AI GxP validation for regulated life sciences
Study Intelligence

Study Intelligence

Agentic intelligence across your studies — samples, biomarker data, operations and vendors in one place.

Quick chat on WhatsAppHuman review at every gate
Brings togetherCentral labsSpecialty labsCROsBiorepositoriesEDC exportsCTMS exportsConsent records
Study Intelligence study overview
Part 11 audit trailHash-chained, tamper-evident
Answers with sourcesEvery record cited
Human reviewAt every gate
In short

Study Intelligence brings sample, biomarker, clinical operations and vendor data from every CRO, lab and repository into one governed view of each study. Study agents answer questions in plain English, cite the records behind every answer, and flag what needs attention before it becomes a problem.

Cybroscape is trusted by life sciences teams worldwide

GSK
Karolinska Institutet
Mercy Health
3Analytics
TriDS Validation
Excelra
Ceban Pharmaceuticals
Prothiya
Batavia Biosciences
Codern Pharma
Hexaware
What it does

Every sample, result and site in one view of the study.

A clinical programme spreads its data across many hands: central and specialty labs hold the samples and assay results, CROs hold the site and visit data, biorepositories hold the inventory, and consent sits in yet another system. Study teams spend their week reconciling these sources by spreadsheet. Study Intelligence brings them together, matches samples to subjects, visits and consent, harmonises biomarker data into one model, and keeps study operations visible across vendors. Study agents answer questions like 'which samples are at risk of missing their stability window?' with the records cited, and raise exceptions — a consent withdrawal with samples still in storage, a shipment that never arrived, a visit with no matching sample — as they happen.

Across the whole study

Samples, biomarker data, site and visit operations, and vendor milestones in one view — not samples on their own.

Answers with their sources

Every answer from a study agent cites the records it rests on, so a study manager can check it in one click.

Exceptions before they become findings

Consent, chain of custody, stability windows and missed shipments are checked continuously and raised to the right owner.

Vendor-neutral

Works with the CROs, labs and biorepositories you already use. Data arrives in their formats and is mapped to one model.

Connected to the rest of the work

Study data flows into TraceDraft for clinical documents, and the platform itself is validated with GxP Copilot.

Product tour

See it working.

Inside Study Intelligence — the study overview, sample inventory, study agents and vendor reconciliation.

Study Intelligence study overviewStudy Intelligence sample inventoryStudy Intelligence study agent answering a questionStudy Intelligence vendor reconciliation
Study overviewSamples tracked, received against schedule, and open exceptions.
How it works

From scattered vendor data to one view of the study

Six steps from the first data transfer to oversight across every CRO and lab.

Prepared by Study Intelligence
Checked and approved by your study team, with a full audit trail
Step 1 of 6: ConnectWhat Study Intelligence produces

Manifests, inventories, results and visit data from labs, CROs and biorepositories, in their own formats.

 What your team decides

Your team confirms which vendors and studies are in scope.

Capabilities

The Study Intelligence capability stack

Every capability has its own page, written for search and generative engines alike. Pick one to see how it works.

Sample tracking and inventorySample Intelligence

A master inventory of study samples across labs, CROs and biorepositories, with chain of custody, stability windows and consent status for each one.

Learn more about Sample Intelligence
Biomarker and assay dataBiomarker Data Intelligence

Bring in assay results from any lab, map them to one model, check quality on arrival and keep each result traceable to its original file.

Learn more about Biomarker Data Intelligence
Sites, visits and milestonesStudy Operations Intelligence

Enrolment, visits, sample collection, protocol deviations and vendor milestones in one operational view, tied back to the sample and biomarker data.

Learn more about Study Operations Intelligence
Questions and tasks in plain EnglishStudy Agents

Study agents answer questions about samples, data and operations in plain English, cite the records behind each answer, and prepare routine work for people to approve.

Learn more about Study Agents
Consent, custody and stability checksException Detection

Continuous checks for consent withdrawals with samples still in use, broken chains of custody, stability windows, missed shipments and samples with no matching visit.

Learn more about Exception Detection
CROs, labs and biorepositoriesVendor and Lab Reconciliation

Match manifests, inventories, visit data and results across CROs, central and specialty labs and biorepositories, and send discrepancies back with the evidence.

Learn more about Vendor and Lab Reconciliation
Cohorts and cross-study analysisTranslational Research Workspace

Build cohorts across studies by clinical, sample and biomarker criteria, check consent for the intended use, and hand a clean, traceable dataset to analysis.

Learn more about Translational Research Workspace
Part 11, GDPR and consentCompliance and Consent Controls

Role-based access, tamper-evident audit trail, Part 11 signatures, consent scope carried with every sample, and validation evidence for your intended use.

Learn more about Compliance and Consent Controls
Deep dive

Everything a study operations lead asks before buying

The Reconciliation Problem

On most studies nobody is short of data. The problem is that the same sample appears in four places — the lab's manifest, the CRO's visit record, the biorepository's inventory and the consent log — and each one is a little different. Study teams find out at database lock, or worse, at an audit, that a set of samples has no matching consent or that an assay was run on a sample from a withdrawn subject.

Study Intelligence matches these sources continuously. Each sample is linked to its subject, visit, consent status, location and assay results, and a mismatch is raised when it appears rather than at the end of the study.

See this on your own systemBook a demo, or chat with a validation lead on WhatsApp.

Study Agents: Questions in Plain English

Study managers, sample managers and translational scientists ask questions such as: how many baseline samples have we received from site 104? Which samples are within two weeks of their stability limit? Which subjects have a biomarker result but no matching consent for future research? The study agents answer from the governed data and list the records behind the answer.

The agents can also carry out routine work — draft a shipment reconciliation, prepare a destruction list for withdrawn consent, or summarise a vendor's outstanding items — for a person to review and approve. They do not change source data on their own.

Biomarker Data You Can Use Across Studies

Biomarker results arrive from different labs in different formats, units and naming conventions. Study Intelligence maps them to one model, runs quality checks on arrival and keeps the link back to the original file, so a result can be traced to where it came from.

Because the model is shared, translational teams can look across studies — the same marker, the same assay, different programmes — without rebuilding the data for every question.

Compliance and Data Protection

Study data is regulated data. Access is role-based, every change is captured in a tamper-evident audit trail, and approvals use Part 11 electronic signatures. Consent scope travels with each sample, so use outside the consent is flagged rather than discovered later.

The platform supports GDPR and HIPAA obligations for personal data, and its own validation is carried out with GxP Copilot so you receive the validation evidence for your intended use.

Sources

Primary documents referred to on this page, from their official publishers.

FAQ

Study Intelligence FAQs

The questions we get before every first call, answered plainly. Prefer to talk first? Chat with us on WhatsApp.

What is Study Intelligence?

A platform that brings sample, biomarker, study operations and vendor data from every CRO, lab and biorepository into one governed view of each study, with study agents that answer questions in plain English and cite the records behind every answer.

How is it different from a sample management tool?

It covers samples, but also biomarker results, site and visit operations and vendor milestones, and links them, so you can see that a visit produced no sample or that a result belongs to a subject who withdrew consent.

Do the study agents change our data?

No. They answer questions and prepare work such as reconciliations and destruction lists for a person to review. Any change to a record needs a person's approval, recorded in the audit trail.

Which vendors does it work with?

It is vendor-neutral. Central and specialty labs, CROs and biorepositories send data in the formats they already use, and it is mapped to one model during onboarding.

How is study data protected?

Role-based access by study, a tamper-evident audit trail, Part 11 signatures for approvals, consent scope enforced on every use, and support for GDPR and HIPAA obligations.

See Study Intelligence run on your own data.

Bring a study's sample manifest or vendor data. We show you the reconciled view and the questions it answers.

  • We reply within one business day
  • We walk through a study like yours
  • You see answers with their sources

Book a demo

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