Biosample Tracking · Translational Medicine

The right bio-sample, sent for assay at the right moment

Specialty assays often run only once a patient meets stratified criteria, such as an exceptional responder or non-responder. Our sample recommendation engine applies those cohort criteria routinely across visits and tells you exactly which bio-samples to send to specialty labs, so no biomarker is missed.

Tracking manifests + EDC + biomarker database  ·  Results integrated back into EDC end-points
PCX-204 · sample recommendation ENGINE
Cohort: exceptional responders
criteria re-applied each visit · biomarker coverage
Patient · criteriaBiomarkerAction
PT-012
Responder · V4 met
MISSING Send aliquot
PT-031
Responder · V3 met
OBTAINED Integrated
PT-044
Non-responder · V4 met
MISSING Pull bio-bank
PT-058
Screening · pending V3
PENDING Monitor
! 2 samples flagged for assay 0 eligible samples missed
Recommendation
Assay PT-012 now
3
Sources reconciled: manifests, EDC, biomarker database
Routine
Cohort criteria re-applied as patients move through visits
ASAP
Samples that should be assayed are surfaced as early as possible
→ EDC
Resultant assay data integrated into EDC end-points
The problem it solves

Never miss a sample that should be assayed

Translational medicine calls for certain cohorts of subjects or patients to have their biomarkers measured. Knowing which samples to assay, and when, is a moving target as patients progress, and a missed window can mean a lost insight.

Criteria-driven, not calendar-driven

Specialty assays run when patients meet criteria, such as exceptional responders or non-responders. Those stratified criteria are applied routinely as patients go through their visits.

Knows what you have, and what is missing

The engine identifies which patients’ biomarkers have already been obtained and which are still missing, so the gap is always visible.

New or bio-banked samples

It directs new bio-samples or bio-banked samples to specialty labs for the assays that need to be performed, drawing on the right vial at the right time.

Closed loop

Assayed early, integrated back

Samples that should be assayed are identified as soon as possible, and the resultant data is integrated into the EDC end-points for analysis.

Identify
Eligible samples surfaced as patients qualify
Integrate
Assay results flow back to EDC end-points
The recommendation engine

Three sources, one recommendation

1

Tracking manifests

All available shipment and chain-of-custody manifests, so the engine knows where every sample is and what is in each vial.

2

EDC data

The EDC, which usually records any bio-samples taken, including patient, visit, date/time and aliquot references.

3

Biomarker database

The biomarker results already obtained, used to tell exactly which patients’ biomarkers are present and which are missing.

What the engine returns

By reconciling all three against the stratified cohort criteria, the module makes sure no eligible sample is overlooked.

Patients newly meeting cohort criteria
Biomarkers obtained vs. still missing
Samples to send: new draw or bio-bank pull
Results routed back to EDC end-points
Sample management & tracking

How samples and data flow into Xbiom

Physical samples move from site to lab to biobank to assay, while the identifiers, manifests, availability and results converge in Xbiom SaaS.

Sample management & tracking — data flow Sample Management and Tracking data flow: samples move from Hospitals and EDC through Central Lab, Biobanks and the Biomarker Lab/CRO, while sample manifests, availability, vial status and assay data integrate into Xbiom SaaS
How it works

From cohort criteria to integrated result

01

Apply criteria

Stratified cohort criteria are applied routinely as patients go through their visits, flagging responders and non-responders.

02

Reconcile coverage

Manifests, EDC and the biomarker database are reconciled to see which biomarkers are obtained and which are missing.

03

Recommend samples

The engine recommends which new or bio-banked samples to send to specialty labs for the assays that should be performed.

04

Integrate results

Resultant assay data is integrated into the EDC end-points, closing the loop for analysis.

Part of Xbiom™

Biosample tracking, built into translational monitoring

The sample recommendation engine runs on Xbiom™, alongside interim clinical monitoring and biomarker integration, so the samples you assay and the data you analyze stay in one connected environment, supported by our Data Concierge team.

Specialty & translational assays Manifest reconciliation EDC integration
Sample coveragelive
Obtained biomarkers tracked
Missing biomarkers flagged
Vial status & availability
Recommended assays queued
FAQ

Biosample tracking, answered

What does the biosample tracking module do?+
It makes sure bio-samples that should be assayed for specialty or translational assays are identified as soon as possible, and that the resultant data is integrated back into the EDC end-points. It is driven by a sample recommendation engine that applies stratified cohort criteria routinely as patients progress through their visits.
When are specialty assays triggered?+
Specialty assays are typically performed once certain patients meet certain criteria, such as exceptional responders or non-responders. The stratified cohort criteria are applied routinely so that, as patients qualify, their new or bio-banked bio-samples can be sent to specialty labs.
What data does the recommendation engine use?+
The engine uses all the available tracking manifests, the EDC data that usually records any bio-samples taken, and the biomarker database. Together these identify which patients’ biomarkers have been obtained and which are missing.
Does it work with bio-banked samples?+
Yes. The engine recommends sending either new bio-samples or bio-banked bio-samples to specialty labs, depending on what is available and what is needed to fill the missing biomarker data.
How do the assay results get back into the study data?+
Once the specialty assays are performed, the resultant data is integrated into the EDC end-points, so the biomarker results sit alongside the clinical end-points for analysis on Xbiom™.

Stop missing the samples that matter most

Apply your cohort criteria continuously, reconcile manifests, EDC and biomarker data, and send the right bio-samples for specialty assays on time. See biosample tracking on Xbiom™.