hypertrust X-Chain

Securing a patient-centered closed-loop supply and distributed data chain for autologous cell therapies

Autologous cell therapies are highly innovative therapeutic approaches in the field of personalized medicine. A safe and seamless interaction of the various participants in the overall process is required to guard the chain of information as well as the chain of custody.

Each process step, as well as the data generated during the 7 process steps, must be consistently and immutably documented and stored while ensuring the authenticity of all process participants to protect the patient and batch data.

However, systems currently used are rather restricted to the needle-to-needle process and do not provide the traceability beyond these steps to enable a full orchestration of the supply chain.

The hypertrust X-Chain solution on blockchain technology enables full orchestration of the closed-loop supply and distributed data chain as well as real-time traceability, notifications and secure exchange between stakeholders.

Process hypertrust X-Chain covers the 7 key steps of a closed-loop supply and data chain

Features hypertrust X-Chain based on blockchain technology offers a wide range of special features for all stakeholders involved in the supply chain

Technology Leveraging blockchain technology with Camelot Hypertrust Platform

Distributed meets highly secure

Camelot Hypertrust Platform combines the most desired features of different qualified blockchain and blockchain-like technologies.

Depending on the requirements of your closed-loop supply chain processes in terms of data integrity, communication channel confidentiality, user authenticity and service availability, it provides a best-of-breed solution stack.

Carefully balancing the pros and cons of e.g. data distribution, storage requirements and confidentiality levels, your products can be managed in the most appropriate way.

 

Why blockchain?

Blockchain technology does have a major impact on the life sciences industry as it allows transferring information and data among various participants in a secure and trusted manner and in a way that ensures integrity of transactions through a consensus mechanism and an immutable storage.

The hypertrust X-Chain solution makes use of blockchain features in suitable areas like e.g. auditability via immutable logs, selective data sharing with untrusted parties while still relying on traditional proven technologies like data bases and cloud computing in its core processes.

Benefits hypertrust X-Chain delivers multiple benefits to all stakeholders of closed loop supply chains

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Effective & cost efficient

Streamlined, easy, agile and secured data sharing through smart contracts across stakeholders with effective data tracking, less paperwork and powerful security measures.

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Powerful monitoring & transparency

Decentralized documentation enhances precision and brings transparency through traceable records of movements and conditions while in addition saving time, costs and efforts.

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Better collaboration

With the help of distributed ledger technology, the Blockchain proactively promotes the active and secure collaboration between involved stakeholders.

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Easy access and usability

The uninterrupted connectivity with level-based authorization greatly empowers the stakeholders. By automating the processes, the blockchain technology helps to extract the maximum potential of manpower throughout the supply chain.

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Protection of crucial data

Equipped with the latest cryptographic features the blockchain technology not only facilitates checking the data authenticity of all involved parties through digital signatures but even more it accelerates to the next level of data security.

Patient

From a patients perspective, fast, successful and safe disease treatment are the most important factors

Challenges Requirements
  • Full orchestration of all stakeholders involved in the process
  • Automated triggering of follow-up activities (e.g. delivery scheduling)
  • Trusted therapy process
  • Full visibility on the chain of custody with tracking according SOPs
  • Continuous flow of the end-to-end process by secured temporary or permanent ownership transfer
  • Cryptographic features secure the reading only by authorized stakeholders
  • Level-based authorization of all involved parties
  • Complete and immutable data exchange which guarantees full compliance of chain of identity & custody
  • Supporting guidelines throughout the entire process

Referrer / Healthcare Professionals

Healthcare Professionals require straightforward usability and a clear overview of the entire process

Challenges Requirements
  • Automation of processes and activities
  • Supporting guidelines throughout the entire process
  • Integration of all stakeholders and external systems
  • Value entry support for every information point
  • Integration of all stakeholders and external systems
  • Alert notifications and four-eye-principle
  • Latest crypto-graphic features facilitates data authenticity check
  • Possibility of secured temporary or permanent ownership transfer
  • Advantages of time saving functionalities
  • Level-based authorization of all involved parties
  • Decentralized storage and log enhances transparency and auditability throughout all process steps

Chief Doctor

The Chief Doctor requires a trustworthy, easy and agile process with limited interruption of day-to-day activities

Challenges Requirements
  • Seamless data transfer supporting the HCP maintaining product relevant data fields
  • No replacement or deletion of data in other systems
  • Value entry support for every information point
  • Integration of all stakeholders and their data contribution
  • Automation of time-saving processes and activities
  • Direct trigger of planning and scheduling activities at the PharmaCo site
  • Automated scheduling of pick-up and delivery to streamline patient process
  • Latest cryptographic features facilitate checking the integrity of all entered data and the reliability of it’s sources
  • Possibility of secured temporary or permanent ownership transfer

Clinic

For clinics, the system should be easily integrated, straightforward to use and able to trace the chain of identity and custody

Challenges Requirements
  • Real-time tracking & tracing providing a fully immutable audit trail from end-to-end
  • Full visibility on chain of identity and custody along the supply chain
  • Integrate with any clinic system if requested
  • No requirement to install any further application, etc. – Lowest impact on current IT setup
  • No additional costs
  • More secured, agile and flexible process for the patient
  • Full visibility of the product treatment and handling (exclude quality reduction)
  • Orchestration of all involved stakeholders
  • Distributed ledger technology proactively promotes the active and secure collaboration between involved stakeholders

PharmaCo

PharmaCo companies require an easy to use solution which enables an improved handling of the overall complex and time-critical process

Challenges Requirements
  • Secured correct handling and compliance
  • Ability to track treatment impact on anonymous patient / case level
  • Trustworthy and reliable exchange between stakeholders
  • Real-time tracking and alerting for any issues that could cause stop or abortion of manufacturing process
  • Supported identification of issue & predictive intervention
  • Simple selection of product and prescription to reduce any barrier for the HCPs
  • Related processes/ data supported with easy-to-use and time saving platform
  • Ability to monitor all relevant data in time and take actions, if needed
  • Possibility to report in a timely manner required data to the authorities after access request to all stakeholders

Qualified Person

Each treatment needs to be released separately by the Qualified Person

Challenges Requirements
  • Data along the supply chain loop is saved and with minimal resources transferred from the QS system to the platform
  • Auditability: Hash of QM document is immutably stored on the platform
  • Centralized access to decentralized stored information and data
  • Integration of all required information / documents from other external systems
  • Reliable automated check regarding completeness and correctness of information
  • Upfront alerts for missing data. Automated request for data before release process
  • Proactive and predictive alerts throughout the process, e.g. detection of lab failures, and automated counteraction recommendations (e.g. re-sampling, re-qualify)

IT Head

PharmaCo IT Head especially requires a seamless integration to existing systems with minimal implementation effort

Challenges Requirements
  • Seamless integration of other hospital systems without direct impact on their functionality if requested
  • No replacement or deletion of data in other systems
  • Flexibility to integrate with any client system and application
  • Time-saving cloud provisioning model
  • Blockchain advantages without the implementation overhead
  • Authenticity guaranteed through blockchain technology
  • High data privacy level through encryption concepts
  • Additionally protected by blockchain based access control
  • No maintenance effort due to cloud provisioning model
  • Additionally on premise deploy-ment model
  • Profound distributed application lifecycle management mechanism in place

Logistics Service Provider

Logistic Service Providers require a system that enables secure global collaboration and communication as well as transparency

Challenges Requirements
  • Transparency about the quality of transport execution
  • Verifiability of all services provided
  • Detecting bad performance and fraud
  • Forwarder simply can post data to the platform, while the platform is caring about encryption and authorizations
  • The communication is logged audit-proof
  • Easier finding of trustworthy collaboration partners
  • Secure validation of the partner performance
  • Level-based authorization of all involved parties
  • Decentralized storage and log enhances transparency and auditability throughout all process steps
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