METHOD AND APPARATUS FOR DATABASE

A method is provided of storing in a computer memory a first plurality of database tables each of which include research data which relates to clinical or pre-clinical research studies concerning a biomedical product. The method may also include storing in the computer memory a second plurality of database tables each of which include non research data concerning the biomedical product but unrelated to clinical or pre-clinical research studies concerning the biomedical product. The method may further include linking, in the computer memory, the second plurality of database tables with the first plurality of database tables.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1shows a block diagram of components of a user computer1, and a server computer20, communicating via the internet12, for use in accordance with one or more embodiments of the present invention.

The user computer1includes a user computer memory2, a user computer interactive device4, a user computer processor6, a user computer display8, and a user computer input/output port10. The user computer interactive device4may be a computer touch screen, a computer keyboard, and/or a computer mouse, and/or any other type of computer interactive device.

The server computer20includes a server computer memory22, a server computer interactive device24, a server computer processor26, a server computer display28, and a server computer input/output port30. The server computer interactive device24may be a computer touch screen, a computer keyboard, and/or a computer mouse, and/or any other type of computer interactive device.

FIG. 2shows a diagram100of a plurality of database tables, each of which have been linked by one or more links to other database tables of the plurality of database tables, in accordance with one or more embodiments of the present invention.

The diagram100includes a plurality102of BRIDG model (Biomedical Research Integrated Domain Group model) domain based database tables. The general concept of BRIDG domain based model data base tables is known in the art. InFIG. 2, the plurality102of BRIDG domain based model database tables includes BRIDG domain based product table104, BRIDG domain based animal table106, BRIDG domain based organization table108, BRIDG domain based defined activity table110, BRIDG domain based planned activity table112, BRIDG domain based performed activity table114, BRIDG domain based adverse event table116, BRIDG domain based study protocol table118, and BRIDG domain based scheduled Activity table120. “BRIDG” domain based tables in a general sense are known in the art, however, in one or more embodiments of the present invention various data, rows, links, memory locations, columns and/or data attributes which were not previously provided in various BRIDG domain based tables have been added to BRIDG domain based tables to provide links to other tables (such as tables122,124,126,128,130, and132) which have been developed and/or created in accordance with one or more embodiments of the present invention. Each of BRIDG domain based tables104,106,108,110,112,114,116,118, and120would typically include more data rows, columns, memory locations, links, and/or data attributes than shown inFIGS. 9-17, and many of these additional data rows, columns, links, memory locations, and/or data attributes, not shown, are known in the art.

The plurality102of BRIDG model database tables may be stored in the server computer memory22, and may be downloaded from the internet12onto the user computer1, and into the user computer memory2by the user computer processor6.

InFIG. 2, one or more of the plurality102of BRIDG domain based model database tables may be linked, by one or more computer software links stored in the server computer memory22, to one or more of other BRIDG domain based model database tables of the plurality102. In the present application “linked” shall include relating or connecting two or more database tables by a computer software link stored in computer memory, such as in the server computer memory22. For example, inFIG. 2, the BRIDG domain based defined activity table110is linked to the BRIDG domain based animal table106. The BRIDG domain based animal table106is also linked to the BRIDG domain based planned activity table112, the BRIDG domain based adverse event table116, and the BRIDG domain based scheduled activity table120. The BRIDG domain based adverse event table116is also linked to the BRIDG domain based scheduled activity table120.

FIG. 2shows six database tables, which are not BRIDG domain based model database tables, and which have been created, configured, and constructed in accordance with one or more embodiments of the present invention. These six non BRIDG model database tables include animal type table122, generic product table124, trials type table126, product type table128, product category table130, and product toxicology info (information) table132. Each of the tables122,124,126,128,130, and132may be stored in the server computer memory22.

InFIG. 2, the animal type table122is linked to the BRIDG domain based animal table106. The generic product table124is linked to all nine of the plurality102of BRIDG domain based model database tables, including tables104,106,108,110,112,114,116,118, and120. The generic product table124is also linked to four of the other five tables which are non-BRIDG model tables, which includes tables126,128,130, and132. The only table the generic product table124is not linked to, directly, is the animal type table122.

The trial type table126is linked to the generic product table124, the BRIDG domain based planned activity table112, the BRIDG domain based defined activity table110, the BRIDG domain based adverse event table116, and the BRIDG domain based performed activity table120.

The product type table128is linked to the generic product table124, the product category table130, and the BRIDG domain based organization table108. The product category table130is linked to the generic product table120, the product type table128, and the BRIDG domain based organization table108. The product toxicology info table132is linked to the BRIDG domain based scheduled activity table120, the BRIDG domain based Animal table106, the BRIDG domain based performed activity table114, and the generic product table124.

FIG. 3shows a diagram which identifies the possible contents of an animal type table122which can be stored in the server computer memory22ofFIG. 1, in accordance with one or more embodiments of the present invention. In accordance with an embodiment of the present invention, a new attribute and/or row of data “animal_type_id”106fis added to the BRIDG domain based Animal table106and this links to the custom created animal type table122. This is done to help categorize the animals that are used for different trial phases.

The animal type table122includes or has associated therewith a plurality of rows and columns of data stored in memory locations or cells of the server computer memory22. In a first row, first column or memory cell or memory location122a, an indication is stored that the data in memory location122dwill be used as a computer software link to another table. In the first row, second column or memory cell or location122d, data for the variable “animal_type_id” is stored. The “X” in cell122aindicates that the “animal_type_id” is used as a computer software link to another table. In this example, the “animal_type_id” data is used to link the animal type table122with the BRIDG domain based animal table106as shown byFIGS. 2,3, and10.

The animal type table122also has associated with it, memory locations122b,122c,122e, and122f. The memory location122eincludes data regarding the name of an animal; and the memory location122fincludes data regarding the date of birth of the particular animal referred to by the data in location122dand122e. The locations122band122care blank to indicate that the data for122eand122fare not used as links to another database table in this example.

FIG. 4shows a diagram which identifies the possible contents of a generic product table124which can be stored in the server computer memory22ofFIG. 1, in accordance with one or more embodiments of the present invention. The generic product table124, in at least one embodiment, is used to store data about all products which a company manufactures, sells or obsolete products. The generic product table124, in at least one embodiment maintains data for commercial name, scientific name, status (approved sell/unapproved), potency, formulation, method of ingestion (i.e. device, stem Cell, cosmetic) and other administrative information about a product. The generic product table124may be linked to the product category table130shown inFIG. 7.

In at least one embodiment of the present invention, the data row or attribute generic_product_reference_id” is added and/or introduced into the BRIDG domain based tables108,110,112,114,116,118,104and120. This data row or attribute was not previously provided in BRIDG domain based tables. The “generic_product_reference_id” data is used as a link to the custom created generic product table124.

In at least one embodiment of the present invention, the data row or attribute “trials_type_id” is added and/or introduced into the BRIDG domain based tables110,112,114,116,118, and120. This data row or attribute was not previously provided in BRIDG domain based tables. The “trials_type_id” data is used as a link to the custom created trials type table126.

In at least one embodiment of the present invention, the data row or attribute “animal_id” is added and/or introduced into the BRIDG domain based tables110,112,114,116,118, and120. This data row or attribute was not previously provided in the specific BRIDG domain based tables referred to. The “animal_id” data is used as a link to the custom created animal type table122. In at least one embodiment, this optimizes a search path for a user, such as a user of user computer1.

The generic product table124includes or has associated therewith a plurality of rows and columns of data stored in memory locations or cells of the server computer memory22. In a first row, first column or memory cell or memory location124a, an indication is stored that the data in memory location124fwill be used as a computer software link to another table. In the first row, second column or memory cell or location124f, data for the variable “product_id” is stored. The “X” in cell124aindicates that the “product_id” is used as a computer software link to another table. In this example, the “product_id” data is used to link the generic product table124with tables104,106,108,110,112,114,116,118,120,126,128,130, and132; which is all of the other tables inFIG. 2except for the animal type table122.

The generic product table124also has associated with it, memory locations124b,124c,124d,124e,124f,124g,124h,124i, and124j. The generic product table124is configured to be displayed on a computer display, such as user computer display8or server computer display28by the computer processor6and26, respectively, ofFIG. 1, in response to computer software stored in computer memory2and22, respectively, such that scroll arrows124kand124mand scroll bar124lare displayed on computer display8and/or28. The scroll arrows124kand124mand the scroll bar124lcan be used to scroll down and/or select the data of124f-j(properties of a pharmaceutical product) to display product category linkage to a particular product as well as product type linkage for the product. In one or more embodiments, there may also be data attributes, memory locations, or rows like comparator product id not shown inFIG. 4, that are associated with generic_product table124that would be displayed. The memory location124ghas data for the name of a product. The memory location124hhas a clinical name of a product. The memory location124ihas an indication of whether the product referred to by124gand124his legal. Data indicating the strength of the product referred to by124g, is stored in memory location124j.

FIG. 5shows a diagram which identifies the possible contents of a trials type table126which can be stored in the server computer memory22ofFIG. 1, in accordance with one or more embodiments of the present invention. In at least one embodiment, the trials type table126is used to store the type of trial and link it to the BRIDG domain based defined activity table110. This link improves the usability of the overall database comprised of all of the tables and links shown inFIG. 2.

The trials type table126includes or has associated therewith a plurality of rows and columns of data stored in memory locations or cells of the server computer memory22. In a first row, first column or memory cell or memory location126a, an indication is stored that the data in memory location126dwill be used as a computer software link to another table. In the first row, second column or memory cell or location126d, data for the variable “trials_type_id” is stored. The “X” in cell126aindicates that the “trials_type_id” data is used as a computer software link to another table. In this example, the “trials_type_id” data is used to link the trials type table126with tables124,118,114,116,110,130, and128.

The trial type table126also has associated with it, memory locations126b,126c,126d,126e, and126f. The memory location126dhas data for a “trials_type_id” which is an indication of a specific trial or series of trials for a product, such as a drug trial or trials. The memory location126ehas a name of a trial stored therein. The memory location126fhas a data for a description of trial referred to in location126e, stored therein.

FIG. 6shows a diagram which identifies the possible contents of a product type table128which can be stored in the server computer memory22ofFIG. 1, in accordance with one or more embodiments of the present invention. In at least one embodiment the product type table128is a custom created table introduced to achieve categorization of a product based on usage such as whether the product is a medical device, a stem cell therapy or a formulation, a cosmetic, a food additive etc. The product type table128may have data or attributes such as product_type_id, name, and description.

The product type table128includes or has associated therewith a plurality of rows and columns of data stored in memory locations or cells of the server computer memory22. In a first row, first column or memory cell or memory location128a, an indication is stored that the data in memory location128cwill be used as a computer software link to another table. In the first row, second column or memory cell or location128c, data for the variable “product_type” is stored. The “X” in cell128aindicates that the “product_type” data is used as a computer software link to another table. In this example, the “product_type” data is used to link the product type table128with tables124,130, and108.

The product type table128also has associated with it, memory locations128band128d. The memory location128dhas data for a “type_name” which is data for a name of a specific type of product. The memory location128bis blank indicating that the data in memory location128dis not used as a link in this example.

FIG. 7shows a diagram which identifies the possible contents of a product category table130which can be stored in the server computer memory22ofFIG. 1, in accordance with one or more embodiments of the present invention.

In at least one embodiment, the product category table130stores product categorization information such as investigational, marketed, and seasonal information.

The product category table130includes or has associated therewith a plurality of rows and columns of data stored in memory locations or cells of the server computer memory22. In a first row, first column or memory cell or memory location130a, an indication is stored that the data in memory location130gfor “categories_id” will be used as a computer software link to another table. In the first row, second column or memory cell or location130g, data for the variable “categories_id” is stored, which may be a list of pharmaceutical product categories categories of products such as for example vaccine. The “X” in cell130aindicates that the “categories_id” data in130gis used as a computer software link to another table. In this example, shown by the combination ofFIG. 2andFIG. 7, the “categories id” data is used to link the product category table130with tables124,128, and108.

The product category table130also has associated with it, memory locations130b,130c,130d,130e,130f,130g,130h,130i,130j,130k, and130l. The memory location130hhas data for a “category_name” which is data for a name of a specific category of product, such as for example biological. The memory location130bis blank indicating that the data in memory location130his not used as a link in this example. The memory location130ihas data for a “description” which is data for a description of a specific category of product, such as for example created by biologic processes. The memory location130cis blank indicating that the data in memory location130iis not used as a link in this example. The memory location130jhas data for a “data_cleaned_date” which is data for a date of when data in the product category table130was last time when data was corrected (ensured that data is correct). The memory location130dis blank indicating that the data in memory location130jis not used as a link in this example. The memory location130khas data for an “approved_date” which is data for a date of approval when the product category was approved by a computer user privileged to approve the data, such as through use of the user computer interactive device4of the user computer1, meaning the data has been verified and found correct. The memory location130eis blank indicating that the data in memory location130kis not used as a link in this example. The memory location130lhas data for a “modified_date” which is data for a date of a last update to the data when the product category table130was last modified, such as by a user of the user computer1, through the user computer interactive device4. The memory location130fis blank indicating that the data in memory location130lis not used as a link in this example.

FIG. 8shows a diagram which identifies the possible contents of a product toxicology information table132which can be stored in the server computer memory22ofFIG. 1, in accordance with one or more embodiments of the present invention.

The product toxicology table132includes or has associated therewith a plurality of rows and columns of data stored in memory locations or cells of the server computer memory22. In a first row, first column or memory cell or memory location132a, an indication is stored that the data in memory location132dfor “toxicology_info_id” will be used as a computer software link to another table. In the first row, second column or memory cell or location132d, data for the variable “toxicology_info_id” is stored, which may be an identification of toxicology, for example a unique identifier for toxicology test. The “X” in cell132aindicates that the “toxicology_info_id” data in132dis used as a computer software link to another table. In this example, shown by the combination ofFIG. 2andFIG. 8, the “toxicology_info_id” data is used to link the product toxicology table132with tables124,106,120, and114.

The product toxicology information table130also has associated with it, memory locations132b,132c,132d,132e, and132f. The memory location132ehas data for “animal_id” which is data for an identification of an animal such as, a guinea pig, for example. The memory location132bis blank indicating that the data in memory location132eis not used as a link in this example. The memory location132fhas data for a “product_id” which is data for an identification of a product such as for example, acetyl salicylic acid. The memory location132cis blank indicating that the data in memory location132fis not used as a link in this example.

FIG. 9shows a diagram which identifies the possible contents of a BRIDG (Biomedical Research Integrated Domain Group) domain based product table104which can be stored in the server computer memory22ofFIG. 1, in accordance with one or more embodiments of the present invention.

The BRIDG domain based product table104includes or has associated therewith a plurality of rows and columns of data stored in memory locations or cells of the server computer memory22. In a first row, first column or memory cell or memory location104a, an indication is stored that the data in memory location104efor “product_id” will be used as a computer software link to another table. In the first row, second column or memory cell or location104e, data for the variable “product_id” is stored, which may be an indentification of a product, for example, a unique id or identification for a product. The “X” in cell104aindicates that the “product_id” data in104eis used as a computer software link to another table. In this example, shown by the combination ofFIG. 2andFIG. 9, the “product_id” data is used to link the BRIDG domain based product table104with table124.

The BRIDG domain based product table104also has associated with it, memory locations104b,104c,104d,104f,104g, and104h. The memory location104fhas data for “generic_product_reference_id” which is data for an identification of a general product such as acetyl salicylic acid. The memory location104bhas an “X” representing an indicator store in memory22, indicating that the data in memory location104fis used as a link, in this example, to the generic product table124. The memory location104ghas data for a “name” which is data for name of a product such as for example acetyl salicylic acid. The memory location104cis blank indicating that the data in memory location104gis not used as a link in this example. The memory location104hhas data for a “description” which is data for description of a product such as, for example, a pain killer. The memory location104dis blank indicating that the data in memory location104his not used as a link in this example.

FIG. 10shows a diagram which identifies the possible contents of a BRIDG domain based animal table106which can be stored in the server computer memory22ofFIG. 1, in accordance with one or more embodiments of the present invention.

The BRIDG domain based animal table106includes or has associated therewith a plurality of rows and columns of data stored in memory locations or cells of the server computer memory22. In a first row, first column or memory cell or memory location106a, an indication is stored that the data in memory location106dfor “animal_id” will be used as a computer software link to another table. In the first row, second column or memory cell or location106d, data for the variable “animal_id” is stored, which may be an identification of an animal. The “X” in cell106aindicates that the “animal_id” data in106dis used as a computer software link to another table. In this example, shown by the combination ofFIG. 2andFIG. 10, the “animal_id” data is used to link the BRIDG domain based animal table106with tables122,110,116,120,112,132,114, and124.

The BRIDG domain based animal table106also has associated with it, memory locations106b,106c,106e, and106f. The memory location106ehas data for “name” which is data for an identification of a name of an animal such as a guinea pig for example. The memory location106bis blank indicating that the data in memory location106eis not used as a link in this example. The memory location106fhas data for “animal_type_id” which is data for an identification of a type of animal such as for example an infected animal with a certain health condition. The memory location106cshows an “X” to indicate that the data in memory location106fis used as a link in this example, such as for example, linking the BRIDG domain based animal table106inFIG. 10with the animal type table122shown inFIG. 3.

FIG. 11shows a diagram which identifies the possible contents of a BRIDG domain based organization table108which can be stored in the server computer memory22ofFIG. 1, in accordance with one or more embodiments of the present invention. In at least one embodiment of the present invention the data attribute or data row for “generic_product_reference_id”108fhas been added which links to the custom generic product table124and which simplifies searching the overall database ofFIG. 2.

The BRIDG domain based organization table108includes or has associated therewith a plurality of rows and columns of data stored in memory locations or cells of the server computer memory22. In a first row, first column or memory cell or memory location108a, an indication is stored that the data in memory location108dfor “organization_id” will be used as a computer software link to another table. In the first row, second column or memory cell or location108d, data for the variable “organization_id” is stored, which may be an identification of an organization, for example a unique id for the organization. The “X” in cell108aindicates that the “organization_id” data in108dis used as a computer software link to another table. In this example, shown by the combination ofFIG. 2andFIG. 11, the “orgainzation_id” data is used to link the BRIDG domain based organization table108with tables130,124, and128.

The BRIDG domain based organization table108also has associated with it, memory locations108b,108c,108e, and108f. The memory location108ehas data for “name” which is data for a name of an organization such as a name of a hospital, for example. The memory location108bis blank indicating that the data in memory location108eis not used as a link in this example. The memory location108fhas data for “generic_product_reference_id” which is data for an identification number for a generic product such as for example, acetyl salicylic acid. The memory location108cshows an “X” indicating that the data in memory location108fis not used as a link in this example, to the custom created generic product table124shown inFIG. 4.

FIG. 12shows a diagram which identifies the possible contents of a BRIDG domain based defined activity table110which can be stored in the server computer memory22ofFIG. 1, in accordance with one or more embodiments of the present invention. In at least one embodiment, three data attributes and/or rows have been introduced and/or added to the BRIDG domain based defined activity table110. The added data attributes and/or rows are “generic_product_reference_id”110hthat links to the custom generic product table124, “trials_type_id”110fthat links to the custom trials type table126and “animal_id”110gthat links to BRIDG domain based animal table106.

The BRIDG domain based defined activity table110includes or has associated therewith a plurality of rows and columns of data stored in memory locations or cells of the server computer memory22. In a first row, first column or memory cell or memory location110a, an indication is stored that the data in memory location110efor “defined_activity_id” will be used as a computer software link to another table. In the first row, second column or memory cell or location110e, data for the variable “defined_activity_id” is stored, which may be an identification of a defined activity such as a test procedure, for example acollection of a blood sample. The “X” in cell110aindicates that the “defined_activity_id” data in110eis used as a computer software link to another table. In this example, shown by the combination ofFIG. 2andFIG. 12, the “defined_activity_id” data of110eis used to link the BRIDG domain based defined activity table110with tables106,124. and126.

The BRIDG domain based defined activity table110also has associated with it, memory locations110b,110c,110d,110f,110g, and110h. The memory location110fhas data for “trials_type_id” which is data for an identification of a trial or a series of trials, such as drug trials such as a phase two clinical trials, for example a study for comparing a new drug therapy with an existing drug therapy. The memory location110bshows an “X”, corresponding to an indicator in memory22, indicating that the data in memory location110fis used as a link in this example, to the custom trials type table126shown inFIG. 5. The memory location110ghas data for “animal_id” which is data for an identification number for an animal such as for example an identification number on an lab animal. The memory location110chas an “X” corresponding to a stored indicator in memory22, indicating that the data in memory location110gis used as a link in this example, to the BRIDG domain based animal table106. The memory location110hhas data for “generic_product_reference_id” which is data for an identification for a generic product, such as for example acetyl salicylic acid. The memory location110dshows an “X” representing a stored indicator in memory22, indicating that the data in memory location110his used as a link, in this example to custom created generic product table124ofFIG. 4.

FIG. 13shows a diagram which identifies the possible contents of a BRIDG domain based planned activity table112which can be stored in the server computer memory22ofFIG. 1, in accordance with one or more embodiments of the present invention. In at least one embodiment, three data attributes and/or rows have been introduced and/or added to the BRIDG domain based planned activity table112. The added data attributes and/or rows are “generic_product_reference_id”112hthat links to the custom generic product table124, “trials_type_id”112fthat links to the custom trials type table126and “animal_id”112gthat links to BRIDG domain based animal table106.

The BRIDG domain based planned activity table112includes or has associated therewith a plurality of rows and columns of data stored in memory locations or cells of the server computer memory22. In a first row, first column or memory cell or memory location112a, an indication is stored that the data in memory location112efor “planned_activity_id” will be used as a computer software link to another table. In the first row, second column or memory cell or location112e, data for the variable “planned_activity_id” is stored, which may be an identification of a planned activity such as a lab test, for example a blood glucose level. The “X” in cell112aindicates that the “planned_activity_id” data in112eis used as a computer software link to another table. In this example, shown by the combination ofFIG. 2andFIG. 13, the “planned_activity_id” data of112eis used to link the BRIDG domain based planned activity table112with tables124,126, and106.

The BRIDG domain based planned activity table112also has associated with it, memory locations112b,112c,112d,112f,112g, and112h. The memory location112fhas data for “trials_type_id” which is data for an identification of a trial or a series of trials, such as drug trials such as clinical trials for example a phase two clinical trial. The memory location112bshows an “X” representing an indicator stored in memory22, indicating that the data in memory location112fis used as a link, in this example, to the trials type table126. The memory location112ghas data for “animal_id” which is data for an identification number for an animal such as for example an identification number on a lab animal. The memory location112cshows an “X” representing a stored indicator in memory22indicating that the data in memory location112gis used as a link, in this example to the BRIDG domain based animal table106. The memory location112hhas data for “generic_product_reference_id” which is data for an identification for a generic product, such as for example acetyl salicylic acid. The memory location112dshows an “X” representing a stored indictor in memory22, indicating that the data in memory location112his used as a link, in this example, to the custom created generic product table124.

FIG. 14shows a diagram which identifies the possible contents of a BRIDG domain based performed activity table114which can be stored in the server computer memory22ofFIG. 1, in accordance with one or more embodiments of the present invention. In at least one embodiment, three data attributes or data rows have been created and/or added to the table114. The data attributes and/or data rows are “generic_product_reference_id”114hthat links to the generic product table124, “trials_type_id”114fthat links to the trials type table126and “animal_id”114gthat links to the BRIDG domain based Animal table106.

The BRIDG domain based performed activity table114includes or has associated therewith a plurality of rows and columns of data stored in memory locations or cells of the server computer memory22. In a first row, first column or memory cell or memory location114a, an indication is stored that the data in memory location114efor “performed_activity_id” will be used as a computer software link to another table. In the first row, second column or memory cell or location114e, data for the variable “performed_activity_id” is stored, which may be an identification of a performed activity such as a lab test, for example a blood glucose level test. The “X” in cell114aindicates that the “performed_activity_id” data in114eis used as a computer software link to another table. In this example, shown by the combination ofFIG. 2andFIG. 14, the “performed_activity_id” data of114eis used to link the BRIDG domain based performed activity table114with tables124,126,106,132, and106.

The BRIDG domain based performed activity table114also has associated with it, memory locations114b,114c,114d,114f,114g, and114h. The memory location114fhas data for “trials_type_id” which is data for an identification of a trial or a series of trials, such as drug trials such as clinical trials, for example phase two clinical trials. The memory location114bhas an “X” representing an indicator in memory22, indicating that the data in memory location114fis used as a link, in this example to trial type table126. The memory location114ghas data for “animal_id” which is data for an identification number for an animal such as for example lab animal. The memory location114chas an “X” representing an indicator in memory22, indicating that the data in memory location112gis used as a link, in this example to the BRIDG domain based animal table106. The memory location114hhas data for “generic_product_reference_id” which is data for an identification for a generic product, such as for example acetyl salicylic acid. The memory location114dhas an “X” representing an indicator, indicating that the data in memory location114his used as a link, in this example to the custom created generic product table124.

FIG. 15shows a diagram which identifies the possible contents of a BRIDG domain based adverse event table116which can be stored in the server computer memory22ofFIG. 1, in accordance with one or more embodiments of the present invention. It at least one embodiment of the present invention three data attributes and/or data rows are created and added to the BRIDG domain based Adverse Event table116. The data attributes or data rows are “generic_product_reference_id”116kthat links to the generic product table124, “trials_type_id”116jthat refers to the custom trials type table126and :animal_id”116lthat links to the BRIDG domain based animal table106.

The BRIDG domain based adverse event table116includes or has associated therewith a plurality of rows and columns of data stored in memory locations or cells of the server computer memory22. In a first row, first column or memory cell or memory location116a, an indication is stored that the data in memory location116gfor “categoryCode” will be used as a computer software link to another table. In the first row, second column or memory cell or location116g, data for the variable “categoryCode” is stored, which may be an identification of a category code such as category, for example clinical case. The “X” in cell116aindicates that the category code data in116gis used as a computer software link to another table. In this example, shown by the combination ofFIG. 2andFIG. 15, the “categoryCode” data of116gis used to link the BRIDG domain based Adverse Event table116with tables124,126,120, and106.

The BRIDG domain based adverse event table116also has associated with it, memory locations116b,116c,116d,116e,116f,116g,116i,116j,116k, and116l. The memory location116hhas data for “id” which is data for an identification number of an adverse event, such as unique identifier for an adverse event report. The memory location116bis blank indicating that the data in memory location116his not used as a link in this example. The memory location116ihas data for “summary” which is data for the summary of what the adverse event is. The memory location116cis blank indicating that the data in memory location116iis not used as a link in this example. The memory location116jhas data for “trials_type_id” which is data for an identification of a trials type during which the adverse event occurred a generic product, such as for example phase three clinical trial. The memory location116dhas an “X” representing an indicator, indicating that the data in memory location116jis used as a link, in this example to the trials type table126. The memory location116khas data for “generic_product_reference_id” which is data for an identification of a generic product that refers to this adverse event, such as for example acetyl salicylic acid. The memory location116ehas an “X” representing an indicator in memory22, indicating that the data in memory location116kis used as a link, in this example to the generic product table124. The memory location116lhas data for “animal_id” which is data for an identification of an animal, such as for example lab animal id. The memory location116fhas an “X” representing an indicator in memory22, indicating that the data in memory location116lis used as a link, in this example, to the BRIDG domain based animal table106.

FIG. 16shows a diagram which identifies the possible contents of a BRIDG domain based study protocol table118which can be stored in the server computer memory22ofFIG. 1, in accordance with one or more embodiments of the present invention. In at least one embodiment, three data attributes and/or rows have been introduced and/or added to the BRIDG domain based study protocol table118. The added data attributes and/or rows are “generic_product_reference_id”118gthat links to the custom generic product table124, “trials_type_id”118hthat links to the custom trials type table126and “animal_id”118fthat links to BRIDG domain based animal table106.

The BRIDG domain based study protocol table118includes or has associated therewith a plurality of rows and columns of data stored in memory locations or cells of the server computer memory22. In a first row, first column or memory cell or memory location118a, an indication is stored that the data in memory location118efor “study_protocol_version_id” will be used as a computer software link to another table. In the first row, second column or memory cell or location118e, data for the variable “study_protocol_version_id” is stored, which may be an identification of a study protocol version, for example initial version of phase three clinical trial. The “X” in cell118aindicates that the “study_protocol_version_id” data in118eis used as a computer software link to another table. In this example, shown by the combination ofFIG. 2andFIG. 16, the “study_protocol_version_id” data of118eis used to link the BRIDG domain based study protocol table118with table124.

The BRIDG domain based study protocol table114also has associated with it, memory locations118b,118c,118d,118f,118g, and118h. The memory location118fhas data for “animal_id” which is data for an identification of an animal such as id number for lab animal for The memory location118bhas an “X” which represents an indicator stored in memory22, indicating that the data in memory location118fis used as a link, in this example to the BRIDG domain based animal table106. The memory location118ghas data for “generic_product_id” which is data for an identification number, or alphanumeric, for a generic product such as for example acetyl salicylic acid. The memory location118chas an “X” representing an indicator in memory22, indicating that the data in memory location118gis used as a link, in this example, to the generic product table124. The memory location118hhas data for “trial_type_id” which is data for an identification of a trial type, such as for example a clinical trial. The memory location118dhas an “X” representing an indicator in memory22, indicating that the data in memory location114his used as a link, in this example to trials type table126.

FIG. 17shows a diagram which identifies the possible contents of a BRIDG domain based scheduled activity table120which can be stored in the server computer memory222ofFIG. 1, in accordance with one or more embodiments of the present invention. In at least one embodiment, three data attributes and/or rows have been introduced and/or added to the BRIDG domain based scheduled activity table120. The added data attributes and/or rows are “generic_product_reference_id”120hthat links to the custom generic product table124, “trials_type_id”120fthat links to the custom trials type table126and “animal_id”120gthat links to BRIDG domain based animal table106.

The BRIDG domain based scheduled activity table120includes or has associated therewith a plurality of rows and columns of data stored in memory locations or cells of the server computer memory22. In a first row, first column or memory cell or memory location120a, an indication is stored that the data in memory location120efor “scheduled_activity_id” will be used as a computer software link to another table. In the first row, second column or memory cell or location120e, data for the variable “scheduled_activity_id” is stored, which may be an identification of a scheduled activity such as lab test, for example blood sugar level. The “X” in cell120aindicates that the “scheduled_activity_id” data in120eis used as a computer software link to another table. In this example, shown by the combination ofFIG. 2andFIG. 17, the “scheduled_activity_id” data of120eis used to link the BRIDG domain based scheduled activity table120with tables106,132,114, and124.

The BRIDG domain based scheduled activity table120also has associated with it, memory locations120b,120c,120d,120f,120g, and120h. The memory location120fhas data for “trials_type_id” which is data for an identification of a trials type, such as clinical trials, for example phase three clinical trials. The memory location120bhas an “X” representing an indicator stored in memory22, indicating that the data in memory location120fis used as a link, in this example to the trials type table126. The memory location120ghas data for “animal_id” which is data for an identification number, or alphanumeric, for an animal. The memory location120chas an “X” representing an indicator stored in memory22, indicating that the data in memory location120gis used as a link, in this example to the BRIDG domain based animal table106. The memory location120hhas data for “generic_product_reference_id” which is data for a generic product reference identification. The memory location120dhas an “X” representing an indicator stored in memory22, indicating that the data in memory location120his used as a link, in this example, the custom created generic product table124.

FIG. 18shows a block diagram200of a clinical and pre-clinical research database202linked by a link204to a product information independent of clinical, pre-clinical research database206. The link204may actually include a plurality of links. In at least one embodiment, the link or links204may be data stored in computer memory such as computer memory2or22ofFIG. 1which links clinical, and/or pre-clinical research data in database202of a biomedical product with information independent of the clinical, and/or pre-clinical research data in database206. For example, the row, data or attribute for “generic_product_reference_id” as shown for104f,108f,110h,116k,120h, and118g, which have been added to Bridg tables, as shown byFIGS. 9-17may be stored in computer memory2or22ofFIG. 1and may be used as links for link or links204to link clinical and/or pre-clinical research database202to database206.

In addition, the generic product table124which has been created and/or configured in accordance with an embodiment of the present invention, may be stored in computer memory2and/or22, and has a row, data or attribute124ffor “generic product_reference_id”124fwhich can be a link of links204, which can be linked to non-research data (not clinical or pre clinical research) database206. The product toxicoloy information table132has row, data or attribute132ffor “generic_product_reference_id” which can also be a link of links204which link database202with database206.

Note that it is also possible that an “alias”, i.e. another name, may be used to identify the “generic_product_reference_id” in another table. Generally, the use of “aliases” is known in the art.

The tables122,126,128, and130, shown inFIGS. 3,5,6, and7, respectively, are used as lookup tables, and may be stored in computer memory2and/or22, in accordance with at least one embodiment of the present invention. The tables122,126,128, and130, in at least one embodiment, do not have a row, data or attribute for “generic_product_reference_id” and do not link directly to non research database206.

In accordance with an embodiment of the present invention, the generic product table124is a main table and is a main host for the data, row, and/or attribute “generic_product_reference_id” which is used as a link of links204from database202to database206. The “generic_product_reference_id” data, row, and/or attribute is used a a primary key, in at least one embodiment.

The database206is not shown in detail, but generally may include product commercial data for a biomedical product, said commercial data may include data about sales volume, costs, profit from sales and tax figures relating to the biomedical product which generally doesn't include rclinical and/or pre-clinical research data. The database206may also include product stability data which may be defined as data on degradation of biomedical product over a period of time, and product manufacturing data for the biomedical product which may be defined as data on product manufacturing process including raw materials, data on raw material suppliers, and manufacturing volumes.

InFIG. 18, the links204may include a combination of “generic_product_reference_id”, “animal_id” and “trials_type_id” which may help categorization of research data of database202based on different trial type for a particular biomdecial product and may be used to link database202and database206. The plurality of links204assist in categorization of data based on biomedical product and then based on animal/trial s type. In at least one embodiment, “generic_product_reference_id”, “trials_type_id” and “animal_id” links, such as links110h,110f, and110gshown inFIG. 12, are used in conjunction to allow faster and better visualization of data when data is being searched on the basis of generic product identification, animal identification or trials type identification. This categorization of data helps when users use a search method, apparatus, and/or system in accordance with an embodiment of the present invention for different types of reports like business intelligence reports, which may be part of non research data stored in database206and/or in table124in database206.

The Database206may includes product category table130shown inFIG. 7, product type table128shown inFIG. 6, product strength information and/or table not shown, product toxicology information table132shown inFIG. 8, and trials type table126shown inFIG. 5, and/or further data and/or further tables. Each of the tables inFIGS. 3-8may include further data and/or information not shown about a biomedical product.

The link204inFIG. 18between the clinical and pre-clinical research database202and the product information independent of clinical, pre-clinical research database206may be comprised of a plurality of links204from one or more Bridg tables ofFIGS. 9-17to data of database206.

For example, the link or plurality of links204may include the link108f“generic_product_reference_id” of Bridg table108ofFIG. 11. The link108fwhich has been added to a known Bridg table to form table108, in accordance with an embodiment of the present invention may link the table108with the database206. More specifically, the table108may be linked by the link108fto the generic product table124ofFIG. 4, which may be part of the database206. The generic product table124, is configured in accordance with an embodiment of the present invention to product data independent of clinical or pre-clinical research, such as name of biomedical product data124g, clinical_name data124h, “is_legal” data (for legal status of biomedical product in one or more countries)124i, and strength of biomedical product data124j.

The “generic_product_reference_id” link108fofFIG. 11, in at least one embodiment is used with respect to categorization of an organization that has been involved in trials for a particular biomedical product. In accordance with one embodiment of the present invention, the “generic_product_reference_id” link108fas used for categorization inFIG. 11, helps users of a computer software program stored in computer memory2an/or22in searching for an organization when a user provides a “generic_product_reference_id” into user computer interactive device4, as an input. The user computer processor6and/or server computer processor26is programmed by computer software in computer memory2and/or22to receive a user input “generic_product_reference_Id”, compare the input “generic_product_reference_id” with a plurality of stored “generic_product_reference_id”s. and look up information on generic product table124such as124g,124h,124i, and124jfor the input “generic_product reference_id” through link108f.

The link or plurality of links204may include links118f,118g,118hshown inFIG. 16, which link the BRIDG Domain based Study Protocol table118ofFIG. 16and the generic product table124(through links118gand124f); the BRIDG domain based Study Protocol table118to the trials type table126(through links126dand118h); and the BRIDG domain study protocol table118to the BRIDG domain animal table106ofFIG. 10(through links106dand118f). These links118f,118g, and118hassist in categorization of BRIDG domain based study protocol version data of table inFIG. 16(additional data ofFIG. 16not shown), for different trial types. For example there would be a StudyProtocolVersion for an animal say “Rat” and another StudyProtocolVersion for “Human”. Also there would be different StudyProtocolVersion for different phases of Human trials like phase one to phase four and “trial_type_id” of link118h, which has been added in accordance with an embodiment of the present invention, helps in categorization of the same. One or more embodiments of the present invention help in this categorization of data which would be very useful for data visualization by end users of our a computer software program implemented by computer processors6and/or26and stored in computer memories2and/or22in accordance with an embodiment of the present invention, for business intelligence reports.

The link or links204ofFIG. 18, may include links116j,116k, and116lshown inFIG. 15for Bridg Adverse Event table116. The links116j,116k, and116l, have been added in accordance with an embodiment of the present invention to computer memory, such as2and/or22, to connect the BRIDG Domain based AdverseEvent table116and commercial database tables of database206, such as generic_product table124, trials type table126, and BRIDG Domain based animal table106ofFIG. 10. The links116j,116k, and116lassist in categorization of BRIDG domain based AdverseEvent data for different trial type. For example there would be a Adverse Event for an animal say a “Rat” and another Adverse Event for a “Human”. Also there would be different Adverse Events for different phases of human trials like phase one to phase four and “trial_type_id” link116jhelps in categorization of the same. One or more embodiments of the present Invention helps in this categorization of data which is very useful for data visualization by end users of a computer software program implemented by computer processors6and/or26and stored in computer memory2and/or22, such as for business intelligence reports. The Adverse Event categorizations of table116inFIG. 15, is extremely useful to life sciences companies and plays a role in the success of any drug, medical device, or Therapy.