrated with a word processor, for storing and retrieving information in the database, and for composing said information to form the document on the basis of a selected one of said first and second templates;
- and
- wherein said database is configured to store alternative versions of a data item pertaining to the drug, and wherein the data management interface is arranged to select a corresponding one of said versions for inclusion in the document on the basis of the selected template.
Dependencies are inferred from the claim text.