Patent ID: 6205455
Filing Date: 2001-03-20
Classification: G06F,G06Q,G16H,Y10S

Abstract:
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; andwherein said data management interface is configured to generating a status report indicating a status of completion of said information stored in the database.