Our Technology

Designed to deliver cell therapies at commercial scale

Technology overview

Manage every activity, workflow and clinical SOP across your supply chain

TrakWeb ™

Your secure online portal provides instant visibility of the entire end-to-end supply chain from your desktop

ColdTrak™

Monitor cell shipments with real-time reports and alerts worldwide.

TrakZone™

Manage and control access to user and location-specific functionality 

TrakPad ™

Schedule  Activities Clinical SOPs and action workflows and deviations as they happen

TrakFlow™

Configure every workflow and process across the entire supply chain with exacting specification

TrakPad

Standardise every activity across the supply chain

Materials management

Easily scan and identify products, collection kits, supplies, reagents, lab and logistics equipment and more.

Personalised task lists 

Schedule collection notifications and infusion in line with manufacturing capacity, progress  and logistics progress.

Data capture

Integrated online forms capture, validate and record all input saving you time and money and reducing paperwork.

Manage Chain of Custody

Enforce chain of custody sample accountability right across the supply chain with explicit process workflows

Labelling & RFID support

Eliminate the overhead of third-party labelling. TrakPad seamlessly generates and reads labels and ISBT-128 compliant bar codes.

Track Clinical SOPs

Automated delivery and control of SOPs ensures compliance, traceability, accountability and improved operational productivity.

TrakWeb

Instant visibility across the entire supply chain 

Secure
online portal

The secure online portal provides instant visibility of the entire study activity from your desktop,

Manage
multiple studies

Securely manage multiple studies from one login.

Electronic audit
logs

Lock-in compliance with Electronic audit logs Be better prepared to for regulatory inspections.

Data management & Report generation

Every action and event is monitoried and recorded giving you global visibility. 

Performance management

TrakCel automatically monitors critical events and alerts of conditions that need attention.

Quality &
Compliance

Easily report process inputs and outcomes for regulatory bodies 

ColdTrak

Track and report on every patient sample in real-time

Measure

ColdTrak delivers real-time deviation alerts, temperature trends and on-demand logistics information for every cell sample.

Manage

ColdTrak reports allows you to measure and manage Distribution provider SLAs for every single cell shipment.

Deliver

Monitoring your cold-chain shipments in real-time  saves time, money and helps prevent clinical and commercial disasters. 

TrakZones

Track Chain-of-custody and enforce location-specific workflows

Chain of custody

TrakZone tags, either RFID or Barcoded, at facilities, in clean rooms and on lab equipment, ensure explicit chain of custody tracking across the supply chain.

Enforce location

TrakZone tags, allied to username/password authentication, enforces security and location-aware functionality at disparate facilities across the supply chain.

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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