Test management system for providing dashboard

Abstract

The present invention relates to a test management system for managing, through a dedicated application, a process of requesting and conducting test services in the field of life science, the test management system comprising: a manager terminal used by a manager of a company that produces and provides the dedicated application; a CRO master terminal used by managers including a team leader and a sales representative of a CRO company that has been commissioned to provide the test service; a CRO terminal used by a person in charge who performs tests at the CRO company; a client terminal used by a client company representative who has commissioned the test service to the CRO company; and a server that provides the dedicated application to the manager terminal, the CRO master terminal, the CRO terminal, and the client terminal, provides various functions related to the tests through the dedicated application, and enables real-time sharing of data and information. According to the present invention, tests can be easily and quickly conducted, thereby contributing to the convenience of CRO companies, client companies, and the like involved in the tests.

Description

Test management system that provides a dashboard

[0001] The present invention relates to a test management technology in the bio field, and more specifically, to a technology for sharing and managing a test process in real time between a service requesting client and a test analysis organization (CRO, Contract Research Organization).

[0002] The Korean pharmaceutical market currently strives to conduct evidence-based research on numerous products and enhance brand value through these findings. However, the significant research effort and budgetary burdens associated with such trials pose challenges. Furthermore, the majority of trials conducted on the market today typically involve post-market surveillance, researcher-led trials, and pharmaceutical company-led trials, making it difficult to conduct diverse research.

[0003] For example, a biopharmaceutical company files an Investigational New Drug (IND) application with the relevant agency (e.g., the Korean Food and Drug Administration (KFDA)) to obtain approval for a phase 1 clinical trial. The IND application typically includes a comprehensive nonclinical trial performance report. Nonclinical studies (in vivo and in vitro) submitted for IND applications must comply with Good Laboratory Practice (GLP) regulations, and the study report must document whether the study complied with GLP regulations. These critical elements must be properly discussed and confirmed between the study sponsor and the study performer. Furthermore, it must be confirmed that each study complied with regulatory guidelines, and the identity of the person responsible for evaluating the study results and concluding that it was safe must be identified.

[0004] To reduce costs and facilitate testing, pharmaceutical companies are increasingly contracting with contract research organizations (CROs) or test analysis institutions to outsource testing and carry out testing on their behalf.

[0005] The current state of domestic CROs is diverse, ranging from large foreign companies to small businesses. Due to the nature of their business, which involves providing services through human resources, CROs of various sizes exist, including individual businesses.

[0006] Large foreign CROs use proprietary management software to share and report test results and other related documents in real time with their clients. However, this proprietary management software is tailored to the specific CRO company, so it lacks general usability. Furthermore, the software lacks direct communication features like chat functionality, making it difficult for clients to contact CRO representatives.

[0007] Additionally, for small and medium-sized CRO companies, developing their own software for test management is burdensome in terms of human resources and investment, and it is difficult to quickly produce it to suit the company's circumstances.

[0008] The present invention has been devised to solve the above problems, and its purpose is to provide a test management system that can share the test progress in real time and report the results between a client who has requested a test service and a CRO company, which is an institution that has been commissioned to perform the test.

[0009] The purpose of the present invention is not limited to the purposes mentioned above, and other purposes not mentioned will be clearly understood by those skilled in the art from the description below.

[0010] In order to achieve the above object, the present invention relates to a test management system that manages the process of requesting and conducting test services in the field of life sciences through a dedicated application, and comprises: an administrator terminal, which is a terminal used by an administrator of a company that produces and provides the dedicated application; a CRO master terminal, which is a terminal used by an administrator including a team leader and a sales representative of a CRO company that has been requested to provide the test service; a CRO terminal, which is a terminal used by a person in charge of performing a test at the CRO company; a client terminal, which is a terminal used by a person in charge of a client company that has requested the test service to the CRO company; and a server that provides the dedicated application to the administrator terminal, the CRO master terminal, the CRO terminal, and the client terminal, provides various functions related to the test through the dedicated application, and allows data and information to be shared in real time, and the server grants different permissions to the administrator terminal, the CRO master terminal, the CRO terminal, and the client terminal that log in through the dedicated application, and provides different functions according to the permissions, and the server provides a dashboard function that visualizes and displays information related to test management on a screen through the dedicated application.

[0011] In providing the dashboard function, the above server may provide an individual project dashboard function that displays information including the progress status and progress results for individual projects undergoing testing.

[0012] The above server can provide the above individual project dashboard function to the above administrator terminal, the above CRO master terminal, the above CRO terminal, and the above client terminal.

[0013] In providing the above dashboard function, the above server can provide an overall project integrated management dashboard function that displays the progress and progress results of the entire project being tested.

[0014] The above server can provide the above-mentioned overall project integration management dashboard function only to the above-mentioned CRO master terminal.

[0015] According to the present invention, by sharing the test service process in the life science field in real time, tests can be conducted easily and quickly, and there is an effect of contributing to the convenience of CRO companies and clients related to tests.

[0016] Furthermore, the present invention provides key trial-related information in a dashboard format, allowing users to view project progress and results at a glance, contributing to user convenience. In particular, CRO managers can gain insight into non-clinical CRO project management and operations through the integrated project management dashboard, facilitating quick decision-making and processing.

[0017] FIG. 1 is a block diagram schematically illustrating the structure of a test management system according to one embodiment of the present invention.

[0018] Figures 2 to 53 are examples of dedicated application screens provided by a test management system according to one embodiment of the present invention.

[0019] Figures 54 to 63 are examples of dashboard screens in a dedicated application provided by a test management system according to one embodiment of the present invention.

[0020] The present invention is susceptible to various modifications and embodiments. Specific embodiments are illustrated and described in detail in the drawings. However, this is not intended to limit the present invention to specific embodiments, but rather to encompass all modifications, equivalents, and alternatives falling within the spirit and technical scope of the present invention.

[0021] The terminology used in this application is only used to describe specific embodiments and is not intended to limit the present invention. The singular expression includes the plural expression unless the context clearly indicates otherwise. In this application, it should be understood that the terms "comprise" or "have" indicate the presence of a feature, number, step, operation, component, part, or combination thereof described in the specification, but do not preclude the possibility of the presence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

[0022] Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Terms defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and will not be interpreted in an idealized or overly formal sense unless explicitly defined herein.

[0023] In addition, when describing with reference to the attached drawings, identical components will be assigned the same reference numerals regardless of the drawing numbers, and redundant descriptions thereof will be omitted. When describing the present invention, if a detailed description of a related known technology is judged to unnecessarily obscure the gist of the present invention, the detailed description will be omitted.

[0024] The present invention relates to a test management system, which is a cloud-based software, that manages the process of requesting and conducting test services in the field of life sciences through a dedicated application.

[0025] FIG. 1 is a block diagram schematically illustrating the structure of a test management system according to one embodiment of the present invention.

[0026] Referring to FIG. 1, a test management system according to one embodiment of the present invention includes an administrator terminal (110), a CRO master terminal (120), a CRO terminal (130), a client terminal (140), and a server (200).

[0027] The administrator terminal (110) is a terminal used by administrators of a company that develops and provides dedicated applications. The administrator terminal (110) can be implemented in various ways as a terminal capable of communicating via wired or wireless communication networks. For example, the administrator terminal (110) can be implemented as a desktop computer, laptop computer, or other various devices.

[0028] The CRO master terminal (120) is a terminal used by managers, including team leaders and sales representatives, of the CRO (Contract Research Organization) company commissioned to perform the testing service. In one embodiment of the present invention, one or more CRO master terminals (120) may be implemented. For example, the CRO master terminal (120) may be implemented as a variety of devices, such as a desktop computer or laptop computer.

[0029] The CRO terminal (130) is a terminal used by personnel conducting tests at a CRO company. In one embodiment of the present invention, one or more CRO terminals (130) may be implemented. For example, the CRO terminal (130) may be implemented as various devices such as a desktop computer or laptop computer.

[0030] A client terminal (140) is a terminal used by a client company representative who has requested testing services from a CRO company. In one embodiment of the present invention, one or more client terminals (140) may be implemented. For example, the client terminal (140) may be implemented as a variety of devices, such as a desktop computer or laptop computer.

[0031] The server (200) provides a dedicated application to the administrator terminal (110), CRO master terminal (120), CRO terminal (130), and client terminal (140), provides various functions related to the test through the dedicated application, and provides a service function to share data and information in real time.

[0032] The server (200) can grant different permissions to the administrator terminal (110), CRO master terminal (120), CRO terminal (130), and client terminal (140) that log in through a dedicated application, and can provide different functions according to the permissions.

[0033] The server (200) provides a dashboard function that visualizes and displays information related to test management on the screen through a dedicated application.

[0034] In providing a dashboard function, the server (200) may provide an individual project dashboard function that displays information including the progress status and progress results for individual projects undergoing testing.

[0035] The server (200) can provide individual project dashboard functions to the administrator terminal (110), CRO master terminal (120), CRO terminal (130), and client terminal (140).

[0036] In providing a dashboard function, the server (200) can provide an overall project integrated management dashboard function that displays the progress and progress results of the entire project being tested.

[0037] The server (200) can provide the entire project integration management dashboard function only to the CRO master terminal (120).

[0038] The server (200) can create IDs of the CRO master, CRO, and client in the administrator terminal (110), input information of the CRO company and the client company, and provide functions for maintenance of the dedicated application.

[0039] The server (200) can input project information for testing into the CRO master terminal (120) to create a project, monitor the detailed progress of each project, and provide a chat function for chatting between one or more CRO terminals and one or more client terminals.

[0040] The server (200) can input information about a subcategory of a project into the CRO terminal (130), upload documents related to the project, and provide a chat function for chatting with one or more CRO master terminals and one or more client terminals.

[0041] The server (200) can monitor the progress of a project on a client terminal (140), download documents uploaded by a CRO terminal (130), and provide a chat function for chatting between one or more CRO master terminals and one or more CRO terminals.

[0042] In the present invention, the server (200) can grant different functions and permissions to the administrator terminal (110), CRO master terminal (120), CRO terminal (130), and client terminal (140) that log in to the dedicated application.

[0043] The server (200) can input information of the CRO company and the client company into the administrator terminal (110) used by the person in charge of the dedicated application production company that produces and manages the dedicated application, register and create an ID of each company's person in charge, check the login record, and grant the function and authority to record the maintenance history. At this time, the administrator terminal (110) is implemented so that it cannot view the contents created by the CRO master terminal (120) and the CRO terminal (130), and it cannot view all the contents of the test performed under contract between the CRO company and the client company and the chat contents.

[0044] Once a purchase agreement is signed between a CRO company and a dedicated application developer, a dedicated application is developed that reflects the CRO's feedback. The dedicated application developer then receives the CRO's client company information and requests and receives the names and email addresses of all CRO managers and CRO Masters involved in the testing process. Using the names and email addresses provided, the dedicated application developer creates IDs for the CRO managers and CRO Masters and automatically sends invitation emails to those addresses. The recipients then create a password to gain login access and complete registration.

[0045] Once a test outsourcing contract is concluded between a CRO company and a client company, the CRO company requests the dedicated application developer to create an ID for the client. The administrator then enters the client's company information and creates an ID using the client's email address. Simultaneously, an invitation email is automatically sent to the client's email address. The client receives the email and creates a password to gain login privileges and complete registration. In other words, the administrator creates an ID and grants the user the ability to use it. The client then receives an email from the administrator and sets only a password. In other words, only the user (client) has access to the password.

[0046]

[0047] Figures 2 to 53 are examples of dedicated application screens (UI / UX) provided by a test management system according to one embodiment of the present invention.

[0048] Figure 2 is an example of a login screen for a dedicated application.

[0049] When logging in to the administrator (Admin) terminal (110) in Fig. 2, you can enter the administrator ID and password, and if the administrator ID and password set to have administrator authority are entered, you are logged in as an administrator.

[0050] Figures 3 to 13 are examples of dedicated application screens (UI / UX) provided to an administrator terminal in a test management system according to one embodiment of the present invention.

[0051] Figure 3 is an example of a dedicated application screen provided to the administrator terminal (110), with a menu displayed on the left side of the screen. When "All Users" is selected from the menu, a list is displayed for managing all users, including the CRO master (CRO_MASTER), CRO, and clients. This list provides the ability to edit or delete information for each user. In this way, the present invention displays all users as a list, allowing for quick identification.

[0052] FIG. 4 is an example screen when the 'Client Companies' menu is selected in the example screen of FIG. 3, and displays a list of client companies, providing functions for entering, modifying, and deleting client company information. The screen of FIG. 4 has an 'Add Client Company' button at the top right, and when this button is selected, a screen is provided for entering information on a new client company and adding it to the list, as shown in FIG. 5.

[0053] Figure 6 is an example screen when the 'CRO Companies' menu is selected. It displays a list of CRO companies, which are test performing organizations, and provides functions for entering, modifying, and deleting CRO company information. The screen in Figure 6 has an 'Add CRO Company' button in the upper right corner. When this button is selected, a screen is provided for entering information on a new CRO company and adding it to the list, as shown in Figure 7.

[0054] Figure 8 is an example screen when the 'Client Registration' menu is selected, and provides functions for entering information to create a Client ID, confirming the ID, and sending an email invitation to create a password (PW).

[0055] When all input items in Figure 8 are entered and the 'Enter' button is selected, an invitation is sent to the corresponding email address, as shown in Figure 9. Furthermore, when the 'Sign Up' button is selected in the email content, an input window for setting a password to be used for the corresponding ID account is provided.

[0056] Figure 10 is an example screen when the 'CRO Registration' menu is selected, and provides functions for entering information for creating a CRO ID, confirming the ID, and sending an email invitation for password (PW) generation. As with the client membership registration screens in Figures 8 and 9, in the case of CRO membership registration, an email for password registration is sent to the email address entered in Figure 10. Once the password is registered via email, the ID and password are registered, and membership registration is completed.

[0057] Fig. 11 is an example screen when the 'CRO Master Registration' menu is selected, and provides functions for entering information to create a CRO Master ID, confirming the ID, and sending an email invitation for password (PW) generation. As with the client membership registration screens in Figs. 8 and 9, in the case of CRO Master membership registration, an email for password registration is sent to the email address entered in Fig. 11, and when the password is registered via email, the ID and password are registered and membership registration is completed.

[0058] Figure 12 is an example screen when the 'Activity History' menu is selected, and provides a function to manage activity history for maintenance.

[0059] Figure 13 is an example screen when the 'Maintenance Report' menu is selected, and provides a function to input event and resolution information for maintenance history management and manage it in report format.

[0060]

[0061] Figures 14 to 31 are examples of dedicated application screens (UI / UX) provided to a CRO master terminal in a test management system according to one embodiment of the present invention.

[0062] When logging in to the CRO master terminal (120) in FIG. 2, the CRO master ID and password can be entered, and when the CRO master ID and password set to have CRO master authority are entered, the user is logged in as the CRO master.

[0063] Figure 14 is an example of a dedicated application screen provided to the CRO master terminal (120) when logged in as a CRO master. A menu is displayed on the left side of the screen. Selecting "All Users" from the menu provides the ability to view and manage all CRO masters, CRO IDs, and contact information belonging to the same CRO company. For example, editing and deleting functions can be provided due to changes in team members.

[0064] Figure 15 is an example screen where the 'Client & Project Status' menu is selected, displaying a list of client information entered by the administrator terminal (110). When the '>' mark on the far right of this screen is selected, a list of project information contracted by the client is provided, as shown in Figure 16.

[0065] In Fig. 16, the function for entering project information and checking the project list is provided, and when the '>' mark on the far right is selected, the detailed information of the corresponding project is displayed and provided. In other words, when a project contract for a corresponding client is created in the client list of Fig. 15, the function for entering the corresponding project information is provided in the screen example of Fig. 16. When the 'Add Project' button in the upper right of Fig. 16 is selected, the function for entering and creating new project information is provided, as shown in Fig. 17.

[0066] When the 'Add Project' button, which is a project creation button in the screen example of Fig. 18, is selected, a screen is provided where a project contracted with a client can be created and a person in charge of the project can be designated, as shown in Fig. 19.

[0067] In Figure 19, we provide the ability to select a project manager, where you can designate a project manager, and only the designated project manager can write test results and upload documents for that project.

[0068] Figures 20 to 26 are examples of project details screens.

[0069] As shown in FIGS. 20 to 26, in the screen examples where the 'Client & Project Status' menu is selected, when a project is selected from the project list and the '>' button is selected, a detailed screen for the corresponding project is provided. These project details are created on the CRO terminal (130). In addition, monitoring can be performed using a viewer on the CRO master terminal (120).

[0070] Fig. 20 is an example screen showing a case where the 'Test Article' tab is selected in the project details, Fig. 21 is an example screen showing a case where the 'Test & Progress' tab is selected in the project details, and the contents and progress related to the test are displayed, and Fig. 22 is an example screen showing a case where the 'Equipment & Material' tab is selected in the project details.

[0071] Figure 23 is an example screen showing a case where the 'Test Method' tab is selected in the project details, and Figure 24 is an example screen showing a case where the 'Test Results' tab is selected in the project details.

[0072] Figure 25 is an example screen showing a case where the 'Project Team' tab is selected in the project details, and Figure 26 is an example screen showing a case where the 'Documents' tab is selected in the project details.

[0073] Figure 27 is an example screen when the "Activity Report" menu is selected, illustrating a dashboard-style screen. This menu allows the user to reconfigure the screen to suit the specific circumstances of the CRO company.

[0074] In Figure 27, Total Project indicates the total number of projects performed for a specific client, Project Completion Status indicates the number of projects in progress or completed, Project Completion Time indicates the number of days required from contract to project completion, and Contract Number for Each Description indicates the number of contracts for the provided test items.

[0075] Figure 28 is an example screen when the 'History' menu is selected, and provides a function to display the login history of the CRO managers (CRO masters and members with CRO IDs) and clients.

[0076] Figure 29 is an example screen when the "Test Preparation List" menu is selected, providing a function for entering a list of all tests being conducted by the CRO company. Providing this menu function facilitates the extraction of values ​​for each test from the dashboard, and contributes to convenience by eliminating the need to enter the experiment name each time test content is entered on the CRO terminal (130).

[0077] In Figure 29, the Name of Test Description field indicates the provided test item, the Date of Set-up field indicates the test setting completion date, the Application field indicates the scope to which the set test can be applied, the Responsible Person / Team field indicates the person in charge's name or team name, and the Note of Last Update field indicates an update to the latest revision.

[0078] Figure 30 is an example screen when the 'Chat' menu is selected, and illustrates a chat menu that provides a chat function.

[0079] In the example of Fig. 30, a client list with client information is displayed, and when a client with whom a chat is desired is selected and the '>' button on the far right is selected, a chat function is provided that allows chatting as shown in Fig. 31. At this time, a chat function for multiple chats, such as CROs, CRO masters, and clients of the same CRO company, can be provided.

[0080]

[0081] Figures 32 to 51 are examples of dedicated application screens (UI / UX) provided to a CRO terminal in a test management system according to one embodiment of the present invention.

[0082] When logging in to the CRO terminal (130) in Fig. 2, a screen is provided where a CRO ID and password can be entered, and when a CRO ID and password set to have CRO authority are entered, the user is logged in to CRO.

[0083] Fig. 32 is an example of a dedicated application screen provided to a CRO terminal (130) when logged in as a CRO, with a menu displayed on the left side of the screen. When 'Client & Project Status' is selected from the menu, a list of clients managed by the CRO and a list of projects managed by the CRO are displayed. Here, when the '>' button on the right is selected, a list of projects for which the CRO is designated as the project manager is displayed, as shown in Fig. 33. In addition, when the '>' button on the right is selected, a screen for entering detailed information about the project is provided, as shown in Fig. 34. At this time, the project information is the information entered by the CRO Master when creating the project. Fig. 34 displays a list of projects for all clients contracted with the CRO company, but when the '>' button is selected, only the projects managed by the CRO are displayed. That is, when the '>' button is selected, a list of projects managed by the CRO is displayed, and detailed information about a project selected from among them is provided.

[0084] Figure 34 is an example screen showing the "Test Article" tab selected on the project details screen, displaying a list of test article information. When the "Add Test Article" button on the right is selected, a screen for entering test article information is provided, as shown in Figure 35.

[0085] In Figure 34, the Test Articles item refers to test specimens that cause cell processing, animal administration, or chemical reactions.

[0086] The "Necessary" section indicates the necessary sample materials for conducting the contracted test. Since the test design must be agreed upon between the test client and the test performer after the test contract is signed, the required sample volume for the test is calculated in advance. Based on this calculated volume, an agreed-upon safety factor is assigned, and the number of sample vials and concentrations to be provided is determined.

[0087] The Recombinant Gene section indicates whether genetic recombination is necessary when the test substance is a virus or cell containing genetic material, or genetic material such as DNA or RNA. Among these, genetically modified organisms (LMOs: Living Modified Organisms) can cause environmental problems or affect the human body, so it is important to record and safely manage them. When conducting experiments using LMOs, facilities must report or obtain approval according to the safety management level. LMOs that pose a high risk to humans or the environment require re-approval.

[0088] The Biosafety Level (BSL) category indicates the biological safety level. BSL (Biological Safety Level) levels range from 1 to 4, categorizing necessary facilities and equipment based on the level of hazard posed by infectious organisms. These levels are based on the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC). Each BSL level requires compliance with laboratory practices, safety equipment, and facility construction requirements.

[0089] The Conc. [mg / mL] field indicates the concentration of the sample. Samples must be received at a concentration higher than the highest concentration at the time of sample administration; concentrations lower than that can be diluted and processed.

[0090] The Volume [mL / vial] item indicates the volume per vial of the sample.

[0091] The Received [Vials] field indicates the number of vials received. For samples with a high risk of human or animal infection or risk, accurate records of the number of vials received, the number of vials used, and the number of natural vials are essential for management. The present invention provides a field for recording these numbers.

[0092] The Used [Vials] item indicates the number of vials used.

[0093] The Label Number item indicates the notation on the label, and can be used to check the product number and lot number.

[0094] The Storage Condition section indicates the specimen storage environment. After specimen delivery, the pre-agreed storage conditions must be adhered to until testing. Failure to comply with these conditions will reduce the reliability of test results and their validity.

[0095] Figure 36 illustrates the screen when the "Test & Progress" tab is selected in the project details screen, displaying test-related information and progress. This allows for a quick overview of test progress, reducing the need for emails, phone calls, and other communications. Furthermore, given the nature of the biopharmaceutical industry, cell and animal testing often requires lengthy observations and measurements. This feature can help CROs and clients avoid neglecting their work during these extended periods. Selecting the "Add Test" button on the right provides a screen where users can enter test details, progress, test methods, and test results, as shown in Figure 37.

[0096] In Figure 36, the Test Description item represents a list of test items contracted between the test requester and the test performer.

[0097] The Test Article Arrival Date field indicates the date the test specimen was received, the Test Start Date field indicates the test start date, and the Test Completion Date field indicates the test completion date.

[0098] The Preliminary Report Issued Date field indicates the date the preliminary report was issued, the Customer Feedback Receipt Date field indicates the date the customer requesting the test received feedback on the draft report, and the Final Report Issued Date field indicates the date the final report was issued.

[0099] The Progress item is a value set according to the importance of the task through agreement between the CRO company and the client company, and the progress is expressed in 10% increments.

[0100] The Testing Status field indicates whether the contract is in progress or has been finalized.

[0101] Figure 38 is an example screen showing the case where the 'Equipment & Material' tab is selected in the project details screen, and provides a function that allows information on equipment used in the test to be displayed and entered.

[0102] In Figure 38, under 'Cell', the Cell line item represents a cell line. Cell lines refer to individual cells with identical genetic information, and are primarily used in bioprocesses for mass production. They possess immortal properties, allowing for long-term cultivation, making mass cultivation easy.

[0103] The Strain entry represents a cell line. Cell lines are derived from cell lines, have a finite lifespan, and have a limited number of divisions, making them preferred for vaccine development.

[0104] The Source item indicates the tissue from which the material originated, such as human, animal, or stem cell.

[0105] The Culture entry indicates the name or composition of the medium in which the cells are cultured.

[0106] The Primary Passage No. entry indicates the number of passages the cells have been through since they were isolated from the tissue until they became stable.

[0107] The Subculture No. field indicates the number of subcultures performed before the stored cells were removed and stabilized for testing. Because mutations can occur if the number of subcultures exceeds a certain threshold, the maximum number of subcultures allowed for a specific cell type can be determined in advance.

[0108] The Cell Density [cells / flask] item indicates the amount of cells in one culture flask, and accurate test results can be obtained when an appropriate amount of cells are distributed in the flask.

[0109] The Culture Condition [Temp. & Air] item indicates the temperature and gas composition conditions inside the incubator.

[0110] In Figure 38, in 'Animal', the Animal item indicates the name of the animal.

[0111] The Species entry represents animal species, which are scientifically classified and named based on their genetic makeup and characteristics.

[0112] Strain is a sub-concept of animal species and refers to something developed through inbreeding, genetic modification, or selective breeding.

[0113] The Source field indicates the source of the test animals, whether they were sourced from a commercial supplier, an institutional animal facility, or the wild.

[0114] The Age column indicates the age of the test animal, and the Weight column indicates its weight. This column allows you to verify that the weight is within the standard range and, based on this, determine whether the animal's weight changed during the test period.

[0115] The Number of Female entry indicates the number of female test animals.

[0116] The Pregnancy Status field indicates whether the female animal is pregnant. Pregnancy can cause changes in the body and behavior, and alter response mechanisms when administering medications, which can affect results.

[0117] The Number of Male item indicates the number of male test animals, and the Health Status item indicates the health status of the test animals.

[0118] The Acclimatization [Days] item indicates the animal acclimatization period, which means the period of time after the animal is admitted to the test site for stabilization.

[0119] The Housing and Care Condition section indicates the living environment of the test animals.

[0120] The information listed under "Equipment" in Figure 38 can be used to verify whether equipment calibration and inspection were performed periodically as needed, and whether there were any issues with the equipment. Furthermore, "Equipment" indicates that appropriate equipment was used, thereby maintaining test reliability.

[0121] In Figure 38, under 'Equipment', the Product Name field indicates the equipment name, the Supplier field indicates the equipment provider, the Product No. field indicates the product number, and the Lot No. field indicates the lot number.

[0122] By checking the information on reagents and consumables used in the 'Laboratory Reagents and Consumables' section in Figure 38, you can determine whether products of an appropriate level for use in the test were used.

[0123] In the 'Laboratory Reagents and Consumables' section of Figure 38, the Product Name section indicates the product name, the Supplier section indicates the supplier name, the Product No. section indicates the product number, and the Lot No. section indicates the lot number.

[0124] When the 'Add Cell' button is selected in Figure 38, a screen is provided where cell information used in the test can be entered, as shown in Figure 39.

[0125] And, when the 'Add Animal' button is selected in Fig. 38, a screen is provided where information on the animal used in the test can be entered, as shown in Fig. 40.

[0126] And, when the 'Add Equipment' button is selected in Fig. 38, a screen is provided where information on the equipment (machine) used in the test can be entered, as shown in Fig. 41.

[0127] And, when the 'Add Reagents and Consumables' button is selected in Fig. 38, a screen is provided where information on reagents and consumables used in the test can be entered, as shown in Fig. 42.

[0128] In this way, the present invention allows for a dual check of suitability by both the client and the CRO by verifying detailed information about the test organism cells and animals, such as cell line, strain, and species. Furthermore, information on the equipment used can be verified, and maintenance documents matching the lot number can be quickly confirmed in the attached document. Furthermore, detailed information can be provided to emphasize transparency regarding the materials used. Furthermore, the product number can be used to confirm whether the appropriate grade of reagent for cell administration and animal administration was used. For example, if only the reagent name is described, it is difficult to determine the grade information.

[0129] Figure 43 is an example screen showing a case where the 'Test Method' tab is selected in the project details screen, and provides information about the test method. That is, the information entered in the 'Test & Progress' tab is uploaded and displayed, and the function to edit the information is provided here. In this way, the present invention provides a function to clearly present guidelines for the test method. For example, it is possible to determine whether the guidelines are suitable for the purpose of obtaining IND approval, and in the case of tests dealing with living organisms such as cells and animals, some reproducibility errors may occur, and it is possible to check how many times the test was repeated, and it is possible to check how many flasks were used in the same repetition in one batch experiment, and how many batch experiments (duplicate, triplicate) were performed.

[0130] In Figure 43, in Test Method (Cell), the Cell line item indicates the cell line name. This item can contain the cell line name or cell lineage, as cell lineage is sometimes considered part of a cell line.

[0131] The Test Method entry indicates the test method.

[0132] The Practice Guideline item indicates whether the standards of the regulatory agency have been followed, and this item can be used to determine the reliability of the test method and the reproducibility of the test.

[0133] The Cell Density [cells / flask] entry indicates the amount of cells in the test flask.

[0134] The Flask Number field indicates the number of test flasks. This field indicates how many identical repeats were performed in one batch of tests.

[0135] In the Treated TA Conc. [mg / mL] entry, TA stands for Test Article and indicates the concentration of the sample at the time of treatment.

[0136] The Treated TA Amount [mL / flask] entry indicates the amount of test sample treated in the flask.

[0137] The Experimental Replication item indicates the number of test repetitions, which can be used to check reproducibility.

[0138] In Test Method (Animal) in Figure 43, the Animal item indicates the animal, the Test Method item indicates the test method, the Practice Guideline item indicates whether the standards of the regulatory agency were followed, the Number of Animal item indicates the number of animals used in the test, the Treated TA Conc. [mg / mL] item indicates the concentration of the treated sample (TA: Test Article), and the Treated TA Amount [mL / animal] item indicates the volume of the treated sample.

[0139] In Test Method (Chemical) in Figure 43, the Chemical Reaction item indicates the name of the chemical reaction used to derive the test result, and the Test Method item indicates the test method.

[0140] The Quvette Number field indicates the number of cuvettes (containers in which chemical reactions occur and which have specifications for measuring absorbance). This field indicates how many replicates of the same treatment were performed in one batch.

[0141] Treated TA Conc. [mg / mL] indicates the concentration of the treated sample, Treated TA Amount [mL / animal] indicates the amount of the treated sample, and Treated Reagent Conc. [mg or Mm / Quvette] indicates the concentration of the treated reagent per cuvette.

[0142] The Experimental Replication item indicates the number of repetitions of the test, which can be used to check reproducibility.

[0143] Figure 44 is an example screen showing the case where the 'Test Results' tab is selected in the project details screen, and is a screen that displays the contents of the experimental results. In other words, the information entered in the 'Test & Progress' tab is uploaded and displayed, and the function to modify the information and enter the test results is provided here. In bioprocesses, the material produced in the upstream (cultivation process) is generally subjected to impurity removal in the downstream (purification process). The Ministry of Food and Drug Safety recommends or sets standards for how much of the impurities in the final product are removed to maintain quality. In the present invention, it is possible to check at a glance whether this is a pass / fail. At this time, the standard can be set by the laboratory for research purposes, or it can be set more strictly than the Ministry of Food and Drug Safety's recommendation.

[0144] In Figure 44, the Test Description item is the test item name, and the Test Result item indicates the test result.

[0145] The Criteria section describes the standards set by the client in advance. These can be set by the client that requested the test, or they can follow the non-clinical test standards set by the regulatory agency.

[0146] The Status item indicates whether the criteria are met, and the Completed[Y / N] item indicates whether the test has been completed.

[0147] Figure 45 is an example screen showing a case where the 'Project Team' tab is selected on the project details screen. It provides a screen where client company information can be displayed and modified as a list, and information including the positions, roles, and mobile phone numbers of project team personnel can be displayed and modified as a list.

[0148] In Figure 45, in 'Client Company', the Company Name field indicates the client company name, the Address field indicates the client office address, the Homepage field indicates the homepage address where client information can be found, and the Business Type field indicates the type or business area of ​​the client company's developed product.

[0149] In the 'Project Team' in Figure 45, the Name field indicates the name of the person in charge, the Position field indicates the position / rank, the Role field indicates the role, and the Phone No. field indicates the phone contact information.

[0150] Figure 46 is an example screen that provides a function for editing information of a project team related person in the example screen of Figure 45.

[0151] Figure 47 is an example screen showing a case where the 'Documents' tab is selected in the project details screen, and provides a screen for uploading data or document files. Here, when the 'Add Mandatory Document' button is selected, the function for uploading mandatory documents is provided, as shown in Figure 48, and when the 'Add Supplementary Document' button is selected, the function for uploading supplementary documents is provided, as shown in Figure 49.

[0152] In Figure 47, the Document Name item in the 'Mandatory Document' field indicates the name of the document that was to be provided in advance at the time of contract, and the Description item indicates a description of the document.

[0153] In Figure 47, the Document Name item in 'Supplementary Documents' indicates other documents other than the document to be provided, and the Description item indicates a description of the document.

[0154] Figure 50 illustrates a screen example where the "Dashboard" tab is selected on the project details screen, providing a dashboard screen. This screen example illustrates a dashboard that displays progress analysis, test completion times, and other data as bar graphs. However, this is not a limitation; dashboards can be provided in various formats and configurations.

[0155] In Figure 50, Total Test indicates the number of tests performed, Progress Analysis indicates the progress of the test, Test Completion Time indicates the period of time from receipt of the sample to completion of the test, Summarized Results indicates the number of tests that met the criteria, and Completion Status by Test Description indicates the number of completed tests.

[0156] Figure 51 is an example screen when the 'Chat' menu is selected, and illustrates a chat menu that provides a chat function.

[0157] In the example of Figure 51, a client list with client information is displayed, and when a client with whom a chat is desired is selected and the '>' button on the far right is selected, a chat function is provided for chatting, as shown in Figure 52. At this time, a chat function for multiple chats, such as CROs, CRO Masters, and clients of the same CRO company, can be provided.

[0158]

[0159] Figures 52 and 53 are examples of dedicated application screens (UI / UX) provided to a client terminal in a test management system according to one embodiment of the present invention.

[0160] When logging in to a client terminal (140) in FIG. 2, a screen is provided for entering a client ID and password, and when a client ID and password set to have client authority are entered, the client is logged in.

[0161] Figure 53 shows an example screen that provides a function to display a list of projects of a client in the 'Project Status' menu when logged in as a client, and to display detailed information about a project when a project to be checked is selected from the project list.

[0162] Additionally, in the case of the client terminal (140), as with the CRO master terminal (120) and CRO terminal (130) described above, a 'Chat' menu is provided that provides a chat function that allows multiple-to-multiple chatting.

[0163]

[0164] Figures 54 to 63 are examples of dashboard screens in a dedicated application provided by a test management system according to one embodiment of the present invention.

[0165] Figure 54 is an example screen with the dashboard tab selected, showing an individual project dashboard that displays information including progress and progress results for individual projects.

[0166] Referring to Figure 54, the total number of tests (Total Tests), progress analysis of tests, time from specimen receipt to test completion (Test Completion Time), number of criteria met (Summarized Results), and number of tests completed by test item (Completion Status by Test Description) are displayed in various visual graphs on the individual project dashboard.

[0167] Figure 55 is an example of a dashboard-type screen provided in the "Activity Report" menu of the CRO master terminal (120), showing an overall project integrated management dashboard that displays the progress and progress results for the entire project undergoing testing.

[0168] Referring to Figure 55, the total number of projects (Total Project), the number of projects completed or in progress (Project Completion Status), the number of days from project contract to completion (Project Completion Time), and the number of contracts for each test item (Contract Number for Each Description) are displayed in various graphs in visual form on the overall project integrated management dashboard.

[0169] In the present invention, when providing a dashboard function in the server (200), the dashboard can be provided based on or linked to input data. For example, in FIG. 20, a dashboard screen can be provided based on data entered for each project item. Alternatively, in FIG. 37, when entering data for each contract, the start date and the final completion date (report issuance date) are entered, and since the person in charge information is also entered at this time, the time required for each test item or project can be known, and the work required for each person in charge can also be confirmed. In this way, the server can extract information from the entered data and provide a dashboard.

[0170] The present invention can manage team resources by identifying the speed and amount of work of individual employees, checking whether a specific employee is a bottleneck, distributing work appropriately, and rewarding employees who achieve outstanding performance.

[0171]

[0172] Figure 56 is an example of a dashboard screen displaying test result analysis information.

[0173] Figure 56 illustrates a dashboard that displays a graph analyzing the pass / fail results of project tests, a chart summarizing test results for each project, and a graph showing the percentage of institutions providing baseline guidelines. For example, if a client requests a test expecting a pass (PASS) result, the dashboard can be used to identify the cause of a high frequency of failures.

[0174] The graph of percentage of institutions providing guidelines for setting benchmarks shows the percentage of test items provided that do not follow the guidelines of a certain regulatory agency.

[0175] Figure 57 is an example of a dashboard screen that displays the time required.

[0176] Figure 57 illustrates a dashboard that displays the number of days required for each contract test item, the total number of days required for the project, and the average number of days required for each test item as a bar graph. This dashboard allows users to identify patterns in time requirements, view the data to identify discrepancies between estimated and actual times, and identify the cause of any significant discrepancies. Furthermore, based on this data, clients can be informed of the estimated time requirements for each test item before signing a contract.

[0177] Figure 58 is an example of a dashboard screen displaying schedule management.

[0178] An example dashboard is shown in Figure 58 showing confirmation of specimen receipt and transmission, progress of performance of contract test items, and graphs of the number and percentage of completed test items under the contract.

[0179] The sample receipt and transmission confirmation graph displays the percentages of pre-transmission, in-transit, and completed receipts. The progress of contracted test items is displayed as a bar graph. Furthermore, the number and percentage of completed tests within the contract graph displays the ratio of ongoing and completed tests.

[0180] Figure 59 is an example of a dashboard screen displaying sales strategies.

[0181] Figure 59 illustrates a dashboard that displays bar graphs showing the total number of contracts by test item, the total number of contracts by company, and the number of contracts for specific test items by quarter. This dashboard can be used to develop customer management and sales strategies.

[0182] Figure 60 is an example of a dashboard screen displaying team resource management.

[0183] Figure 60 illustrates a dashboard that displays bar graphs showing the number of projects performed by each CRO, the number of clients assigned to each CRO, and the cumulative annual work performed by each CRO. This dashboard allows you to assess whether work is well distributed across team resources and whether bottlenecks have occurred.

[0184] Figure 61 is an example of a dashboard screen displaying sample analysis of a water order test.

[0185] Figure 61 displays the status of project orders categorized by treatment type as a bar graph. The development stage of ordered test samples is also displayed as a graph, indicating the ratio of drug discovery to preclinical testing. Furthermore, the status of sample storage locations is also displayed as a bar graph. This dashboard allows users to understand the status of laboratory storage through sample analysis.

[0186] Figure 62 is an example of a dashboard screen displaying procurement and instrument management.

[0187] Figure 62 illustrates a dashboard that displays bar graphs showing the average lead time for each major supplier, the status of laboratory equipment calibration, and the number of equipment and supplies for each person responsible. This dashboard allows for the management of equipment and supplies, and by monitoring procurement status, for supply chain management.

[0188] Figure 63 is an example of a dashboard screen displaying test quality management.

[0189] Figure 63 illustrates a dashboard showing the blank histogram distribution of a specific test item, negative and positive controls for a specific test item, and the between-test replicate variability as bar graphs.

[0190] Since the blank value (background value), negative control, and positive control are measured every time a test is performed regardless of the type of sample, the consistency and reliability of the provided testing service can be determined through the deviation of these values, which in turn indicates the quality of the provided service.

[0191] The dashboard provided by the present invention can be used to determine the cause of high control group deviations for each experimental case. For example, it may be necessary to determine whether there is a problem with the test execution method of a specific experimenter.

[0192] In this way, by automatically changing the graph within the dashboard according to the input value at the same time as data is input in the present invention, real-time test management is possible through the dashboard, and quick management decisions can be made.

[0193] Furthermore, the present invention utilizes a dashboard to analyze reagent and consumable lead times (arrival date - order date) to evaluate vendors and determine whether to continue transactions. Supply chain analysis can also be used to predict expected experimental schedules. Furthermore, by organically incorporating supply chain management results into work schedule management and viewing them as mutually impactful, meaningful results can be derived from individual items.

[0194] The present invention may provide a function to automatically send an email or text message to a person in charge when the time comes to record the date of calibration or validation for a management device or apparatus and perform it periodically.

[0195] Even though the samples vary for each contract, most tests require measuring blank or control values ​​each time according to established testing methods. The present invention identifies deviations between these values, thereby verifying the consistency and reliability of each test item, i.e., the services provided by the CRO company.

[0196]

[0197] While the present invention has been described using several preferred embodiments, these embodiments are illustrative and not limiting. Those skilled in the art will appreciate that various changes and modifications can be made without departing from the spirit and scope of the invention as set forth in the appended claims.

Claims

1. In the test management system that manages the process of requesting and conducting test services in the field of life sciences through a dedicated application, Administrator terminal, which is a terminal used by the administrator of a company that produces and provides the above-mentioned dedicated application; CRO master terminal, a terminal used by managers including team leaders and sales representatives of the CRO company that has been commissioned to perform testing services; CRO terminal, a terminal used by a person in charge of conducting tests at the above CRO company; A client terminal used by a customer representative who has requested a test service from the above CRO company; and A server that provides the dedicated application to the above administrator terminal, the CRO master terminal, the CRO terminal, and the client terminal, provides various functions related to the test through the dedicated application, and shares data and information in real time. Test management system including.

2. In claim 1, A test management system characterized in that the server grants different permissions to the administrator terminal, the CRO master terminal, the CRO terminal, and the client terminal that log in through the dedicated application, and provides different functions according to the permissions.

3. In claim 2, A test management system characterized in that the above server generates IDs of a CRO master, CRO, and client in the above administrator terminal, inputs information of a CRO company and a client company, and provides a function for maintenance of the above dedicated application.

4. In claim 3, A test management system characterized in that the server inputs project information for conducting a test into the CRO master terminal to create a project, monitors the detailed progress of each project, and provides a chat function between one or more CRO terminals and one or more client terminals.

5. In claim 4, A test management system characterized in that the server inputs information about a subcategory of a project into the CRO terminal, uploads documents related to the project, and provides a chat function between one or more CRO master terminals and one or more client terminals.

6. In claim 5, A test management system characterized in that the server monitors the progress of a project on the client terminal, downloads documents uploaded by the CRO terminal, and provides a chat function between one or more CRO master terminals and one or more CRO terminals.

7. In claim 2, A test management system characterized in that the above server provides a dashboard function that visualizes and displays information related to test management on a screen through the above dedicated application.

8. In claim 7, A test management system characterized in that the server provides an individual project dashboard function that displays information including progress and progress results for individual projects undergoing testing, in providing the dashboard function.

9. In claim 8, A test management system characterized in that the server provides the individual project dashboard function to all of the administrator terminal, the CRO master terminal, the CRO terminal, and the client terminal.

10. In claim 7, A test management system characterized in that the server provides a full project integrated management dashboard function that displays the progress and progress results of the entire project in which the test is being conducted in an integrated manner, in providing the dashboard function.

11. In claim 10, A test management system characterized in that the above server provides the overall project integrated management dashboard function only to the CRO master terminal.

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