1. No category

Visibility. Control. Scale.
A paradigm shift in cell therapy supply chain management
www.trakcel.com
De-risk your cell therapy supply chain
Scale with confidence
TrakCel™ integrates your cell therapy supply chain to
give you needle-to-needle visibility, traceability and
absolute quality control.
Powerful technology that manages process
participants and gives you immediate access to cell
therapy trial data is finally here.
Now you can avoid the risks of paper-based supply
chain management and efficiently scale up and scale
out from clinical trial through to full commercialisation
of your cell therapy.
Discover the Integrated Supply Chain
TrakCel™ integrates and orchestrates every aspect of the
supply chain to give you visibility, control - and the
confidence to scale up and scale out.
1. Integration
2. Control
3. Visibility
Your cell therapy process is
mapped into TrakFlow to become
the reference source for TrakPads.
From physicians to lab technicians,
key participants in the supply chain
use TrakPads with role-specific
Task Lists .
TrakWeb gives you real-time
visibility of every single action and
event from donor enrolment,
sample collection, cellular starting
material logistics, manufacturing
and treatment.
Cellular material is monitored
during transport.
Data at your fingertips TrakWeb™
The Power of Real-Time Visibility
Whether at the extraction stage, during transportation or
as the sample is being manufactured, the status of each
task is available to see immediately using TrakWeb™.
Visualise the overall progress of a clinical trial, or
drill down into each treatment
See time violations, temperature excursions, route
deviations and process breaches as they happen
Alerts prompt you to intervene and avoid risk to
the patient
Clinical Trial Regulatory Analysis and Reports
With TrakCel™ orchestrating and monitoring your
supply chain you are better prepared to pass regulatory
inspections.
Perform batch record reviews
electronically, including processing
data, supplies and reagent consumption,
equipment and more.
Instantly access the latest data for
requisite Regulatory filings, clinical
trial analysis and RFI completion
documents.
Control every step TrakPad™
TrakPad™ drives role-based workflows for every
member of your supply chain .
Task Lists instruct professionals with
task completion acknowledgements
ensuring no step is omitted or
performed out of sequence.
Confirm chain of custody with
electronic receipt of the sample
including time and date data.
Secure check-in ensures specific
tasks are only provided to the
authorised individual.
Capture and record essential patient data
with optional features including patient
biometrics, scheduling of sample collection,
treatment and follow-up reporting.
Bar-codes and labelling enforces
standardisation to easily identify
and track products, collection
kits, supplies, reagents, lab and
logistics equipment.
Logistics monitoring ColdTrak™
ColdTrak™ has comprehensive logistics capability, with automated
management of shipment notifications, shipping and logistics
information, real-time temperature excursion reporting and location
tracking.
TrakCel can automatically update supply
chain service partners when shipments
reach pre-defined locations
Real-time temperature monitors capture
and report in-transit temperature data
Integrated light and humidity sensors can
detect when a shipment is opened in transit
or a route deviation occurs and report
immediately
Time
Temperature
Pressure
Shock, Vibration and Motion
Tri-Axis Accelerometer
Battery level reported over the air (OTA)
GPS location monitoring worldwide
Features that go beyond paper
From the patient to the manufacturer, TrakCel™ is packed with
advantages to ensure your cell therapy is delivered exactly as
designed - with all the data you need to move forward.
Medical Centre
Capture and record essential patient
data
Schedule sample collection and
infusion in line with manufacturing
capacity and logistics progress
Easily scale to other medical centres
using TrakCel technology
Cell Therapy Manufacturer
Trial Data Analysis
Workflows with conditional logic
ensure that operatives stay
compliant with regulatory approved
procedures
Perform document reviews
electronically, including processing
data, supplies and reagent
consumption
ISBT 128-compliant and site-specific
bar code labels and RFID labels ensure
all apparatus is recorded
Automatically collect data from
manufacturing equipment saving time
and reducing errors
Getting started
It’s easy to get started. Our team of supply chain experts and
support staff will partner with you from consultation to
completion.
Solution Design
Every aspect of your cell therapy process is mapped into
the TrakCel™ system, ready for use by the supply chain.
Our experts perform regulatory reviews and risk
assessments to ensure you remain compliant.
System installation

We install, configure , commission and validate the
system with continuous support from consultation
through to the go-live stage.
Technical integration
TrakCel™ is integrated with your current IT systems
for seamless data access.
Training
Our instructional programs provide you and your supply
chain partners with in-depth, hands-on training that
ensures everyone realises the full benefits of TrakCel™.
Good Manufacturing Practice (GMP)
- FDA 21 CFR Part 11 (and predicate rules)
- EudraLex Volume 4 Annex 11
- EudraLex Volume 4 Chapter 4
EU Tissue and Cells Directives
- Directive 2004/23/EC
- Directive 2006/17/EC
- Directive 2006/86/EC

Good Clinical Practice
– MHRA Good Clinical Practice Guide

PII (Personally Identifiable Information)
– HIPAA - Health Insurance Portability and
Accountability Act

Scale with confidence.
Scale safely.
Finally there’s a 21st Century solution to help
commercialise a cell therapy efficiently, successfully and
with minimum risk.
Now you can have full control of your cell therapy process
in clinical trials - and visibility of trial data as it happens.
If you’d like to know how TrakCel™ can help you can scale
up and scale out with confidence just contact us on
[email protected].
Visibility. Control. Scale.
www.trakcel.com
10/11 Raleigh Walk
Brigantine Place
Waterfront 2000
Cardiff, UK
CF10 4LN
www.trakcel.com
Copyright 2015 TrakCel Ltd. All rights reserved.
TR-104-01-01