KR102052066B1 - Remote CRO system and method using block-chain - Google Patents

Abstract

The present invention relates to a remote CRO system using a blockchain and a method thereof. More particularly, the present invention relates to a remote CRO system using a blockchain which concludes a smart contract between a client server (200), a researcher server (300), and a CRA server (400) through a CRO providing server (100) based on the blockchain technology, shares and manages information about the progress of a specific clinical trial, and applies a tracking function for addition, modification and deletion to prevent forgery and alteration, and a method thereof.

Description

Remote CRO system and method using block chain {Remote CRO system and method using block-chain}

The present invention relates to a remote CRO system using the blockchain and a method thereof, and more particularly, by adopting blockchain technology to apply the smart contract and data transparency of the blockchain to the remote CRO platform, each institution involved in clinical trials Remote CROs using blockchain to sign smart contracts to improve transparency, reliability and security of cross-party project unit (specific clinical trials) data for all phases of the trial A system and method thereof are provided.

The Korean pharmaceutical market is currently conducting evidence-based clinical studies on many products and attempting to increase the brand's value through the results. It exists.

In addition, clinical trials of many products currently on the market generally include post-marketing investigations (PMS), researcher-led clinical trials (IIT), and pharmaceutical-led clinical trials (SIT). Various clinical trials, especially phase 4 studies, are difficult to proceed with clinical research that can be conducted in primary medical institutions.

When a pharmaceutical company develops a new drug through the CRO (Contract Research Organization), that is, a clinical trial consignment agency, it entrusts clinical trial work with a separate contract to reduce the cost of clinical trials and facilitate the conduct of clinical trials. Through the company, he is conducting clinical trial work.

However, in case of such CRO, there are problems such as delay in research due to change of staff in long-term research due to high turnover rate of CRA (Clinical Research Associates) who conduct clinical trial work and increase of research cost. For this reason, there is a problem that there are many spatial and temporal constraints due to the necessary expertise for research and document work and storage.

In addition, these clinical trials have many tasks that require trust between institutions, and the protection of personal information and clinical trial data is an essential element, which requires a lot of cost and time.

In other words, due to the interests of each institution in clinical research, it is difficult to open and share databases with each other, and even if the database is shared, data may be altered or security incidents may occur. It is also a problem of wrong or wrong.

Accordingly, the remote CRO system and method using the blockchain according to an embodiment of the present invention, in order to solve the above-mentioned problems, by quickly / accurately processing all the tasks of the various CRO through one cloud platform, In addition to maximizing economic and time efficiency, blockchain technology can be used to enhance data security and relationships.

In this regard, Korean Laid-Open Patent Publication No. 10-2010-0133663 ("Electronic Case Record Sheet Generating Apparatus and Method") allows the clinical investigator to easily and quickly generate various electronic case record sheets to be used by using metadata. Therefore, a device that can significantly shorten the design period of clinical trials is disclosed.

Domestic Patent Publication No. 10-2010-0133663 (published 2010.12.22.)

The present invention has been made to solve the problems of the prior art as described above, the object of the present invention is to introduce a blockchain technology to conclude a smart contract (smart contract) for each institution involved in the clinical trials of clinical trials It is to provide a remote CRO system and a method using a blockchain that can improve the transparency, reliability and security of the data between the project units (specific clinical trials) data between all parties (process).

The remote CRO system using a blockchain according to an embodiment of the present invention receives the request information of a specific clinical trial including a desired clinical plan from the outside, and matches the specific clinical trial among the pre-stored researcher groups. By setting a specific researcher group, the CRO providing server 100 for delivering the progress request information of the specific clinical trial to the set specific researcher group, connected to the CRO providing server 100, the progress of the desired specific clinical trial The client server 200 receives the request information and delivers the information to the CRO providing server 100, and is connected to the CRO providing server 100 to receive the request information of the specific clinical trial, and according to the specific clinical trial. The researcher server 300 and the C requesting the progress of the work, receiving the clinical trial data generated according to the work progress and delivering to the CRO providing server 100 The specific clinical trial is progressed by using the request information of the specific clinical trial received from the client server 200 and the clinical trial data received from the researcher server 300 connected to the RO providing server 100. It generates a real-time information in real time, and includes a CRA server 400 for managing the work progress of the specific clinical trial according to the progress information, the CRO providing server 100 is the specific of the client server 200 Prior to the progress of the task according to the specific clinical trial in the researcher server 300 according to the clinical trial progress request information,

Based on the blockchain technology, a smart contract between the client server 200, the researcher server 300, and the CRA server 400 is concluded to obtain information related to the progress of the specific clinical trial. It is preferable to further include a blockchain management module 110 to manage the sharing between.

Furthermore, the CRA server 400 generates a customized CRF (Case Report Form) for the specific clinical trial and provides the CRO based on the progress request information of the specific clinical trial received from the client server 200. Delivering to the server 100, the researcher server 300 receives the customized CRF generated by the CRA server 400, the clinical trial data generated in accordance with the progress of the work according to the specific clinical trial said It is desirable to enter in a custom CRF.

Furthermore, the CRA server 400 preferably stores and shares the clinical trial data received from the researcher server 300 by converting the clinical trial data received from the researcher server 300 into an e-CRF (electronic CRF).

Furthermore, the remote CRO system utilizing the blockchain further includes a security server 500 connected with the CRO providing server 100, and the client server 200, the researcher server 300 and the CRA server 400 ) Is connected to the CRO providing server 100 via the security server 500, the security server 500 is the CRO providing server 100, the client server 200, the researcher server according to a predetermined security policy It is preferable to perform security of information transmitted and received between the 300 and the CRA server 400.

Furthermore, the CRA server 400 performs management of the progress of the specific clinical trial, and statistics the clinical trial data received from the researcher server 300 through an analysis system of pre-stored clinical trial data. While analyzing, it is preferable to store and manage the clinical trial data and the statistical analysis result data according to each specific clinical trial by database.

Furthermore, the CRO providing server 100 is a database for each specific clinical trial of the information related to the progress of the specific clinical trial generated and received from the imaginary client server 200, the researcher server 300 and the CRA server 400 To store and manage,

Through the blockchain management module 110, by the smart contract concluded based on blockchain technology, the tracking function for the addition, modification and deletion of the progress related information of the specific clinical trial that is shared and managed is applied. It is preferable to carry out forgery prevention.

Remote CRO method using a blockchain according to an embodiment of the present invention, in the CRO providing server, the clinical trial request step (S100) receiving the request information of the specific clinical trial including the desired clinical plan from the client server, In the CRO providing server, a researcher group setting step (S200) of setting a specific researcher group matching the specific clinical trial inputted by the clinical trial request step (S100) among the researcher groups previously stored in the researcher server, providing the CRO. In the server, the progress request step (S300) of transmitting the progress request information of the specific clinical trial to the specific researcher group set by the researcher group setting step (S200), the CRA server, the progress request information of the specific clinical trial Based on the clinical trial preparation step for generating a custom CRF (Case Report Form) for the specific clinical trial to the researcher server (S400) In response to the progress request information of the specific clinical trial received by the progress request step (S300), the researcher server requests the progress of the task according to the specific clinical trial, and the clinical trial data generated according to the progress of the task. Clinical trial progress step (S500) to be input to the customized CRF received by the clinical trial preparation step (S400), CRA server, the request information of the specific clinical trial progress input by the clinical trial request step (S100) and By monitoring the clinical trial data input by the clinical trial progress step (S500), in the clinical trial management step (S600) and the CRA server to manage the work progress of the specific clinical trial, the pre-stored clinical trial data End of clinical trial to statistically analyze the clinical trial data received through the analysis system and to store and manage the statistical analysis results (S700), and after performing the progress request step (S300), in the CRO providing server, by entering a smart contract (smart contract) between the client server, the researcher server, the CRA server based on the blockchain technology It is preferable to further perform a blockchain fastening step (S310) of sharing and managing information related to the progress of a specific clinical trial between the smart contracts.

Furthermore, in the clinical trial management step (S600), the CRA server receives the clinical trial data generated based on the blockchain technology, converts it into an electronic CRF, and stores and shares it.

Furthermore, in the clinical trial termination step (S700), in the CRA server, it is preferable to store and manage the clinical trial data and the statistical analysis result data according to each specific clinical trial in a database.

Furthermore, the remote CRO method using the blockchain is related to the progress of the specific clinical trial transmitted and received at each step by the smart contract signed based on blockchain technology after performing the blockchain fastening step (S310). It is preferable to further perform the forgery tracking step (S320) of performing forgery prevention by applying the tracking function for sharing, managing, sharing, and managing the information related to the progress of the specific clinical trial that is shared and managed. Do.

The remote CRO system and the method using the blockchain of the present invention by the above configuration can apply the smart contract and data transparency of the blockchain to the overall process of the clinical trial in which there are many complex spatial and temporal constraints. It offers the advantage of providing a Contract Research Organization (CRO) service that maximizes spatial, economic, and time efficiency by providing a unified remote CRO cloud platform.

In addition, by adopting blockchain technology, we concluded a smart contract for each institution involved in the clinical trial, so that the transparency and reliability of the data between the project units (specific clinical trials) between the parties for all phases of the clinical trial. And there is an advantage to improve the security.

Specifically, clinical investigators (CRO, CRA) reduce the number of visits directly to the hospital, and clinical researcher through the image function, real-time information update function, remote access function included in the cloud platform in the remote CRO providing system Overcoming the spatial limitations between hospitals (doctors, doctors, etc.), sponsors (pharmacists, etc.), and clinical investigators (CRO, CRA, etc.) can reduce labor costs incurred by clinical trials and shorten the duration of clinical trial There is an advantage that can increase the spatial, economic, and time efficiency.

In addition, the introduction of blockchain technology ensures the protection and relevance of the trial agreement and related information between the parties to each institution involved in the clinical trial. Shares with institutions have the advantage that interested parties can verify their contents and increase their stability.

In addition, the verification results are also immediately shared, so that a quick response can be made, and in the case of forgery discovery, there is an advantage that the instant discovery, the sharing thereof, and the quick confirmation of the responsible person can be made.

1 is a view showing a remote CRO system using a blockchain according to an embodiment of the present invention.
2 is a flowchart illustrating a remote CRO method using a blockchain according to an embodiment of the present invention.

Hereinafter, with reference to the accompanying drawings will be described in detail a remote CRO system and method using the blockchain of the present invention. The drawings introduced below are provided by way of example so that the spirit of the invention to those skilled in the art can fully convey. Accordingly, the present invention is not limited to the drawings presented below and may be embodied in other forms. Also, like reference numerals denote like elements throughout the specification.

In this case, unless there is another definition in the technical terms and scientific terms used, it has the meaning commonly understood by those of ordinary skill in the art to which the invention belongs, and the gist of the invention in the following description and the accompanying drawings. The description of well-known functions and configurations that may unnecessarily obscure them will be omitted.

In addition, a system is a set of components including devices, instruments, means, and the like that are organized and regularly interact to perform the necessary functions.

Clinical trial is an experiment to confirm the safety and efficacy of drugs in humans in the development of medicines for the treatment or prevention of diseases. It is mainly conducted by pharmaceutical companies that develop medicines, and is not intended for drug development. There are also a number of relatively small research trials led by investigators.

In general, subjects participating in a clinical trial will visit a designated clinical trial participating institution or hospital periodically and undergo various tests during the trial period, and the test results, that is, the clinical trial data, will be reported in a case report form (CRF). Will be written to In this case, the case record form is a questionnaire of various forms used in clinical trials, and is a tool defined by a sponsor (pharmaceutical company) of a clinical trial in order to collect clinical trial data from a subject.

Therefore, all clinical data of each subject participating in the clinical trial is collected and recorded using a case record sheet.

Conventionally, a clinical researcher records the clinical trial data of test subjects directly on a case record sheet and inputs the recorded data into the system, and this process is repeated several times according to the clinical trial.

In addition, the CRO (Contract Research Organization) performs a series of processes to collect, organize and analyze different types of case record sheets received from clinical research researchers. Processes such as analysis are usually performed by a computerized processing method using dedicated software, and these computerized processing methods are usually performed by a manager with expertise due to the complexity and difficulty of the functions.

In other words, through the professional CRA (Clinical Research Associate), the CRO not only collects, organizes and analyzes the case record information, but also monitors whether the collected case record information matches the contents of the chart of the medical institution. In order to proceed with the CRA, the CRA directly visits the participating institutions or hospitals and performs the work repeatedly.

As a result, the computerized use of case records recorded by the clinical investigator causes unnecessary waste of human resources and costs, such as direct visits to the researcher's education. There is a problem that causes a problem, and even in the case of computerizing the case record sheet, there is a high possibility that the input error occurs, it is difficult to accurately maintain the clinical trial data.

In addition, as described above, due to the interests of each participating institution, hospital, or test subject, there is a problem in that a lot of cost and time for guaranteeing trust are generated when performing a task requiring trust.

In order to overcome this, by entering into a smart contract based on blockchain technology, sharing and managing information related to the progress of clinical trials and preventing forgery and alteration, it is possible to reduce inevitable costs for trust assurance. Immediate treatment also has the advantage of being possible.

The block chain technology is a technology that makes digital data reliable, and means that a plurality of nodes form a trust relationship in digital through a method of sharing and verifying the same data.

In other words, blockchain technology is a technology that ensures that transaction integrity and transaction history are not forged. For this reason, it is necessary to replicate (share) and verify the correctness of the transaction history by numerous nodes in the blockchain network connected to each interest. Because.

Therefore, blockchain technology has the advantage that the contents can be trusted without a separate guarantee of trust.

For example, in the case of a bank network, if the bank that maintains the transaction data is the guarantee entity for the transaction, in the case of the blockchain network, all the nodes participating in the blockchain have an assurance entity that has the same book of transaction data. Same as

In the remote CRO system and method using the blockchain according to an embodiment of the present invention, such nodes are connected to the CRO providing server 100, the client server 200, the researcher server 300, the CRA server 400, etc. It is preferred to be configured.

Remote CRO system and method using the blockchain according to an embodiment of the present invention by entering into a smart contract (smart contract) based on blockchain technology to provide a remote CRO platform to integrate the overall work of clinical trials into one By doing so, the Clinical Research Associate (CRA), who is in charge of the clinical trial, reduces the number of visits to the hospital, and utilizes the imaging, real-time information, and remote access functions provided within the remote CRO platform. In addition to maximizing spatial and economic and time-efficiency by reducing the number of people and costs invested in the project, it also improves the transparency, reliability and security of the data between the parties (project-specific) for all phases of the trial. It can be strengthened to prevent forgery and alteration.

In addition, the present invention relates to a remote CRO system and a method using a blockchain that can improve the usability of data since information is shared among all nodes that have signed a smart contract.

Specifically, the remote CRO system and method using the blockchain according to an embodiment of the present invention, the client (pharmaceutical company, clinical researcher, etc.), researchers (doctors, hospitals, clinical trial participants, etc.), CRO / Enhanced communication between CRAs enables document collaboration through secure access to remote CRO platforms, real-time sharing of clinical trials, and rapid sharing of critical information through real-time pop-ups. Can be done.

In addition, documents can be developed quickly according to the clinical trial, and the electronic signature function can be used to quickly prepare for the clinical trial study, as well as the Institutional Review Board (IRB) information list for each hospital. In addition, we may select a hospital optimized for a specific clinical trial and proceed with the clinical trial.

In addition, it can overcome the limitations of online communication, including video call function, online lecture function, video conferencing function, and computer remote access.

In addition, it is possible to easily calculate the error information included in the clinical trial data according to the clinical trial, to obtain a high-precision clinical trial results, and to prepare a result report according to the results quickly, so that the conventional CRO has It can effectively solve the complexities and difficulties.

In addition, by providing a remote CRO platform by signing smart contracts based on blockchain technology, sharing and managing information related to the progress of specific clinical trials can be shared, and forgery prevention can be performed by applying tracking functions for addition, modification and deletion. It can even improve the usability of the data.

1 is a view showing a remote CRO system using a block chain according to an embodiment of the present invention with reference to Figure 1 will be described in detail a remote CRO system using a block chain according to an embodiment of the present invention.

Remote CRO system using a blockchain according to an embodiment of the present invention, including the CRO that manages the clinical trial, the CRO providing server 100 for conducting the clinical trial, a number of pharmaceutical companies or clinical trial researchers It may be configured to include a client server 300, including a researcher server 300, including a doctor, a hospital, a clinical trial participating organization, and a CRA server 400 including a plurality of CRA or another CRO.

In this case, as shown in FIG. 1, the client server 200, the researcher server 300, and the CRA server 400 are connected to the CRO providing server 100, respectively, but participate in a clinical trial. In order to protect the information of the examiner, and to protect various clinical trial data generated due to the clinical trial, the security server 500 may be further included.

In detail, it is most preferable that the client server 200, the researcher server 300, and the CRA server 400 are connected to the CRO providing server 100 through the security server 500.

The security server 500 performs security of information (data) transmitted and received between the CRO providing server 100, the client server 200, the researcher server 300, and the CRA server 400 according to a preset security policy. In this case, the security policy is preferably any one of well-known techniques.

The CRO providing server 100 may receive input request information of a specific clinical trial including a desired clinical plan from a plurality of pharmaceutical companies or clinical trial researchers included in the client server 200. have.

The CRO providing server 100 sets a specific researcher group matching the specific clinical study among the previously stored researcher groups when the request information of the specific clinical trial progress is input, and sets the specific researcher group to the specific researcher group. Information on the progress of a particular clinical trial can be communicated. Through this, it is desirable to proceed with the special clinical trial in the specific group of researchers later.

At this time, it is preferable that the group of researchers stored in advance is a doctor, a hospital, or a clinical trial participating institution included in the researcher server 300.

That is, when the request information for the specific clinical trial is input, the CRO providing server 100 selects a specific researcher group optimized for the specific clinical trial among the researcher group included in the researcher server 300. In addition, by transmitting that the request information of the specific clinical trial progress is input to the selected specific researcher group, the specific clinical trial may be progressed.

In addition, the CRO providing server 100 is a database for each specific clinical trial information received from the client server 200, the researcher server 300 and the CRA server 400 generated and transmitted in the course of the specific clinical trial progress Can be stored and managed, and it is desirable to store it separately.

In addition, the CRO providing server 100 by sharing the information related to the progress of the specific clinical trial by entering into a smart contract (smart contract) between each institution associated with the specific clinical trial based on the blockchain technology and It is preferable to further include a blockchain management module 110 that can enhance the forgery prevention, data safety, stability, and reliability through this.

Specifically, in addition to the secured database, prior to the progress of the task according to the specific clinical trial in the researcher server 300 according to the request information of the specific clinical trial of the client server 200, that is, Prior to the actual progress of the specific clinical trial in the selected group of researchers,

Through the blockchain management module 110, a smart contract is concluded between the client server 200, the researcher server 300, and the CRA server 400 based on blockchain technology to proceed with the specific clinical trial. By sharing relevant information, you can prevent forgery and enhance the safety, stability and reliability of your data.

At this time, the smart contract is an electronic contract made up of digital instructions based on a blockchain. In a remote CRO system using a blockchain according to an embodiment of the present invention, information related to the progress of a specific clinical trial between a sponsor and a researcher is provided. And the logic and code of conduct that everyone involved in the particular clinical trial should follow, preferably including a legal basis for it.

When entering into a smart contract, the contract contents can be automatically executed in each node (CRO providing server 100, client server 200, researcher server 300, CRA server 400, etc.) according to the contract conditions. In addition, since it is a digital contract, it is possible to clearly check the contract result according to the conditions, and has the advantage of immediately implementing the contract contents.

In addition, contracts are created and executed through consensus among their connected nodes, so that contracts can be concluded without the complicated process of implementing them.

The client server 200 is preferably connected to the CRO providing server 100 through the security server 500, the specific request by entering the specific clinical trial progress request information to the CRO providing server 100 You may request to proceed with a clinical trial. To this end, the client server 200 is preferably configured to include a number of pharmaceutical companies or clinical trial researchers that can request the progress of the particular clinical trial, as described above.

The request for progress of the specific clinical trial in the client server 200 inputs the desired progress information of the specific clinical trial to the CRO providing server 100 through a terminal connected to the sponsor server 200. desirable.

The researcher server 300 is preferably connected to the CRO providing server 100 via the security server 500, doctors, hospitals included in the researcher server 300 is connected to, Or, you can ask the participating institution to proceed with the work according to the specific clinical trial.

In detail, the CRO providing server 100 selects a specific researcher group that is most optimized for the specific clinical trial, and delivers the request for progress of the specific clinical trial to the selected specific researcher group, thereby transmitting the specific researcher. Groups can allow specific clinical trials to proceed.

Through this, the researcher server 300 is received from the CRO providing server 100 that the progress request information of the specific clinical trial is input to a specific researcher group.

In addition, the researcher server 300 is a clinical trial that is generated according to the progress of the specific clinical trial from the doctor, hospital or clinical trial participant in which the specific clinical trial proceeds among the included doctor, hospital or clinical trial part The data may be received and transmitted to the CRO providing server 100.

At this time, the input of the clinical trial data is preferably made based on a customized Case Report Form (CRF) provided through a terminal connected with the researcher server (300).

The customized CRF will be described later in detail through the CRA server 400.

The CRA server 400 is preferably connected to the CRO providing server 100 via the security server 500, the connected CRA, CRO and the like received from the client server 200, the CRO providing server Progress of the specific clinical trial using the request information of the specific clinical trial received through the 100, the clinical trial data received from the researcher server 300 and transmitted through the CRO providing server 100, Status information can be generated in real time.

In addition, it is preferable to manage the work progress of the specific clinical trial based on the real-time progress information of the specific clinical trial generated.

In detail, the CRA server 400 receives the progress request information of the specific clinical trial and the clinical trial data through a terminal connected to the CRA server 400, and generates progress information of the specific clinical trial in real time and uses the same. Manage the progress of the specific clinical trial.

At this time, the CRA server 400 may generate a customized CRF based on the request information of the specific clinical trial received from the connected CRA, CRO, etc., and transmit the generated CRF to the CRO providing server 100.

Through this, the researcher server 300 can check the customized CRF provided through the connected terminal, by inputting the clinical trial data into the provided custom CRF, the clinical trial data generated without additional process It can be delivered to the CRO providing server 100 in real time.

The CRA server 400 preferably stores and shares the clinical trial data received from the researcher server 300 by converting it into an electronic CRF (e-CRF) based on a blockchain technology.

That is, the CRA server 400 may generate a customized CRF based on the received request information of the specific clinical trial and receive the clinical trial data from the researcher server 300 according to the customized CRF.

At this time, the clinical trial data input according to the customized CRF, like the conventional clinical research, it is difficult to open the database to share with each other, or accidents such as data tampering or unauthorized copying may occur in the process of sharing.

Therefore, in order to prevent this, the CRA server 400 converts the clinical trial data received through the customized CRF into an e-CRF using a smart contract concluded based on blockchain technology to store and share. It is desirable to.

Through this, it is possible to share the clinical trial data converted into the e-CRF among the nodes that have a smart contract based on the blockchain technology, so that the clinical trial data according to the interests of each node Can be verified or further shared.

The CRA server 400 performs the management of the work progress of the specific clinical trial, and through the analysis system of pre-stored clinical trial data, the performance is converted into the e-CRF received from the server 300 Statistical analysis of clinical trial data is desirable.

In addition, it is preferable to store and manage the clinical trial data and the statistical analysis result data according to each specific clinical trial by database.

In detail, the CRA server 400 may determine an error / abnormal of the clinical trial data through an analysis system of the clinical trial data stored in advance, and determine whether the clinical trial data is missing. Improve the accuracy of clinical trial data.

To this end, the CRA server 400 may set the error input range that can be generated of the specific clinical trial received from the client server 200 through an analysis system of pre-stored clinical trial data, and set the error. Statistical analysis (comparative analysis) of the clinical trial data converted into the e-CRF received from the researcher server 300 based on the input range, the clinical trial data out of the error input range is determined as abnormal clinical trial data By classifying and managing the data, abnormal clinical trial data can be prevented from being derived later.

In addition, the clinical plan of the specific clinical trial inputted from the sponsor server 200 and the clinical trial data converted into the e-CRF received from the researcher server 300 are statistically analyzed (comparatively analyzed). By determining whether the test data is missing or not, the clinical trial data is classified as the missing clinical trial data and classified and managed, thereby preventing the missing clinical trial data from being included in the process of deriving the clinical trial result later. .

Through this process, the accuracy of the clinical trials can be further improved, and in the past, the CRA directly visited the researcher and checked the clinical trial data received to determine abnormality / error / missing. The remote CRO system using a blockchain according to an embodiment can perform this process remotely without a direct visit through the CRO providing server 100, thereby maximizing spatial / economical / temporal efficiency.

In addition, the CRA server 400 in accordance with the pre-stored result report form, the statistical data for performing the statistical analysis, that is, the normal clinical data by performing a database for each specific clinical trial statistical analysis result data It can be stored and managed by, and the final result of the clinical trial can be derived by passing the statistical analysis result data according to an external request.

The CRO providing server 100 authenticates the information generated and received by the client server 200, the researcher server 300, and the CRA server 400 through an electronic signature system stored in advance, and then each specific clinical. By storing and managing a database for each test, the processes can be performed remotely without a direct visit through the CRO providing server 100, thereby maximizing spatial, economical and temporal efficiency.

In addition, the remote CRO system using a blockchain according to an embodiment of the present invention through the CRO providing server 100, the external request, that is, the client server 200, the researcher server 300 and the CRA When a video call request is generated from any one of the servers 400, the video call system may be provided through the CRO providing server 100. Through the video call system, the video call function, the online lecture function, the video conferencing function, the computer remote access function, and the like can be performed, thereby overcoming the spatial communication in the specific clinical trial and proceeding quickly.

In addition, the CRO providing server 100 is generated separately from the CRA server 400, the client server 200, the researcher server 300 and the CRA server 400 is delivered through the security server 500. Information related to the progress of the specific clinical trial can be stored and managed by making a database for each specific clinical trial.

At this time, as described above, by using a smart contract signed on the basis of blockchain technology, by applying a tracking function for the addition, modification, and deletion of the information related to the progress of the specific clinical trial that is shared management to prevent forgery Can be performed.

For example, after a smart contract is signed between the client server 200, the researcher server 300, and the CRA server 400, the client server 200 is included in the progress request information of the specific clinical trial. In the case of modifying the 'contract information', a notification function for this is transmitted to the researcher server 300 and the CRA server 400 by the tracking function, and the notification details are provided to the CRO providing server 100 and the security server 500. The record remains.

In addition, smart contracts based on blockchain technology can improve data efficiency / availability by sharing information related to the progress of the specific clinical trial that is managed and managed.

For example, when a researcher who does not recruit a patient in a clinical trial does not receive a research fee, when the smart contract is concluded and the deposit and withdrawal function is automatically linked, the researchers' research cost included in the researcher server 300 is included. By improving the transparency of the 'payment contents' and minimizing the issues related to them, the time, space and economic aspects can be improved.

In particular, since all activities to improve the quality of data through the blockchain are shared (opened) by the conclusion of smart contracts, it is possible to manage data based on transparency and improve the quality of data. In addition, the safety of your data is guaranteed.

2 is a flowchart illustrating a remote CRO method using a block chain according to an embodiment of the present invention with reference to FIG. 2. The remote CRO method using a block chain according to an embodiment of the present invention will be described in detail.

Remote CRO method using a blockchain according to an embodiment of the present invention, as shown in Figure 2, clinical trial request step (S100), researcher group setting step (S200), progress request step (S300), clinical Including trial preparation stage (S400), clinical trial progress stage (S500), clinical trial management stage (S600), and clinical trial termination stage (S700), including a CRO that oversees the clinical trial CRO providing server 100, a client server 200, including a plurality of pharmaceutical companies or clinical research researchers, a researcher server 300, including a doctor, a hospital, a clinical trial participating institution, and a plurality of CRA or another Each step is preferably performed in a CRA server 400 including a CRO and the like.

The clinical trial request step (S100) is a Clin providing server 100, the client wants to proceed with the clinical trial, that is, the desired clinical from a number of pharmaceutical companies or clinical trial researchers included in the client server 200 You may be asked to provide progress request information for a specific clinical study, including a protocol.

In the researcher group setting step (S200), the CRO providing server 100 receives the progress request information of the specific clinical trial by the clinical trial request step (S100), and is included in the researcher server 300. It is desirable to set up a specific researcher group that is optimized for the specific clinical trial among the researcher group.

The progress request step (S300) by the CRO providing server 100, by transmitting that the request information of the specific clinical trial progress to the specific researcher group set in the researcher group setting step (S200), the specific clinical You may request to proceed with the examination.

In the clinical trial preparation step (S400), the CRA server 400 may generate a customized CRF for the specific clinical trial based on the request information of the specific clinical trial and deliver the customized CRF to the researcher server 300. That is, the CRA server 400 generates a customized CRF based on the progress information of the specific clinical trial received from the connected CRA, CRO, etc., and delivers the customized CRF to the CRO providing server 100 to the researcher server 300. ) Can be delivered.

The clinical trial progress step (S500) is to request the progress of work according to the specific clinical trial in the researcher server 300, according to the progress request information of the specific clinical trial received by the progress request step (S300) and In addition, the clinical trial data generated according to the work progress may be input into the customized CRF received by the clinical trial preparation step (S400).

In detail, the clinical trial progress step (S500) through the CRO providing server 100, the researcher receives the customized CRF generated in the clinical trial preparation step (S400), the progress of the specific clinical trial It is possible to enter the clinical trial data generated according to.

In detail, the researcher server 300 can check the customized CRF provided through the connected terminal, and by inputting the clinical trial data into the provided customized CRF, the clinical trial data generated without additional process. It can be delivered to the CRO providing server 100 in real time.

The clinical trial management step (S600) is received by the CRA server 400, the progress request information of the specific clinical trial received by the clinical trial request step (S100) and the clinical trial progress step (S500) The clinical trial data can be monitored to manage the progress of the particular clinical trial.

At this time, the clinical trial management step (S600) may receive the clinical trial data generated based on the blockchain technology from the CRA server 400, convert it into an e-CRF, and store and share it.

In other words, the clinical trial management step (S600) generates a customized CRF based on the request information of the specific clinical trial received from the CRA server 400, according to the customized CRF from the researcher server 300. The clinical trial data may be input.

At this time, the clinical trial data input according to the customized CRF, like the conventional clinical research, it is difficult to open the database to share with each other, or accidents such as data tampering or unauthorized copying may occur in the process of sharing.

Therefore, in order to prevent this, the CRA server 400 converts the clinical trial data received through the customized CRF into an e-CRF by using a smart contract concluded based on blockchain technology, and stores and shares them. It is desirable to manage.

Through this, it is possible to share the clinical trial data converted into the e-CRF among the nodes that have a smart contract based on the blockchain technology, so that the clinical trial data according to the interests of each node Can be verified or further shared.

The clinical trial termination step (S700) may determine the error / abnormality of the clinical trial data, through the analysis system of the clinical trial data stored in advance in the CRA server 400, missing the clinical trial data By determining whether or not, it is possible to improve the accuracy of the clinical trial data.

In detail, the CRA server 400 may set a possible error input range of the specific clinical trial received from the sponsor server 200 through an analysis system of pre-stored clinical trial data. By comparing and analyzing the clinical trial data converted into the e-CRF received from the researcher server 300 based on the error input range, the clinical trial data out of the error input range is determined as abnormal clinical trial data and classified and managed. Thus, abnormal clinical trial data may be prevented from being included in the process of deriving the clinical trial results later.

In addition, by comparing and analyzing the clinical plan of the specific clinical trial received from the client server 200 and the clinical trial data based on the customized CRF received from the researcher server 300, to determine whether the clinical trial data is missing The clinical trial data is classified as missing clinical trial data according to the absence of the clinical trial data, and thus the clinical trial data can be classified and managed to prevent the inclusion of the missing clinical trial data in the process of deriving the clinical trial results later.

Through this process, the accuracy of the clinical trials can be further improved, and in the past, the CRA directly visited the researcher and checked the clinical trial data received to determine abnormality / error / missing. The remote CRO system using a blockchain according to an embodiment can perform this process remotely without a direct visit through the CRO providing server 100, thereby maximizing spatial / economical / temporal efficiency.

In addition, the clinical trial termination step (S700), in the CRA server 400, the clinical trial data is stored in each database for each specific clinical trial and stored and managed as statistical analysis result data, the result data according to an external request Can be passed.

That is, according to the pre-stored result report form, the clinical trial data, that is, the normal clinical trial data, which have been statistically analyzed, can be databased for each specific clinical trial and stored and managed as the result data. According to the request of the statistical analysis result data can be delivered to obtain the final clinical trial results.

In addition, the remote CRO method using a blockchain according to an embodiment of the present invention through the CRO providing server 100, the external request, that is, the client server 200, the researcher server 300 and the CRA When a video call request is generated from any one of the servers 400, the CRO providing server 100 may provide a video call system for at least one step selected from each step. Through the video call system, the video call function, the online lecture function, the video conferencing function, the computer remote access function, and the like can be performed, thereby overcoming the spatial communication in the specific clinical trial and proceeding quickly.

Remote CRO method using a block chain according to an embodiment of the present invention, as shown in Figure 2, in the block chain management module 110 of the CRO providing server 100, the progress request step (S300) After performing, the block chain fastening step (S310) is preferably performed, and after performing the blockchain fastening step (S310), it is preferable to perform the forgery tracking step (S320) for each step. .

In the blockchain fastening step (S310), the smart contract between the client server 200, the researcher server 300, and the CRA server 400 is concluded based on blockchain technology so that the information related to the progress of the specific clinical trial is smart. Share management between contracted parties.

Through the execution of the smart contract, information related to the progress of the specific clinical trial can be shared, thereby preventing forgery and strengthening the safety / stability / reliability of the data.

A smart contract is an electronic contract made up of digital instructions based on a blockchain. In a remote CRO site system using a blockchain according to an embodiment of the present invention, information related to the progress of a specific clinical trial between a sponsor and a researcher is defined. And the logic and code of conduct that everyone involved in the particular clinical trial should adhere to, preferably including a legal basis for it.

When entering into a smart contract, the contract contents can be automatically executed in each node (CRO providing server 100, client server 200, researcher server 300, CRA server 400, etc.) according to the contract conditions. In addition, since it is a digital contract, it is possible to clearly check the contract result according to the conditions, and has the advantage of immediately implementing the contract contents.

In addition, contracts are created and executed through consensus among their connected nodes, so that contracts can be concluded without the complicated process of implementing them.

The forgery tracking step (S320) is a smart contract signed on the basis of blockchain technology, sharing and managing the progress-related information of the specific clinical trials transmitted and received at each step, and related to the progress of the specific clinical trials shared management Forgery prevention can be performed by applying tracking functions for adding, modifying, and deleting information.

For example, after a smart contract is signed between the client server 200, the researcher server 300, and the CRA server 400, the client server 200 is included in the progress request information of the specific clinical trial. In the case of modifying the 'contract information', a notification function for this is transmitted to the researcher server 300 and the CRA server 400 by the tracking function, and the notification details are provided to the CRO providing server 100 and the security server 500. The record remains.

In addition, smart contracts based on blockchain technology can improve data efficiency / availability by sharing information related to the progress of the specific clinical trial that is managed and managed.

For example, when a researcher who does not recruit a patient in a clinical trial does not receive a research fee, when the smart contract is concluded and the deposit and withdrawal function is automatically linked, the researchers' research cost included in the researcher server 300 is included. By improving the transparency of the 'payment contents' and minimizing the issues related to them, the time, space and economic aspects can be improved.

In particular, since all activities to improve the quality of data through the blockchain are shared (opened) by the conclusion of smart contracts, it is possible to manage data based on transparency and improve the quality of data. In addition, the safety of your data is guaranteed.

As described above, the present invention has been described by specific embodiments such as specific components and the like. However, this is merely provided to help a more general understanding of the present invention, and the present invention is limited to the above embodiment. However, various modifications and variations are possible to those skilled in the art to which the present invention pertains.

Therefore, the spirit of the present invention should not be limited to the described embodiments, and all the things equivalent to or equivalent to the claims as well as the following claims will fall within the scope of the present invention. .

100: CRO server
110: Blockchain Management Module
200: client server
300: researcher server
400: CRA Server
500: security server

Claims (10)

Receiving input request information of a specific clinical trial including a desired clinical plan from the outside, a specific researcher group matching the specific clinical trial is set among previously stored researcher groups, and the specific researcher group is set as the specific researcher group. CRO providing server 100 for transmitting the progress request information of the test;
A client server 200 connected to the CRO providing server 100 and receiving the request information of a specific clinical trial progress desired and transmitting the received information to the CRO providing server 100;
Connected to the CRO providing server 100, receives the progress request information of the specific clinical trial, requests the progress of the task according to the specific clinical trial, receives the clinical trial data generated according to the progress of the CRO Researcher server 300 to deliver to the providing server 100; And
The specific clinical trial is connected to the CRO providing server 100 by using the request information of the specific clinical trial received from the client server 200 and the clinical trial data received from the researcher server 300. A CRA server 400 for generating progress information in real time and managing the progress of the specific clinical trial according to the progress information;
Including;
The CRO providing server 100 is
Prior to the progress of the task according to the specific clinical trial in the researcher server 300 according to the request information of the specific clinical trial progress of the client server 200, the requestor server 200, the researcher based on blockchain technology After entering into a smart contract between the server 300 and the CRA server 400, thereafter, all progress related information generated during the specific clinical trial is shared in real time with each other that entered into the smart contract in real time. Blockchain management module 110 to perform the management;
Remote CRO system utilizing a blockchain, characterized in that it further comprises.

The method of claim 1,
The CRA server 400
Based on the request information of the specific clinical trial received from the client server 200, generates a customized CRF (Case Report Form) for the specific clinical trial and delivers it to the CRO providing server 100,
The researcher server 300 is
Receiving the customized CRF generated by the CRA server 400, and remotely using the block chain, characterized in that input the clinical trial data generated in accordance with the progress of the work according to the specific clinical trial in the customized CRF CRO system.
The method of claim 2,
The CRA server 400
Remote CRO system using a block chain, characterized in that by converting the clinical trial data received from the researcher server (300) using the smart contract concluded e-CRF (electronic CRF) to store and share.
The method of claim 3, wherein
The remote CRO system utilizing the blockchain
A security server 500 connected with the CRO providing server 100;
More,
The client server 200, the researcher server 300 and the CRA server 400 is connected to the CRO providing server 100 via the security server 500,
The security server 500 performs the security of information transmitted and received between the CRO providing server 100, the client server 200, the researcher server 300 and the CRA server 400 in accordance with a predetermined security policy. Remote CRO system utilizing blockchain
The method of claim 3, wherein
The CRA server 400
To perform the management of the progress of the specific clinical trial, and statistical analysis of the clinical trial data received from the researcher server 300 through the pre-stored clinical analysis data analysis system,
Remote CRO system using a block chain, characterized in that the database of the clinical trial data and the statistical analysis result data according to each specific clinical trial to store and manage.
The method of claim 5,
The CRO providing server 100 is
Although the client-related server 200, the researcher server 300 and the CRA server 400 generated and forwarded the information related to the progress of the specific clinical trial for each specific clinical trial to store and manage the database,
Through the blockchain management module 110, by the smart contract concluded based on blockchain technology, the tracking function for the addition, modification and deletion of the progress related information of the specific clinical trial that is shared and managed is applied. Remote CRO system utilizing a blockchain, characterized in that to perform a forgery prevention.
In the CRO providing server, the clinical trial request step (S100) receiving input request information of a specific clinical trial including a desired clinical plan from the sponsor server;
In the CRO providing server, a researcher group setting step (S200) of setting a specific researcher group matching the specific clinical trial received by the clinical trial request step (S100) among the researcher group previously stored in the researcher server;
A progress request step (S300) of delivering a request for progress of the specific clinical trial to the specific researcher group set by the researcher group setting step (S200) in a CRO providing server;
A clinical trial preparation step of generating a customized case report form (CRF) for the specific clinical trial based on the request information of the specific clinical trial in the CRA server and delivering the generated CRF to the researcher server (S400);
In the researcher server, request the progress of the task according to the specific clinical trial according to the progress request information of the specific clinical trial received by the progress request step (S300), and the clinical trial data generated according to the progress of the clinical trial Clinical trial progress step (S500) for inputting the customized CRF received by the test preparation step (S400);
In the CRA server, by monitoring the clinical trial data received by the clinical trial progress step (S500) and the progress request information of the specific clinical trial input by the clinical trial request step (S100), Clinical trial management step of managing the work progress (S600); And
In the CRA server, the clinical trial termination step (S700) for statistical analysis of the clinical trial data received through the pre-stored clinical analysis data analysis system, and storing and managing the statistical analysis results;
It consists of
After performing the progress request step (S300),
In the CRO providing server, a block chain conclusion step (S310) of signing a smart contract between the client server, the researcher server, and the CRA server based on the blockchain technology;
Further, afterwards, the clinical trial preparation step (S400), clinical trial progress step (S500), clinical trial management step (S600) and clinical trial end step (S700) generated while proceeding with the specific clinical trial Remote CRO method using a block chain, characterized in that the instantaneous sharing management between each other that concluded the smart contract in real time all the related information.

The method of claim 7, wherein
The clinical trial management step (S600)
In the CRA server, the remote CRO method using the block chain, characterized in that the received clinical trial data generated by using the smart contract signed, converted into e-CRF (electronic CRF) to store and share.
The method of claim 8,
The clinical trial termination step (S700) is
In the CRA server, the remote CRO method using a block chain, characterized in that the database for the clinical trial data and the statistical analysis result data for each specific clinical trial, and store and manage.
The method of claim 9,
Remote CRO method using the blockchain
After performing the blockchain fastening step (S310),
Sharing and managing the progress related information of the specific clinical trials transmitted and received at each step by the smart contract signed based on blockchain technology,
Forgery tracking step (S320) to perform a forgery prevention by applying a tracking function for the addition, modification, deletion of the information related to the progress of the specific clinical trial that is shared management (S320);
Remote CRO method utilizing a blockchain, characterized in that further performing.

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