ALCOA+ data expectations
Records are assessed for attributability, legibility, contemporaneity, originality, accuracy and the enduring/available criteria.
Clinical Technology Solutions
Clinical trial technology & sample integrity
Integrated, modular support for cold-chain and environmental monitoring, clinical sample and IMP integrity, equipment lifecycle and service control, and operations intelligence. CliniGA acts as the accountable CRO and quality layer: capability is scoped per project and remains subject to feasibility and technology vendor qualification.
Illustrative study workflow
Clinical research
Modular Capabilities
Four modules, combined only where they are justified
Each module is configured to the protocol, site infrastructure and intended use. Nothing is deployed before requirements, responsibilities and vendor qualification are documented.
Cold chain & environmental monitoring
Monitoring scopes are configured per study and storage unit, then confirmed with the site and the qualified technology partner before use.
- Configurable −20 °C / −80 °C / ambient ranges
- Humidity and relevant environmental events
- Threshold-based alarm and escalation rules
- Scheduled and on-demand monitoring reports
- Traceable, time-stamped records
- Excursion documentation workflow
Sample & IMP chain of custody
Custody evidence requirements are defined by protocol, sample type and transport model, then tested during the pilot.
- Time, location and handover evidence
- Transport-condition records
- Excursion and event visibility
- Offline capture and later synchronisation
- Lane and route requirements assessed in pilot
- Reconciliation against shipment documentation
Equipment, calibration & service control
Lifecycle control builds on CliniGA's existing equipment and calibration service, extended with digital records where scoped.
- Storage mapping and calibration evidence
- Calibration and verification due dates
- Maintenance tickets and service history
- Asset and serial-number register
- Deviation and CAPA linkage where scoped
- Handover and return documentation
Operations & data intelligence
Reporting starts with non-sensitive operational data. AI-supported features remain off by default.
- Operational dashboards and status views
- Workflow automation for routine tasks
- Non-sensitive operational data first
- AI disabled until privacy and security review
- Data-flow and validation review before enablement
- Documented human review of outputs
Integration ecosystem
Review a vendor-specific integration pathway
See how environmental monitoring, laboratory, equipment and operations platforms are separated from CliniGA oversight through qualification, secure interfaces and measurable pilot gates.
Qualification Pathway
Discover → Qualify → Pilot → Validate → Scale
Every stage has an owner, an output and measurable acceptance criteria agreed in advance. Results are reported as observed during the pilot; CliniGA does not publish predicted performance figures.
- Stage 1
Discover
Intended use, regulatory context, sites, sample types and data flows are documented with the sponsor or site.
Output: written intended-use and requirement statement.
- Stage 2
Qualify
Candidate technologies are assessed for supplier maturity, support model, security posture, calibration traceability and documentation.
Output: supplier qualification and risk assessment record.
- Stage 3
Pilot
A limited-scope pilot runs on defined units, lanes or workflows with agreed measurement points.
Acceptance criteria: record completeness, alarm latency, offline capture and recovery, user acceptance.
- Stage 4
Validate
Evidence is reviewed against the intended use, including audit-trail challenge testing and calibration traceability.
Acceptance criteria: audit-trail challenge outcome, calibration traceability, uptime observed during the pilot window.
- Stage 5
Scale
Only criteria that were met are scaled; gaps go back to qualification or remain out of scope.
Output: scale-up decision, change control plan and training package.
GxP Guardrails by Design
Quality expectations are defined before technology is selected
Regulatory applicability is assessed for the intended use and jurisdiction. These activities support alignment, readiness and evaluation; they do not constitute certification or automatically establish compliance with FDA 21 CFR Part 11, EU GMP Annex 11, GCP, GDP or other requirements.
Audit-trail review
Audit-trail content, immutability and review practicality are challenged during the pilot rather than assumed.
Access control & MFA evaluation
Role-based access, joiner/mover/leaver handling and multi-factor authentication options are evaluated per system.
Encryption & data flow
Transport and storage encryption, hosting locations, sub-processors and cross-border transfers are mapped before use.
Backup, restore & continuity
Backup scope, restore testing and continuity arrangements are requested from the supplier and reviewed.
Change control
Configuration, firmware and interface changes are handled through documented change control.
Supplier qualification
Suppliers are qualified for the intended use; qualification status is documented and periodically reviewed.
Computerised system validation readiness
CSV scope is risk-based and defined per intended use. Part 11 and Annex 11 applicability depends on the regulated records, process and jurisdiction; readiness is not certification or compliance.
Where It Fits
Suitable use cases
Sponsors & biotech
Sponsors needing traceable temperature, custody and equipment evidence across multiple sites without owning the technology stack.
Research sites & hospitals
Sites standardising storage monitoring, alarm handling and calibration records ahead of audits or inspections.
Laboratories
Laboratories documenting sample receipt, storage conditions and deviation handling in a consistent, reviewable format.
Biobanks & logistics partners
Long-term storage and transport partners needing event visibility and reconciliation evidence per shipment or lane.
FAQ
Straight answers before you commit
Is this a validated off-the-shelf CliniGA platform?
No. CliniGA does not sell a validated commercial platform here. Modular partner technologies are qualified and piloted for a defined intended use, and CliniGA provides the CRO and quality layer around them.
Does monitoring alone make a process GxP compliant?
No. Monitoring produces data. Compliance depends on procedures, responsibilities, training, deviation and CAPA handling, change control, validation appropriate to the intended use, and documented review of the records.
Can third-party sensors or existing systems be integrated?
Potentially. Integration is possible only after an interface assessment, change-control review and confirmation of calibration and traceability requirements for each device or system.
Can this support international shipping lanes?
It depends on the lane. Country availability, mobile roaming and offline behaviour, airline and battery restrictions, GDPR/KVKK and data-transfer requirements, local support coverage and calibration arrangements are checked before a lane is confirmed.
How does this relate to CliniGA's site equipment service?
The equipment rental and calibration service covers physical equipment and its records. This solution page covers the technology qualification and pilot layer that can sit alongside it when digital monitoring or custody evidence is in scope.
Technology is one part of site readiness
Connect technology, laboratory, pharmacy and team readiness in the protocol-led feasibility pathway.
Start with a scoped pilot discovery
Share the storage units, sample types, lanes or workflows you need evidence for. We will document the intended use, qualification questions and pilot acceptance criteria before any technology is proposed.