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Streamline your cell, gene and immunotherapy workflows

TrakCel’s cell orchestration platform (COP) is a unique software solution that facilitates efficiency in cell and gene therapy development by providing a platform by which program-critical information can be collated, tracked, and documented. This means users can avoid the time, cost, and risks associated
with outdated paper-based systems.

Our COP software is a simple and efficient way of providing users with real-time information relating to every step of the cell and gene therapy process, from treatment development, manufacturing, to final delivery. This needle-to-needle approach enables faster decision making and process optimization, and can provide personnel within the chain with actionable data – sending real-time updates to stakeholders.

TrakCel is the only provider of fully integrated software that allows for the comprehensive management and tracking of the many stages of cell and gene therapy programmes, and allows users to prepare comprehensive regulatory audits with less stress. COP is helping customers to hugely reduce the time and costs associated with developing life-changing therapies.

TrakCel’s Cell Orchestration Platform

Enable integration and deliver better results, faster.

Full Integration

Assimilate people and tasks for enhanced efficiency, traceability, and cost reduction,
update chain of custody and chain of identity documentation.

Workflow automation

Monitor your SOPs in real time to ensure they are performed to specification.  Take control and ensure compliance and
accountability.

Simplify compliance

Handle evolving regulatory demands and reduce the risks, time and costs associated
with them.

Needle-to-Needle Visibility

Comprehensive

Our COP provides full visibility across the entire clinical program - from starting material  collection, to final drug delivery, it enables users to carefully monitor the process in real-time, to ensure it is delivered efficiently and effectively.

Easily accessible

COP eliminates the need for paper-based management systems, meaning data relating
to all parts of the process is instantly obtainable. You can now monitor the progress of multiple aspects instantaneously thanks to our digital systems.

Streamlined Chain of Custody

Demonstrating chain of custody can be an arduous task. Spanning multiple data systems and often supported by paper-based documentation, this process can be rife with transcription errors, and loss of valuable data can be common.

COP digitally documents the many variables required for chain of custody, including
the location of samples, time at which they were handled and by whom to subvert
these issues.

Modernised Chain of Identity

COP is able to account for some of the difficulties in building a comprehensive chain of identity. Data management overhead in clinical studies coupled with the high turnaround of research associates is common to the process, which can lead to data gaps that can be bridged by the COP’s workflow based orchestration technology.

Tailored Execution

There are variables in any cell therapy development program that must be executed with consistency for an efficient and cost effective delivery.  Due to the large number of disparate moving parts in the end-to-end supply chain and related hurdles that are likely to be unique to different clients, our COP’s clinical workflows can be developed alongside you to enable it to work seamlessly with established process designs.

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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