TrackREX PK Reconciliation and Sample Tracking

Biosample Reconciliation & sample tracking management tool.
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www.apples-and-oranges.co.uk
© 2018 - 2021
Reconciliation of Biosample data (e.g. PK data)
What PK Reconciliation REALLY involves
THE GOAL
The ultimate goal of PK reconciliation is to ensure resulting data will meet analytical need
THE MISCONCEPTION
“I only have to make sure the sample reference number in the CRF matches the external lab file
report, and my job is done”
THE REALITY
Samples expected per CRF need to be expected in the lab source…simple!
Samples need to match DRAW TIME based upon the protocol (ie, draw time vs
exposure time transcription, with margin of acceptability)
Queries to site must result in correct Exposure timing entries, correct lab draw
entries, and (if collected) aligned CRF vs. lab reference IDs
THE EXTRAS
What if a site keeps on not respecting the protocol expectation?
What if the protocol is too expecting of site staff and needs amending?
© 2018 - 2021
Reconciliation
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01Mar20 14:11 5min post-dose
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01Mar20 15:06
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the NEED
01Mar20 15:06
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90min post-dose
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Exposure Date & Time
01Mar20 14:06
Time from Ingestion
© 2018 - 2021
Sample Tracking
TrackREX will also allow sample tracking:
Streamline manual and labour-intensive
tracking of samples! Use TrackREX to collate
numerous data sources to improve sample
management through the study life cycle
- Track samples from site to laboratories

- Ensure an effective chain of custody exists
- No need for manual and repeated tracking of individual manifests or tracking sheets
- Other systems can be plugged into the tool also, such as CTMS (compare against
enrolment, contract KPIs etc)
© 2018 - 2021
Reconciliation & Sample tracking
How is this possible to achieve in a simple & reproducible way?
With a mapping table and limited data transformed to be ‘TrackREX’ readable,
A&O’s team can set up this pre-made tool relatively quickly compared to other
programming methods. We would need, as a minimum:
- Access to CRF data (or relatively live SDTM)
- Access to lab files (patient, visit, timepoint, sampling timing, not results)
- Client repository (eg, secure sharepoint site)
© 2018 - 2021
How is this possible to achieve in a simple & reproducible way?
Dosing information source Sample information source
Irrespective of data source, by using a system

independent interface (Excel), the tool works
© 2018 - 2021
How is this possible to achieve in a simple & reproducible way, (further details)?
Protocol
CRF Lab File

Exposure
Time & Events (T&Es)
Pat#+SV+EXTPT Pat#+SV+Timepoint+Analyte
=> Unique code => Unique code
MAPPING TABLE
OUTPUT
• Missing samples • Non-respect of T&Es • Protocol violations
• Unentered CRF visits detected • Site performance issues • Permanent issues
• Wrong EX or lab timing • Sample shipment coordination • CLEAN PK DATA!!
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Who benefits?
- Data Management
r i n g
a n b r e
Fast cleaning / oversight of outsourced staff
ti
i s c o e n
- Clinops
h t
T trackingc/ ysite performances
PK sample
c i e n e a m
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- PK Scientists
d y t
Analysis on cleanu
st data / understanding PK schedules in clinical setting
A central tool, no duplication across functions!

© 2018 - 2021
Recommended Use:
- Best use on raw data to have data clean pre-conversion (e.g., to SDTM);
catch issues upstream
- Could either be used as main PK reconciliation tool or used in an
oversight capacity, based on your internal polices
- Could be used as an urgent stop-gap due to poor quality / waiting for
own internal tool development
- Could aid in QC'ing other internal data checks
© 2018 - 2021
Pros:
- Never-ending lightbulb; future systems changes = use of identical tool
- Use on most data sources
- Undercut internal & external programming costs
- Very small set up time ('off the shelf')
- !!NO DOUBLE-DATA REVIEW!! (changed or new data is flagged)
=>No more reconciliation of the reconciliation for the reconciliation of the
prior reconciliation compared to the new reconciliation, etc, etc, etc…
Cons:
- Need individual who is capable at handling study data to set up
- Companies may hinder sufficient access to data sources
© 2018 - 2021
TrackREX can be deployed for the following:
- PD reconciliation
- IK reconciliation
- SAE reconciliation
- Safety lab reconciliation
- Coding consistency tool
ALL will follow the same set-up model.
Contact A&O for any other requirements!
© 2018 - 2021
Reconciliation - exposure vs. sample time
This has the potential for multiple tracking / oversights

tools to feed into a ‘MASTER’ oversight tool:
All with the same, familiar, interface no matter the data source.
© 2018 - 2020

TrackREX PK Reconciliation and Sample Tracking

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Biosample Reconciliation & sample tracking management tool.

Time from Ingestion

- Track samples from site to laboratories

- Access to CRF data (or relatively live SDTM)

- Client repository (eg, secure sharepoint site)

Irrespective of data source, by using a system

CRF Lab File

A central tool, no duplication across functions!

ALL will follow the same set-up model.

Contact A&O for any other requirements!

This has the potential for multiple tracking / oversights

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