Regulated study data, handled as regulated data.
Role-based access, tamper-evident audit trail, Part 11 signatures, consent scope carried with every sample, and validation evidence for your intended use.
Study Intelligence controls access by role and study, records every change in a tamper-evident audit trail, uses Part 11 electronic signatures for approvals, carries consent scope with every sample so out-of-scope use is flagged, and supports GDPR and HIPAA obligations. Validation evidence for your intended use is produced with GxP Copilot.
Consent and access as afterthoughts
When consent and access rules live outside the data, they are checked occasionally and by hand. That is where privacy and consent findings come from.
Rules that travel with the data
Consent scope and access rules are attached to the data itself, so every query, cohort and export respects them, and attempts to go beyond them are recorded.
What you get
What Compliance and Consent Controls delivers
Compliance and Consent Controls is part of the Study Intelligence platform — an AI-native, study intelligence system built for regulated Life Sciences. See how it fits with Sample Intelligence, Biomarker Data Intelligence, Study Operations Intelligence.
- Role-based access by study
- Tamper-evident audit trail
- Part 11 electronic signatures for approvals
- Consent scope enforced per sample
Common questions
Prefer to talk first? Chat with us on WhatsApp or book a call with an expert.
Is the platform validated?
We validate the platform with GxP Copilot and provide the evidence package. Your validated state still depends on your intended use and configuration, which we support as part of onboarding.
Related capabilities
All capabilitiesA 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 IntelligenceBiomarker Data IntelligenceBring 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 IntelligenceStudy Operations IntelligenceEnrolment, 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 IntelligenceStudy AgentsStudy 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 AgentsException DetectionContinuous 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 DetectionVendor and Lab ReconciliationMatch 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 ReconciliationSources
Primary documents referred to on this page, from their official publishers.
See compliance and consent controls 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