Intelligent supervision of drug clinical trial requirements, medicine transfer box and working method

Abstract

This invention discloses an intelligent monitoring drug transport box and its operating method for drug clinical trials, which can ensure real-time area monitoring, opening permission management, and data traceability of drugs during transport. Its control unit includes: a data transmission security module, an encrypted communication module, a temporary opening authorization module, and a location-based service module.

Description

Technical Field

[0001] This invention relates to the technical fields of network communication technology, encryption technology, blockchain technology, and location-based services, and in particular to an intelligent monitoring drug transport box for clinical trials, and a method for operating such an intelligent monitoring drug transport box for clinical trials. Background Technology

[0002] With the rise of the "patient-centered" approach in drug development, decentralized drug clinical trials (DCTs) have become a core guiding principle and a new clinical trial model. Under this model, DCTs are currently in a phase of active exploration and advancement, with the industry exploring implementation in various aspects such as electronic informed consent, electronic payment, and remote follow-up in recent years. Given that decentralized drug clinical trials involve transforming traditional centralized management into a decentralized approach, there is a need for multiple branch medical institutions to handle the transportation and administration of investigational drugs. In this process, the safety and oversight of drug transportation are particularly critical, as traditional transportation methods are no longer sufficient. Real-time monitoring of drug transportation status is essential for preventing loss, theft, or misuse en route, ensuring that drugs arrive at their destination safely and without error. Furthermore, the detailed transportation routes and key event data recorded by the monitoring system, such as drug retrieval permissions and opening records, not only enhance drug traceability but also enable rapid location and response in case of problems, which is crucial for drug recalls and emergency handling.

[0003] Compliance with regulatory requirements is a challenge that drug development companies and medical institutions must face. Regulations related to drug clinical trials impose strict requirements on aspects such as temperature control, time limits, and data traceability during drug transportation. Drug transport boxes with advanced monitoring capabilities can help development companies and medical institutions ensure that the transportation process meets requirements, avoiding compliance risks and corresponding penalties. In emergency situations, such as drug recalls involving serious adverse events, these transport boxes can quickly provide flow information, assisting companies in taking timely measures to reduce potential risks and losses. Therefore, establishing a drug transport box that meets the needs of decentralized intelligent monitoring of drug clinical trials is of great significance for ensuring the smooth progress of drug development, protecting public health, enhancing corporate reputation, and complying with international trade rules. Summary of the Invention

[0004] To overcome the shortcomings of existing technologies, the technical problem to be solved by the present invention is to provide an intelligent monitoring drug transport box for the needs of drug clinical trials, which can ensure real-time regional monitoring, access control management, and data traceability of drugs during the transport process.

[0005] The technical solution of this invention is: an intelligent monitoring drug transport box for clinical trials, the control unit of which includes:

[0006] The data transmission security module supports multiple encryption standards, including AES and SM4 symmetric encryption, to provide high-strength encryption for transmitted data, combined with authentication and digital signatures.

[0007] The transshipment box is equipped with a pre-installed authoritative CA certificate and a public-private key pair bound to the transshipment box information, and is authenticated through a CA signature certificate;

[0008] The encrypted communication module uses a combination of asymmetric encryption and symmetric keys. It utilizes key exchange protocols, including Diffie-Hellman, to ensure that both parties in the session securely negotiate a shared key for subsequent symmetric encrypted communication. The sender uses its private key to sign the data, while the receiver uses the corresponding public key to verify it.

[0009] The temporary unpacking authorization module supports both remote online and offline authorization modes for emergency situations. Online authorization issues signed instructions through encrypted communication channels, while offline authorization uses multi-factor authentication codes and authorization codes generated in the background. Once the network connection is restored, it synchronizes the operation records during the offline period to the central monitoring system and generates a detailed event report.

[0010] The location-based service module obtains the current location of the positioning device and provides information resources and basic services to the positioning device via the mobile Internet. First, it determines whether the transfer route of the medicine transfer box deviates from the preset route. Second, based on the current location of the transfer box, it determines whether the supervised medicine transfer box is within the preset electronic fence that can be opened. If it is not within this electronic fence, the on-site operator's request to open the box is rejected.

[0011] This invention supports multiple encryption standards, including AES and SM4 symmetric encryption, for high-strength encryption of transmitted data, combined with authentication and digital signatures. The transshipment box is equipped with a pre-installed authoritative CA certificate and a public-private key pair bound to the box information, authenticated through the CA signature certificate. It employs a combination of asymmetric encryption and symmetric keys, utilizing key exchange protocols including Diffie-Hellman to ensure that both parties securely negotiate a shared key for subsequent symmetric encrypted communication. The sender signs the data using their private key, while the receiver verifies it using the corresponding public key. For emergency situations, it supports both remote online and offline authorization modes. Online authorization uses encrypted communication... The system issues signed instructions via email, and offline authorization uses multi-factor authentication codes and authorization codes generated in the background. Once the network connection is restored, it synchronizes the offline operation records to the central monitoring system and generates a detailed event report. It obtains the current location of the positioning device and provides information resources and basic services to the positioning device via the mobile internet. First, it determines whether the transport route of the medicine transport box deviates from the preset route. Second, based on the current location of the transport box, it determines whether the monitored medicine transport box is within the preset allowed electronic fence. If it is not within this electronic fence, the on-site operator's request to open the box is rejected. Therefore, it can ensure real-time regional monitoring, box opening permission management, and data traceability of medicines during the transport process.

[0012] A method for operating an intelligent, monitored drug transport box for clinical trial needs is also provided, comprising the following steps:

[0013] (1) Data transmission supports multiple encryption standards including AES and SM4 symmetric encryption to encrypt transmitted data with high strength, combined with identity verification and digital signature; the transshipment box is equipped with a pre-installed authoritative CA certificate and a public-private key pair bound to the transshipment box information, and is authenticated through CA signature certificate;

[0014] (2) Encrypted communication adopts a combination of asymmetric encryption and symmetric key, and uses a key exchange protocol including Diffie-Hellman to ensure that the two parties in the session securely negotiate a shared key for subsequent symmetric encrypted communication; the sender uses the private key to sign the data, while the receiver uses the corresponding public key to verify it.

[0015] (3) Temporary unpacking authorization: In case of emergency, it supports two modes: remote online authorization and offline authorization. Online authorization is issued through encrypted communication channels with signed instructions, while offline authorization is issued through multi-factor authentication code and authorization code generated in the background. Once the network connection is restored, it will synchronize the operation records during the offline period to the central monitoring system and generate a detailed event report.

[0016] (4) Location-based services: obtain the current location of the positioning device and provide information resources and basic services to the positioning device through the mobile Internet; first, determine whether the transfer route of the medicine transfer box deviates from the preset route; second, determine whether the supervised medicine transfer box is within the preset electronic fence that can be opened based on the current location of the transfer box; if it is not within the electronic fence, refuse the on-site operator's request to open the box. Attached Figure Description

[0017] Figure 1 This is a flowchart illustrating the working method of an intelligent monitoring drug transport box for drug clinical trials according to the present invention. Detailed Implementation

[0018] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of the present invention.

[0019] It should be noted that the term "comprising" and any variations thereof in the specification, claims and accompanying drawings of this invention are intended to cover non-exclusive inclusion. For example, a process, method, apparatus, product or device that includes a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products or devices.

[0020] The intelligent, monitored drug transport box required for clinical trials of this drug has a control unit that includes:

[0021] The data transmission security module supports multiple encryption standards, including AES and SM4 symmetric encryption, to provide high-strength encryption for transmitted data, combined with authentication and digital signatures.

[0022] The transshipment box is equipped with a pre-installed authoritative CA certificate and a public-private key pair bound to the transshipment box information, and is authenticated through a CA signature certificate;

[0023] The encrypted communication module uses a combination of asymmetric encryption and symmetric keys. It utilizes key exchange protocols, including Diffie-Hellman, to ensure that both parties in the session securely negotiate a shared key for subsequent symmetric encrypted communication. The sender uses its private key to sign the data, while the receiver uses the corresponding public key to verify it.

[0024] The temporary unpacking authorization module supports both remote online and offline authorization modes for emergency situations. Online authorization issues signed instructions through encrypted communication channels, while offline authorization uses multi-factor authentication codes and authorization codes generated in the background. Once the network connection is restored, it synchronizes the operation records during the offline period to the central monitoring system and generates a detailed event report.

[0025] The location-based service module obtains the current location of the positioning device and provides information resources and basic services to the positioning device via the mobile Internet. First, it determines whether the transfer route of the medicine transfer box deviates from the preset route. Second, based on the current location of the transfer box, it determines whether the supervised medicine transfer box is within the preset electronic fence that can be opened. If it is not within this electronic fence, the on-site operator's request to open the box is rejected.

[0026] This invention supports multiple encryption standards, including AES and SM4 symmetric encryption, for high-strength encryption of transmitted data, combined with authentication and digital signatures. The transshipment box is equipped with a pre-installed authoritative CA certificate and a public-private key pair bound to the box information, authenticated through the CA signature certificate. It employs a combination of asymmetric encryption and symmetric keys, utilizing key exchange protocols including Diffie-Hellman, to ensure that both parties can securely negotiate a shared key for subsequent symmetric encrypted communication. The sender signs the data using their private key, while the receiver verifies it using the corresponding public key. For emergency situations, it supports both remote online and offline authorization modes; online authorization is achieved through encryption. The system issues signed instructions via communication channels, and offline authorization uses multi-factor authentication codes and authorization codes generated in the background. Once the network connection is restored, it synchronizes the offline operation records to the central monitoring system and generates a detailed event report. It obtains the current location of the positioning device and provides information resources and basic services to the positioning device via the mobile internet. First, it determines whether the transport route of the medicine transport box deviates from the preset route. Second, based on the current location of the transport box, it determines whether the monitored medicine transport box is within the preset allowed electronic fence. If it is not within this electronic fence, the on-site operator's request to open the box is rejected. Therefore, it can ensure real-time regional monitoring, box opening permission management, and data traceability of medicines during the transport process.

[0027] Preferably, the transfer box adopts a double-layer reinforced structure, with the outer layer made of high-strength alloy and the inner layer made of impact-resistant plastic. A modular temperature control unit is installed inside the box.

[0028] Preferably, the electronic lock has fingerprint recognition or facial recognition as a secondary verification method, and the communication between the electronic lock and the control unit adopts an advanced encryption standard.

[0029] Preferably, the sensor network inside the enclosure adopts a redundant design to ensure accurate monitoring of the drug status even when a sensor fails; sensor data is analyzed in real time, and an alarm will be issued once an anomaly is detected; all abnormal events are recorded in detail and tracked and analyzed through generated reports.

[0030] Preferably, the transport box is equipped with a global positioning system and a Beidou navigation system; the transport box has a built-in rechargeable battery, an intelligent power management module, and a low battery warning module.

[0031] Preferably, the control unit further includes a data recording module, which uses blockchain technology to store control commands, enclosure status, and abnormal event data on a private blockchain.

[0032] like Figure 1 As shown, a method for operating an intelligent monitoring drug transport box for drug clinical trial needs is also provided, which includes the following steps:

[0033] (1) Data transmission supports multiple encryption standards including AES and SM4 symmetric encryption to encrypt transmitted data with high strength, combined with identity verification and digital signature; the transshipment box is equipped with a pre-installed authoritative CA certificate and a public-private key pair bound to the transshipment box information, and is authenticated through CA signature certificate;

[0034] (2) Encrypted communication employs a combination of asymmetric encryption and symmetric key encryption, utilizing methods including...

[0035] The Diffie-Hellman key exchange protocol ensures that the two parties in a session securely negotiate a shared key for subsequent symmetric encrypted communication; the sender uses the private key to sign the data, while the receiver uses the corresponding public key to verify it.

[0036] (3) Temporary unpacking authorization: In case of emergency, it supports two modes: remote online authorization and offline authorization. Online authorization is issued through encrypted communication channels with signed instructions, while offline authorization is issued through multi-factor authentication code and authorization code generated in the background. Once the network connection is restored, it will synchronize the operation records during the offline period to the central monitoring system and generate a detailed event report.

[0037] (4) Location-based services: obtain the current location of the positioning device and provide information resources and basic services to the positioning device through the mobile Internet; first, determine whether the transfer route of the medicine transfer box deviates from the preset route; second, determine whether the supervised medicine transfer box is within the preset electronic fence that can be opened based on the current location of the transfer box; if it is not within the electronic fence, refuse the on-site operator's request to open the box.

[0038] Preferably, in step (1), the transit box first generates a public-private key pair, where the private key is used for signing and decryption, and the public key is used for verifying the signature and encryption; the generated public key is bound to the transit box information or certificate for subsequent authentication and public key exchange; after generating the public-private key pair, the transit box obtains the CA's signature certificate, including the following sub-steps:

[0039] (1.1) The transfer box sends the generated public key and its own identity information to the CA authority;

[0040] (1.2) After receiving this information, the CA agency verifies the identity information of the transit container;

[0041] (1.3) If the identity information of the transit box is verified, the CA authority uses its own private key to sign the public key of the transit box and generate a certificate containing the public key of the transit box, the identity information and the CA signature. This certificate is the CA signature certificate of the transit box.

[0042] (1.4) The CA sends the signing certificate to the forwarding box. After receiving the certificate, the forwarding box...

[0043] Store it for later use.

[0044] Preferably, in step (3),

[0045] In the remote online authorization mode, a remote unpacking command containing the signature of the backend system is first generated and sent through a secure communication channel. The signature is formed by encrypting the content of the command. After receiving the command, the control unit verifies the signature. After the signature verification is successful, the unpacking operation is executed.

[0046] Offline authorization includes the following steps: starting offline authorization mode, generating a multi-factor authentication code, transmitting the multi-factor authentication code, the backend system verifying and generating an offline authorization code, entering the offline authorization code, and verifying and opening the transit box.

[0047] Preferably, in step (4),

[0048] By employing the BeiDou positioning method, the real-time location of the medicine transport box is accurately captured. This real-time location data is intelligently compared with the pre-set transport route to detect route deviations. Once it is found that the transport box's travel path does not match the predetermined route, an alarm mechanism is triggered, and a route deviation warning is immediately sent to the monitoring center and relevant management personnel. All historical trajectory information of the transport box is stored.

[0049] When the on-site operator initiates the opening command, the current location information is first detected and compared with the preset electronic fence coordinates. If it is found that the location of the transport box is not within the set electronic fence range, the opening request will be rejected. A warning message will be issued immediately, clearly informing the operator that the current status does not meet the opening conditions, and the failed opening attempt and related information will be reported to the central monitoring server.

[0050] During the drug transportation process, the opening time of the drug transport box is strictly controlled by setting a specific time window. The time control logic identifies the current date and time and compares it with the preset time window. Only within the specified time will the opening instruction issued by the on-site operator be accepted. If the operator attempts to open the box at an unspecified time, the request will be rejected and the violation will be recorded and reported.

[0051] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Any simple modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of the present invention shall still fall within the protection scope of the present invention.

Claims

1. An intelligent monitoring drug transport box for clinical trials, characterized by: Its control unit includes: The data transmission security module supports multiple encryption standards, including AES and SM4 symmetric encryption, to encrypt transmitted data with high strength. Combined with identity verification and digital signature, the transshipment box is equipped with a pre-installed authoritative CA certificate and a public-private key pair bound to the transshipment box information, and is authenticated through the CA signature certificate. The encrypted communication module uses a combination of asymmetric encryption and symmetric keys. It utilizes key exchange protocols, including Diffie-Hellman, to ensure that both parties in the session securely negotiate a shared key for subsequent symmetric encrypted communication. The sender uses its private key to sign the data, while the receiver uses the corresponding public key to verify it. The temporary unpacking authorization module supports both remote online and offline authorization modes for emergency situations. Online authorization issues signed instructions through encrypted communication channels, while offline authorization uses multi-factor authentication codes and authorization codes generated in the background. Once the network connection is restored, it will synchronize the operation records during the offline period to the central monitoring system and generate a detailed event report. The location-based service module obtains the current location of the positioning device and provides information resources and basic services to the positioning device via the mobile Internet. First, it determines whether the transfer route of the medicine transfer box deviates from the preset route. Second, based on the current location of the transfer box, it determines whether the supervised medicine transfer box is within the preset electronic fence that can be opened. If it is not within this electronic fence, the on-site operator's request to open the box is rejected.

2. The intelligent monitoring drug transport box for clinical trials as described in claim 1, characterized in that: The transport box has a double-layer reinforced structure. The outer layer is made of high-strength alloy, and the inner layer is made of impact-resistant plastic. The box is equipped with a modular temperature control unit.

3. The intelligent monitoring drug transport box for clinical trials as described in claim 2, characterized in that: Electronic locks have fingerprint or facial recognition capabilities as a secondary verification method, and the communication between the electronic lock and the control unit uses advanced encryption standards.

4. The intelligent monitoring drug transport box for clinical trials according to claim 3, characterized in that: The sensor network inside the enclosure is designed with redundancy to ensure accurate monitoring of the drug status even if a sensor fails; sensor data is analyzed in real time, and an alarm will be issued once an anomaly is detected; all abnormal events are recorded in detail and tracked and analyzed through generated reports.

5. The intelligent monitoring drug transport box for clinical trials according to claim 4, characterized in that: The transport box is equipped with a global positioning system and a Beidou navigation system; it also has a built-in rechargeable battery, an intelligent power management module, and a low battery warning module.

6. The intelligent monitoring drug transport box for clinical trials according to claim 5, characterized in that: The control unit also includes a data recording module, which uses blockchain technology to store control commands, enclosure status, and abnormal event data on a private blockchain.

7. A method for operating an intelligent monitoring drug transport box for clinical trials, characterized by: It includes the following steps: (1) Data transmission: It supports multiple encryption standards including AES and SM4 symmetric encryption to encrypt the transmitted data with high strength. Combined with identity verification and digital signature, the transit box is equipped with a pre-installed authoritative CA certificate and a public-private key pair bound to the transit box information. Authentication is performed through the CA signature certificate. (2) Encrypted communication adopts a combination of asymmetric encryption and symmetric key, and uses key exchange protocols including Diffie-Hellman to ensure that the two parties in the session securely negotiate a shared key for subsequent symmetric encrypted communication; the sender uses the private key to sign the data, while the receiver uses the corresponding public key to verify it; (3) Temporary unpacking authorization: In case of emergency, it supports two modes: remote online authorization and offline authorization. Online authorization is issued through encrypted communication channels with signed instructions. Offline authorization is issued through multi-factor authentication code and authorization code generated in the background. Once the network connection is restored, it will synchronize the operation records during the offline period to the central monitoring system and generate a detailed event report. (4) Location-based services: obtain the current location of the positioning device and provide information resources and basic services to the positioning device through the mobile Internet; first, determine whether the transfer route of the medicine transfer box deviates from the preset route; second, determine whether the supervised medicine transfer box is within the preset electronic fence that can be opened based on the current location of the transfer box; if it is not within the electronic fence, refuse the on-site operator's request to open the box.

8. The working method of the intelligent monitoring drug transport box for drug clinical trial needs according to claim 7, characterized in that: In step (1), the transit box first generates a public-private key pair. The private key is used for signing and decryption, and the public key is used for verifying the signature and encryption. The generated public key is bound to the transit box information or certificate for subsequent identity verification and public key exchange. After generating the public-private key pair, the transit box obtains the CA's signature certificate, including the following sub-steps: (1.1) The transfer box sends the generated public key and its own identity information to the CA authority; (1.2) After receiving this information, the CA agency verifies the identity information of the transit container; (1.3) If the identity information of the transit box is verified, the CA authority uses its own private key to sign the public key of the transit box and generate a certificate containing the public key of the transit box, the identity information and the CA signature. This certificate is the CA signature certificate of the transit box. (1.4) The CA sends the signing certificate to the forwarding box, which stores the certificate for future use after receiving it.

9. The working method of the intelligent monitoring drug transport box for drug clinical trial needs according to claim 8, characterized in that: In step (3), In the remote online authorization mode, a remote unpacking command containing the signature of the backend system is first generated and sent through a secure communication channel. The signature is formed by encrypting the content of the command. After receiving the command, the control unit verifies the signature. After the signature verification is successful, the unpacking operation is executed. Offline authorization includes the following steps: starting offline authorization mode, generating a multi-factor authentication code, transmitting the multi-factor authentication code, the backend system verifying and generating an offline authorization code, entering the offline authorization code, and verifying and opening the transit box.

10. The working method of the intelligent monitoring drug transport box for drug clinical trial needs according to claim 9, characterized in that: In step (4), By using the BeiDou positioning method, the real-time location of the medicine transport box is accurately captured. This real-time location data is intelligently compared with the pre-set transport route to detect route deviations. Once it is found that the transport box's travel path does not match the predetermined route, an alarm mechanism is triggered, and a route deviation warning is immediately sent to the monitoring center and relevant management personnel. Store all historical trajectory information of the transshipment box; When the on-site operator initiates the opening command, the current location information is first detected and compared with the preset electronic fence coordinates. If it is found that the location of the transfer box is not within the set electronic fence range, the opening request will be rejected. Immediately issue a warning, clearly informing the operator that the current status does not meet the opening conditions, and report this failed opening attempt and related information to the central monitoring server; During the drug transportation process, the opening time of the drug transport box is strictly controlled by setting a specific time window. The time control logic identifies the current date and time and compares it with the preset time window. Only within the specified time will the opening instruction issued by the on-site operator be accepted. If the operator attempts to open the box at an unspecified time, the request will be rejected and the violation will be recorded and reported.

Images