1. A method of producing a document for regulatory approval of a drug, comprising: conducting a plurality of clinical studies of the drug; entering data objects pertaining to the clinical studies into a database; providing a document template having delimited data fields for insertion of data objects; providing a user interface for selection of a subset of said clinical studies to be reported in the document; scanning the database to provide a status report indicating whether the data objects for the selected studies conform to a predetermined completion criteria; extracting data objects pertaining to the selected studies from the database inserting the extracted data objects into the document template to generate a document compatible with a document publishing system; and publishing the generated document.