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Critical supply chain management for Cell, Gene and Immunotherapies

There are few other fields of medicine that require the level of mass customisation of production and careful orchestration of production pathways that Cell, Gene and Immunotherapies demand. A critical factor facing the industry is choosing technologies and partners that can deliver scale.  

From sample collection through logistics, manufacturing and final treatment, TrakCel's proven technology integrates and orchestrates every aspect of the Clinical program with comprehensive chain of custody, chain of identity and traceability throughout.

TrakCel

Intelligently manage chain of custody, chain of identity
and traceability to clinical standards

Integrate people and processes

Integrate people and  processes across the supply chain for greater efficiency, lower cost, traceability, chain of custody  and chain of identity.

Automate SOPs and
manage workflows

Ensure that every activity is performed to  specification. TrakCel's control of processes informs compliance, accountability and operational efficiency.

Address evolving
Regulatory demands

Design compliance into the supply chain and manage change over time. Reduce risk and costs with a flexible system for handling evolving regulatory demands.

Needle-to-Needle Visibility

Comprehensive

TrakCel provides comprehensive visibility spanning your entire clinical program - from starting material collection at the medical centre, through logistics, storage, manufacturing and final delivery of the drug product to the patient.

Easily accessible

Every supply chain activity and quality event is monitored and  recorded in real-time. No more leafing through stacks of paper, spreadsheets and disparate data files and no risk of data loss or integrity issues.

Digital Chain of Custody

Chain of custody can span multiple data systems, often aided by paper-based processes at clinical sites. This disparate set of elements results in additional data entry and transcription errors and has historically proven difficult to reconcile when required.

TrakCel digitally records and documents when, where and by whom every sample was handled as it happens - throughout every patient's life-cycle.

Chain of Identity

Data management overhead in clinical studies,  often compounded by the high turnaround rate of clinical research associates and monitors, can lead to data gaps and unanswered questions. In such cases, you may not be in a position to provide answers to vital questions regarding your study.

By deploying TrakCel's workflow based orchestration technology, such costly gaps and risks can be significantly reduced or removed altogether.

Consistent Execution

Each personalised cell therapy product ultimately depends on a sustainable and consistent set of processes. There are many disparate moving parts in the end-to-end supply chain and significant related challenges to ensuring reproducible, robust and consistent execution. 

TrakCel's prescriptive clinical workflows, configured exactly in line with your process designs, ensures consistency across all your clinical and manufacturing activities.

Regulatory compliance and validation

Designed to meet FDA, EMA and PIC/S validation requirements

Manage compliance in line with regulatory requirements, with instant access to each patient's electronic audit log.  TrakCel's implicit orchestration, traceability and reporting capabilities allow you to proactively manage and meet quality requirements far more effectively and efficiently than paper-based best efforts.

This is a subset of the regulations and statutory obligations that the TrakCel platform is designed to meet. Additionally we provide support during the requirements gathering and validation project phases. Our experts will perform regulatory reviews and science-based risk assessments to ensure you remain compliant. Our validation processes are based on FDA and PIC/S guidance.

Find out more.

Get in touch today and discover why leading Trial Sponsors, Developers and CMOs are selecting TrakCel to manage their clinical supply chains.

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TrakCel is growing

Grow with us.

We are designing and building the technology platform of the future for personalised healthcare. Join us and help define how life-changing Cell and Gene therapies are delivered at global scale.

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