Solution overview

A uniquely comprehensive clinical supply chain management platform

Scale with confidence

Defining your path to scaled production

With TrakCel’s detailed processes and managed workflows for every participant in the value chain, you can safely and efficiently scale outwards and upwards with confidence,

  • Ease scaling challenges with electronic workflow and SOP monitoring 

  • Sample and collection and logistics integration

  • Integrated bar-code, labelling and RFID support

  • Real-time temperature reports includes temperature and location 

Conditional logic workflows for all participants including clinicians, logistics and manufacturing partners ensure standardisation and compliance for each of your therapy's approved procedures.

  • Conditional logic workflows

  • Integrated alerts and notifications

  • Enforce site and location-based activities with TrakZones

  • Integrate and manage supply chain partners

Applications across the cell therapy supply chain

TrakCel's process-based design and configuration means you can design complete coverage for any user, partner, process or event right across the cell therapy supply chain.  This extensible approach allows you to implement and standardise every process, in any order, and at any time and unify your supply chain visibility and reporting.

Therapy Owner
Therapy Owners and Trial Sponsors and Licence holders can design, integrate and report on the entire global supply chain with exacting detail.

Distribution
& Logistics
Reduce distribution and logistics risk with real-time monitoring of shipping including excursion reporting and real-time alerting.

Manufacturing
Configurable workflows, scheduling notifications and inventory management are some of the many features that enable manufacturers to retain control of the production processes during scale up.

Medical Centre
TrakCel has everything that Medical Centre professionals need to capture and record data, schedule collections notifications, generate labels and  schedule treatment notifications.

Easily adapt to changing requirements

TrakCel's modular approach allows you to implement any Function, Process,  SOP  or workflow,
in any order, and at any time  in line with your changing requirements

Medical Centre

TrakCel has everything that the Medical needs need to record essential data, SOP activity and deviations, track inventory, generate and print ISBT-128 bar codes, shipping and other labels. TrakCel can automatically  notify logistics provider,  CMOs and  schedule follow-up patient visits.

Patient Biometrics & Photo Capture

Capture and record essential patient data with optional safety features including photo capture and patient biometrics.

Step-by-step Clinical SOPs

Integrated process guides, driven by the process design,  direct clinicians and ensure standardisation as you scale out. 

Conditional workflows 

Create workflows with conditional logic to ensure that your users perform and stay compliant with MAA approved procedures. 

Inventory and asset tracking

Identify and track products, collection kits, supplies, reagents, lab and logistics equipment and more.

Collection Kits and Consumables

Schedule delivery notifications of Collection kits and consumables in line with treatment needs.

Barcode and label creation

Create and print ISBT 128-compliant and site-specific bar code labels and supports  read / write of RFID labels.

Automated Supply Chain Notifications 

TrakCel generates automated notifications to  supply chain partners to align their resources as needed. E.g logistics, manufacturers.

Deviation Management 

As each process step is progressed, TrakCel records all updates and transactions centrally for real-time reporting.

Distribution & Logistics

TrakCel has comprehensive temperature-sensitive logistics capability to allow automated management of shipment notifications, shipping and logistics information, real-time temperature excursion reporting and location tracking This advanced functionality reduces risk and resource overhead.

Automated Collection Notifications

Automated notifications from supply chain partners including Clinicians and Manufacturers allow alignment of resources.

Real-time temperature reports

Real-time temperature monitors capture and report in-transit temperature data.

Tamper Alerts

Integrated light and humidity sensors can detect when a shipment is opened in transit or a route deviation occurs and report immediately.

Automated Labelling

Automated label generation, based on pre-configured data, at the Medical centre and Manufacturer save time and ensure consistency.

Real-time location reports

Real-time location tracking monitors capture and report in-transit locations worldwide.

Geo-fence notifications 

TrakCel can automatically update supply chain service partners when shipments reach pre-defined locations.

Manufacturing

Configurable workflows, equipment management, ISBT-128 barcode and label generation  and inventory management are some of the many features that enable manufacturers to take control of their processes.  Production processes, designed to mirror the therapy’s MAA, enable standardisation and  compliance during scale up. 

Conditional workflows 

Create workflows with conditional logic to ensure that your users perform and stay compliant within product’s approved process.

Step-by-step Manufacturing SOPs

Integrated process guides, driven by the process design,  direct clinicians and ensure standardisation as you scale out. 

Inventory & Asset Management

Identify and track products, collection kits, supplies, reagents, lab and logistics equipment and more.

Electronic document generation

Perform document and record reviews electronically, including processing data, supplies, reagent consumption and more.

Deviation Management

Schedule sample collection and infusion notifications in line with inventory, staff availability and clean room capacity.

JIT Labelling and Barcoding

Create and print ISBT 128-compliant and site-specific bar code labels and supports  read / write of RFID labels.

Notifications to service partners

TrakCel generates automated notifications to  supply chain partners to align their resources as needed. 

Hardware Interfacing

Automate the integration of data collected by manufacturing equipment into the TrakCel system, saving time and reducing errors. 

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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