Hypertrust X-Chain for Clinical Trials

Covering the entire closed-loop supply and distributed data chain for cell therapies during clinical trials

We have designed Hypertrust X-Chain platform to enable:

  • Scheduling, managing and securing exchange between stakeholders and events
  • Real-time and flexible orchestration of the closed-loop supply chain workflows
  • Versatile integration into clinic systems like SAP IS-H and i.s.h.med

The solution’s core is the Hypertrust Workchain and targeted treatments. The patented Hypertrust Workchain is an “unbreakable” workflow engine – thanks to the underlying blockchain technology. All involved parties of the closed-loop supply chain contribute their sub-process to the overall end-to-end process of the pharma company – always under full control of the own processes and corresponding data. The flexibility leads to a uniquely wide treatment support matrix, not limited to cancer treatments.

Features Hypertrust X-Chain for clinical trials is a flexible, trustworthy solution that makes it easy to integrate and connect all stakeholders in one system

Technology With the blockchain technology of Camelot Hypertrust Platform, a distributed database meets highly secure data exchange.

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.

By carefully balancing the pros and cons of data distribution, storage requirements and confidentiality levels, for example, your products can be managed in the most appropriate way.

 

Blockchain technology

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

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

The Hypertrust Workchain is an important element of our Hypertrust X-Chain solution. It is a tool that helps to holistically define the manufacturing process of personalized medicines. Hypertrust Workchain provides a standardized notation that can be easily understood by all business stakeholders, and that helps to configure the business process individually. The state-of-the-art graphical editor, which is based on flowchart techniques, allows easy specifying of business processes. It’s simple for the end user to adapt changes in the business process. The whole process is recorded and stored on a blockchain where it’s shared with all involved parties. The complete lifecycle of the Workchain is based on blockchain which makes the whole process secure and trustworthy.

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

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Patient centric approach

Curing diseases with cell and gene therapies is the main objective of Hypertrust X-Chain for clinical trials. To promote trials in the cancer area and make the supply chain process as safe, stable and optimized as possible, the Hypertrust X-Chain solution covers all critical areas.

Logistics Service Provider
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Massive supply chain optimization

Reduction of closed-loop supply chain roundtrip times by 30%.

Trust without Middle Man
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Enterprise and GxP grade solution

Hypertrust X-Chain for clinical trials based on Camelot Cloud Platform is a GxP grade solution, FDA 21 CRF Part 11 compliant and end-to-end pharma validation ready.

Patients

Challenges Requirements
  • Full orchestration of all stakeholders involved in the process, a well-structured process with a schedule for the patient, a trusted theraphy process
  • Higher chance of participation because of a well-organized process and more efficiency

Hospitals/Clinics

For Hospitals/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
  • Fully visible 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 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
  • Ease of service provision

Special LSP

Special Logistics Service Providers (cold-chain) 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 can simply post data to the platform, while the platform takes care of encryption and authorizations
  • The communication is logged audit-proof
  • Easier to find trustworthy collaboration partners
  • Secure validation of partner performance
  • Level-based authorization of all involved parties
  • Decentralized storage and log enhances transparency and auditability throughout all process steps
  • Easy & flexible integration of services into the distributed manufacturing process

Specialized CMOs

Challenges Requirements
  • Smart contracts provide an automatic contract process
  • Decentralized storage and log enhances transparency and auditability throughout all process steps
  • Provide workflow platform which allows participating parties to remain in control
  • Seamlessly integrated platform on existing system to ensure a connection between all parties

PharmCos

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

 

Challenges Requirements
  • Real-time tracking and alerting for any issues that could cause stop or abortion of manufacturing process
  • Supported identification of issue & predictive intervention
  • Secured correct handling and compliance
  • 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 required data to the authorities in a timely manner after access request to all stakeholders
  • Ability to track treatment impact on anonymous patient / case level
  • Provide workflow platform that allows participating parties to remain in control
  • Trustworthy and reliable exchange between stakeholders
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