Connected documentation, quality, and operations. One governed study record.
AQ QMS provides the core controls required to manage document governance, QCvworkflows, training requirements, competency validation, staff compliance monitoring,vand corrective resolution within one connected quality environment. All aligned withvregulatory expectations such as Good Clinical Practice (GCP), UK GDPR, the DatavProtection Act 2018, and inspection standards followed by the MHRA and research sponsors.
Built to be holistic across documentation, operations, and quality.
AQ’s single study-scoped data model spans eTMF, eISF, ePSF, QMS, CAPA, and DOA – with
no inter-module data synchronisation or document transfer.
Document Control & Governance
Study files built to ICH-GCP E6(R3) structure from day one. Version control, review routing, electronic signatures, and an immutable audit trail — maintained as documents are filed, not assembled the week before a monitoring visit.
- File structures built from ICH-GCP essential document templates
- Version control with immutable revision history
- Full version control with immutable revision history
- Electronic signatures (21 CFR Part 11, EU Annex 11)
- OCR-based indexing & full-text search
- Automatic duplicate detection
Study Operations &
Tracking
Study setup, participant management, visit scheduling, and task tracking — connected to documentation and delegation from the day a site is activated. Operational status visible without chasing across systems.
- Study setup with configurable parameters
- Participant enrolment and visit scheduling
- Task management with planned vs actual tracking
- Study milestone tracking
- Operational dashboards across active studies
Quality &
Compliance
SOPs, training records, deviations, and CAPAs — managed inside the same environment as your study documentation. Not a separate quality system. Quality governance connected directly to the studies and staff it belongs to.
- SOP document control and approval workflows
- Staff training records linked to active SOPs and delegation
- Deviation and incident logging
- Root cause analysis workflows
- CAPA tracking through to resolution and linked evidence
- Full audit trail across quality events
Pharmacy &
IP Control
Investigational product accountability from receipt through destruction — connected to participant records, visit data, and study documentation inside the same governed environment. No separate pharmacy log. No reconciliation across systems before a monitoring visit.
- IP receipt logging and batch tracking
- Storage condition monitoring records
- Dispensing records linked to participants and visits
- Inventory tracking and reconciliation
- Return and destruction records with audit linkage
- Role-based pharmacy access controls
Access, Security &
Audit
Role-based access, immutable audit logging, and GDPR-aligned data handling — built for multi-site NHS and sponsor-facing research environments. Every action is attributable. Every record is traceable. Audit-ready as standard.
- Granular study-level permissions
- SSO integration for secure access
- Role-based access with least-privilege controls
- Immutable audit logging across all modules
- GDPR-aligned data handling and PHI separation
- MHRA-aligned access governance and evidence controls
Document
Intelligence
Completeness signals, gap detection, and filing suggestions — generated from the study record as documents are filed. Every suggested action is confirmed by the user before anything changes. No automated decisions without researcher control.
- Automated metadata extraction
- Document classification suggestions
- Automated missing document detection
- Completeness signals and gap alerts
- Content-based filing recommendations
- All suggested actions are user-confirmed
eTMF, eISF, and ePSF within one study record.
Unlike conventional platforms that separate eTMF, eISF, and ePSF, AQ maintains all documentation within a unified study environment.
No Separation
Trial master records and investigator site files exist within the same study record, access- controlled by role.
No Forced Transfer
Documents and records do not move between systems. Trial, site, and pharmacy operate within the same environment.
No Reconciliation
Completeness, status, and ownership stay visible across eTMF, eISF, and ePSF without cross-checking records.
No Fragmented Audit
All document activity, approvals, and updates sit within a single audit structure across trial, site, and pharmacy.
How AQ compares against other clinical software.
Comparing AQ against top eISF/eTMF platforms based on document governance, site file
management, sponsor-site connectivity, and capabilities that matter.
AQ eTMF — Trial Master File
How AQ eTMF compares against the four categories of competitor commonly found in clinical research, based on the TMF Reference Model, completeness and oversight, sponsor and CRO collaboration, and the capabilities that matter to trial leadership.
Capability | AQ Trials | Legacy enterprise | Mid-market modular | Point eRegulatory | Paper & spreadsheets |
DOCUMENT MANAGEMENT CORE | |||||
TMF Reference Model-aligned structure | ✓ | ✓ | ✓ | ✗ | ✗ |
Zone, section, and artifact-level filing | ✓ | ✓ | ✓ | ✗ | ✗ |
Version control with immutable document history | ✓ | ✓ | ✓ | ✓ | ✗ |
Electronic signatures — 21 CFR Part 11 and Annex 11 | ✓ | ✓ | ✓ | ✓ | ✗ |
Bulk upload with auto-classification | ~ | ✓ — AI-assisted, market-leading in category | ✓ | ~ | ✗ |
Duplicate detection using file hash and metadata | ✓ | ✓ | ~ | ~ | ✗ |
OCR-based indexing and full-text search | ~ | ✓ | ✓ | ~ | ✗ |
PDF/A conversion and archival compliance | ✓ | ✓ | ✓ | ~ | ✗ |
Expected document tracking against study-defined lists | ✓ | ✓ | ✓ | ✗ | ✗ |
REGULATORY COMPLIANCE | |||||
21 CFR Part 11 and ICH-GCP compliance | ✓ | ✓ | ✓ | ✓ | ✗ |
EU Annex 11 compliance | ✓ | ✓ | ✓ | ✓ | ✗ |
UK GDPR-aligned data handling and PHI separation | ✓ | ~ | ~ | ~ | ✗ |
Role-based access control with granular permissions | ✓ | ✓ | ✓ | ✓ | ✗ |
Immutable audit trail across all document actions | ✓ | ✓ | ✓ | ✓ | ✗ |
WORM storage enforcement for regulated records | ✓ | ✓ | ~ | ~ | ✗ |
Third-party Part 11 validation documentation | ✓ | ✓ | ✓ | ~ | ✗ |
SPONSOR-SITE CONNECTIVITY | |||||
eTMF and eISF in the same study environment — no bridge | ✓ | ✗ — separate products in suite | ~ — auto-indexing between two systems | ✗ | ✗ |
Site visibility without file transfer or manual routing | ✓ | ~ | ~ | ✗ | ✗ |
Role-based separation of site and sponsor documents | ✓ | ✓ | ~ | ~ | ✗ |
eISF to eTMF auto-indexing | ✓ | ~ | ✓ | ~ | ✗ |
Multi-CRO and multi-sponsor study support | ✓ | ✓ | ✓ | ✗ | ✗ |
Single login across all studies | ✓ | ✓ | ✓ | ~ | ✗ |
PHARMACY DOCUMENTATION | |||||
ePSF — dedicated pharmacy site file module | ✓ | ✗ | ✗ | ✗ | ✗ |
IP dispensing records linked to participant and visit | ✓ | ✗ | ✗ | ✗ | ~ |
Pharmacy records within the same study environment | ✓ | ✗ | ✗ | ✗ | ✗ |
IP reconciliation and destruction records | ✓ | ✗ | ✗ | ✗ | ~ |
ANALYTICS AND REPORTING | |||||
TMF completeness tracking per study and site | ✓ | ✓ | ✓ | ✗ | ✗ |
Document quality scoring per study and site | ✓ | ✓ | ~ | ✗ | ✗ |
Timeliness tracking — filing speed vs benchmarks | ✓ | ✓ | ✓ | ✗ | ✗ |
Inspection readiness scoring | ✓ | ✓ — heritage strength | ✓ | ✗ | ✗ |
AI-assisted gap detection and anomaly signals | ✓ | ✓ — market-leading in category | ~ | ✗ | ✗ |
Custom report builder | ✓ | ✓ | ✓ | ~ | ✗ |
WORKFLOW AND AUTOMATION | |||||
Digital Delegation of Authority — connected to study record | ✓ | ✗ | ✗ | ✗ | ✗ |
Missing document detection and gap alerts | ✓ | ✓ | ✓ | ~ | ✗ |
Approval workflows with status transitions | ✓ | ✓ | ✓ | ✓ | ✗ |
Staff training records linked to study | ✓ | ~ | ~ | ✗ | ✗ |
Automated document routing by type and role | ✓ | ✓ | ✓ | ✓ | ✗ |
AI-assisted document classification | ✓ | ✓ — market-leading in category | ✓ | ~ | ✗ |
ARCHIVE AND RETENTION | |||||
Legal hold — blocks destruction, requires sign-off | ✓ | ✓ | ~ | ✗ | ✗ |
Retention policy with configurable periods | ✓ | ✓ | ✓ | ~ | ✗ |
Inspection-ready archive export with integrity manifest | ✓ | ✓ | ~ | ✗ | ✗ |
25-year retention with tiered storage | ✓ | ✓ | ~ | ✗ | ✗ |
Destruction certificate generated on record | ✓ | ✓ | ~ | ✗ | ✗ |
UK / NHS DEPLOYMENT & ASSURANCE | |||||
UK / EU data residency — data hosted and held in the UK/EU | ✓ | ~ | ~ | ~ | ~ |
UK-based implementation and support team | ✓ | ~ | ~ | ~ | ✗ |
ICH E6(R3) aligned — current Good Clinical Practice revision | ✓ | ✓ | ✓ | ~ | ✗ |
Built for NHS and UK research governance (HRA / MHRA-aligned) | ✓ | ✗ | ✗ | ✗ | ~ |
NHS Data Security & Protection Toolkit (DSPT) | ✓ | ~ | ~ | ✗ | ✗ |
NHS DTAC — Digital Technology Assessment Criteria | ~ — in progress | ~ | ~ | ✗ | ✗ |
ISO 27001 certified | ~ — in progress | ✓ | ✓ | ~ | ✗ |
Cyber Essentials | ✓ | ~ | ~ | ✗ | ✗ |
RESEARCH NETWORK & MULTI-SITE OVERSIGHT | |||||
Hub-and-spoke / coordinating-centre oversight across multiple sites | ✓ | ✓ | ~ | ✗ | ✗ |
Network-level dashboards — status across all sites in one view | ✓ | ✓ | ~ | ✗ | ✗ |
One platform serving sponsor/CRO and site/network perspectives | ✓ | ~ | ~ | ✗ | ✗ |
Designed for NHS research networks (hub-and-spoke model) | ✓ | ✗ | ✗ | ✗ | ✗ |
INTEROPERABILITY & INTEGRATION | |||||
Single sign-on (SSO) across all modules | ✓ | ✓ | ✓ | ✓ | ✗ |
Open API for integration with EDC, CTMS, and institutional systems | ~ — in progress | ✓ | ~ | ~ | ✗ |
EDC / REDCap integration | ~ — in progress | ✓ | ~ | ✗ | ✗ |
PRICING AND DEPLOYMENT | |||||
Mid-market pricing — no enterprise contract required | ✓ | ✗ — enterprise pricing model | ✓ | ✓ | — no software cost |
Modular pricing — pay for what you use | ✓ | ✗ — platform pricing | ~ | ✓ | — N/A |
ePSF, CAPA, and QMS included in platform pricing | ✓ | ✗ | ✗ | ✗ | ✗ |
Rapid deployment without lengthy implementation | ✓ | ✗ — implementation programme | ~ | ~ | — no implementation, but ongoing drag |
AQ eISF — Investigator Site File
How AQ eISF compares against the four categories of competitor commonly found in clinical research, based on document governance, site file management, sponsor-site connectivity, and the capabilities that matter to research teams and sponsors.
Capability | AQ Trials | Legacy enterprise | Mid-market modular | Point eRegulatory | Paper & spreadsheets |
DOCUMENT MANAGEMENT CORE | |||||
Site file structure — ICH-GCP essential documents | ✓ | ✓ | ✓ | ✓ | ~ |
Version control with immutable document history | ✓ | ✓ | ✓ | ✓ | ✗ |
Electronic signatures — 21 CFR Part 11 and Annex 11 | ✓ | ✓ | ✓ | ✓ | ✗ |
Bulk upload with auto-indexing | ~ | ✓ | ✓ | ~ | ✗ |
Configurable auto-naming conventions | ✓ | ✓ | ✓ | ~ | ✗ |
Duplicate detection using file hash and metadata | ✓ | ✓ | ~ | ~ | ✗ |
OCR-based indexing and full-text search | ~ | ✓ | ~ | ~ | ✗ |
PDF/A conversion and archival compliance | ✓ | ✓ | ~ | ~ | ✗ |
Expiry and certification tracking with rule-based alerts | ✓ | ✓ | ✓ | ~ | ✗ |
REGULATORY COMPLIANCE | |||||
21 CFR Part 11 and ICH-GCP compliance | ✓ | ✓ | ✓ | ✓ | ✗ |
EU Annex 11 compliance | ✓ | ✓ | ✓ | ✓ | ✗ |
UK GDPR-aligned data handling and PHI separation | ✓ | ~ | ~ | ~ | ✗ |
Role-based access control with granular permissions | ✓ | ✓ | ✓ | ✓ | ~ |
Immutable audit trail across all document actions | ✓ | ✓ | ✓ | ✓ | ✗ |
WORM storage enforcement for regulated records | ✓ | ✓ | ~ | ~ | ✗ |
Third-party Part 11 validation documentation | ✓ | ✓ | ~ | ~ | ✗ |
SPONSOR-SITE CONNECTIVITY | |||||
eISF and eTMF in the same study environment — no bridge | ✓ | ✗ — separate site and sponsor products | ~ — separate data layers in suite | ✗ | ✗ |
Sponsor visibility without file transfer or manual routing | ✓ | ~ | ~ | ~ | ✗ |
Role-based separation of site and sponsor documents | ✓ | ✓ | ~ | ~ | ✗ |
eISF to eTMF auto-indexing | ✓ | ~ | ✓ | ~ | ✗ |
Sponsor compliance and cross-site dashboards | ✓ | ✓ | ✓ | ~ | ✗ |
Single login across all studies | ✓ | ✓ | ~ | ~ | ✗ |
PHARMACY DOCUMENTATION | |||||
ePSF — dedicated pharmacy site file module | ✓ | ✗ | ✗ | ✗ | ✗ |
IP dispensing records linked to participant and visit | ✓ | ✗ | ✗ | ✗ | ~ |
Pharmacy records within the same study environment | ✓ | ✗ | ✗ | ✗ | ✗ |
IP reconciliation and destruction records | ✓ | ✗ | ✗ | ✗ | ~ |
ANALYTICS AND REPORTING | |||||
TMF completeness tracking per study and site | ✓ | ✓ | ✓ | ✓ | ✗ |
Document quality scoring per study and site | ✓ | ✓ | ~ | ✗ | ✗ |
Timeliness tracking — filing speed vs benchmarks | ✓ | ✓ | ~ | ~ | ✗ |
Inspection readiness scoring | ✓ | ✓ | ✓ | ✓ | ✗ |
AI-assisted gap detection and anomaly signals | ✓ | ✓ | ~ — emerging across category | ✗ | ✗ |
Custom report builder | ~ — in progress | ✓ | ✓ | ~ | ✗ |
WORKFLOW AND AUTOMATION | |||||
Digital Delegation of Authority — connected to study record | ✓ | ✗ | ✗ | ✗ | ✗ |
Missing document detection and gap alerts | ✓ | ✓ | ✓ | ✓ | ✗ |
Approval workflows with status transitions | ✓ | ✓ | ✓ | ✓ | ✗ |
Staff training records linked to site file | ✓ | ✗ | ~ | ✗ | ✗ |
Automated document routing by type and role | ✓ | ✓ | ✓ | ✓ | ✗ |
File plan with milestones and expected document sets | ✓ | ✓ | ✓ | ✓ | ✗ |
ARCHIVE AND RETENTION | |||||
Legal hold — blocks destruction, requires sign-off | ✓ | ✓ | ✗ | ✗ | ✗ |
Retention policy with configurable periods | ✓ | ✓ | ✗ | ✗ | ✗ |
Inspection-ready archive export with integrity manifest | ✓ | ✓ | ✗ | ✗ | ✗ |
25-year retention with tiered storage | ✓ | ✓ | ✗ | ✗ | ✗ |
Destruction certificate generated on record | ✓ | ✓ | ✗ | ✗ | ✗ |
UK / NHS DEPLOYMENT & ASSURANCE | |||||
UK / EU data residency — data hosted and held in the UK/EU | ✓ | ~ | ~ | ~ | ~ |
UK-based implementation and support team | ✓ | ~ | ~ | ~ | ✗ |
ICH E6(R3) aligned — current Good Clinical Practice revision | ✓ | ✓ | ✓ | ~ | ✗ |
Built for NHS and UK research governance (HRA / MHRA-aligned) | ✓ | ✗ | ✗ | ✗ | ~ |
NHS Data Security & Protection Toolkit (DSPT) | ~ — in progress | ~ | ~ | ✗ | ✗ |
NHS DTAC — Digital Technology Assessment Criteria | ~ — in progress | ~ | ~ | ✗ | ✗ |
ISO 27001 certified | ~ — in progress | ✓ | ✓ | ~ | ✗ |
Cyber Essentials Plus | ~ — in progress | ~ | ~ | ✗ | ✗ |
RESEARCH NETWORK & MULTI-SITE OVERSIGHT | |||||
Hub-and-spoke / coordinating-centre oversight across multiple sites | ✓ | ✓ | ~ | ✗ | ✗ |
Network-level dashboards — status across all sites in one view | ✓ | ✓ | ~ | ✗ | ✗ |
One platform serving sponsor/CRO and site/network perspectives | ✓ | ~ | ~ | ✗ | ✗ |
Designed for NHS research networks (hub-and-spoke model) | ✓ | ✗ | ✗ | ✗ | ✗ |
INTEROPERABILITY & INTEGRATION | |||||
Single sign-on (SSO) across all modules | ~ — on AQ 2.0 roadmap | ✓ | ✓ | ✓ | ✗ |
Open API for integration with EDC, CTMS, and institutional systems | ~ — on AQ 2.0 roadmap | ✓ | ~ | ~ | ✗ |
EDC / REDCap integration | ~ — on AQ 2.0 roadmap | ✓ | ~ | ✗ | ✗ |
PRICING AND DEPLOYMENT | |||||
Mid-market pricing — no enterprise contract required | ✓ | ✗ — enterprise pricing model | ✓ | ✓ | — no software cost |
Modular pricing — pay for what you use | ✓ | ✗ — platform pricing | ~ | ✓ | — N/A |
ePSF, CAPA, and QMS included in platform pricing | ✓ | ✗ | ✗ | ✗ | ✗ |
Rapid deployment without lengthy implementation | ✓ | ✗ — implementation programme | ✓ | ✓ | — no implementation, but ongoing drag |
AQ ePSF — Electronic Pharmacy Site File
How AQ ePSF compares against the four categories of competitor commonly found in clinical research, based on investigational product control, pharmacy oversight, study integration, and inspection readiness. AQ is unique in the mid-market in offering a native pharmacy site file connected to the study record.
Capability | AQ Trials | Legacy enterprise | Mid-market modular | Point eRegulatory | Paper & spreadsheets |
PHARMACY DOCUMENTATION CORE | |||||
Dedicated pharmacy site file module | ✓ | ✗ | ✗ | ✗ | ✗ |
IP receipt logging with batch and shipment tracking | ✓ | ✗ | ✗ | ✗ | ~ |
Storage condition and temperature monitoring records | ✓ | ✗ | ✗ | ✗ | ✗ |
Dispensing records linked to participant, visit, and study | ✓ | ✗ | ✗ | ✗ | ~ |
Inventory tracking with reconciliation workflows | ✓ | ✗ | ✗ | ✗ | ~ |
Return and destruction records with audit linkage | ✓ | ✗ | ✗ | ✗ | ✗ |
IP accountability log auto-generated for monitoring | ✓ | ✗ | ✗ | ✗ | ~ |
REGULATORY COMPLIANCE | |||||
21 CFR Part 11 and ICH-GCP compliance | ✓ | ✓ | ✓ | ✓ | ✗ |
EU Annex 11 compliance | ✓ | ✓ | ✓ | ✓ | ✗ |
UK GDPR-aligned data handling and PHI separation | ✓ | ~ | ~ | ~ | ✗ |
Role-based access for pharmacy staff | ✓ | ✗ | ✗ | ✗ | ~ |
Immutable audit trail across pharmacy actions | ✓ | ✗ | ✗ | ✗ | ✗ |
WORM storage enforcement for pharmacy records | ✓ | ✗ | ✗ | ✗ | ✗ |
STUDY INTEGRATION | |||||
ePSF within the same study record as eISF and eTMF | ✓ | ✗ | ✗ | ✗ | ✗ |
Pharmacy records linked to delegation log (DOA) | ✓ | ✗ | ✗ | ✗ | ✗ |
Pharmacy records linked to participant and visit records | ✓ | ✗ | ✗ | ✗ | ~ |
Pharmacy SOPs linked to QMS controlled documents | ✓ | ✗ | ✗ | ✗ | ✗ |
Pharmacy deviations linked to CAPA | ✓ | ✗ | ✗ | ✗ | ✗ |
Single login across all study modules | ✓ | ✓ | ✓ | ✓ | ✗ |
OVERSIGHT AND MONITORING | |||||
Remote monitor access to pharmacy records | ✓ | ✗ | ✗ | ✗ | ✗ |
Sponsor visibility without manual transfer | ✓ | ✗ | ✗ | ✗ | ~ |
Cross-site IP accountability dashboards | ✓ | ✗ | ✗ | ✗ | ~ |
Inspection-ready pharmacy export | ✓ | ✗ | ✗ | ✗ | ✗ |
ANALYTICS AND REPORTING | |||||
IP accountability completeness tracking | ✓ | ✗ | ✗ | ✗ | ~ |
Dispensing pattern reporting per site | ✓ | ✗ | ✗ | ✗ | ~ |
Temperature excursion event reporting | ✓ | ✗ | ✗ | ✗ | ✗ |
AI-assisted gap detection across pharmacy records | ✓ | ✗ | ✗ | ✗ | ✗ |
Custom report builder | ✓ | ✓ | ✓ | ✓ | ✗ |
WORKFLOW AND AUTOMATION | |||||
Automated alerts for expiring stock | ✓ | ✗ | ✗ | ✗ | ~ |
Approval workflows for IP destruction | ✓ | ✗ | ✗ | ✗ | ✗ |
Automated reconciliation reports | ✓ | ✗ | ✗ | ✗ | ~ |
Pharmacy training records linked to staff and SOPs | ✓ | ✗ | ✗ | ✗ | ✗ |
ARCHIVE AND RETENTION | |||||
Legal hold on pharmacy records | ✓ | ✗ | ✗ | ✗ | ✗ |
Retention policy aligned to GCP requirements | ✓ | ✗ | ✗ | ✗ | ✗ |
Inspection-ready archive export | ✓ | ✗ | ✗ | ✗ | ✗ |
25-year retention with tiered storage | ✓ | ✗ | ✗ | ✗ | ✗ |
UK / NHS DEPLOYMENT & ASSURANCE | |||||
UK / EU data residency — data hosted and held in the UK/EU | ✓ | ~ | ~ | ~ | ~ |
UK-based implementation and support team | ✓ | ~ | ~ | ~ | ✗ |
ICH E6(R3) aligned — current Good Clinical Practice revision | ✓ | ✓ | ✓ | ~ | ✗ |
Built for NHS and UK research governance (HRA / MHRA-aligned) | ✓ | ✗ | ✗ | ✗ | ~ |
NHS Data Security & Protection Toolkit (DSPT) | ✓ | ~ | ~ | ✗ | ✗ |
NHS DTAC — Digital Technology Assessment Criteria | ~ — in progress | ~ | ~ | ✗ | ✗ |
ISO 27001 certified | ~ — in progress | ✓ | ✓ | ~ | ✗ |
Cyber Essentials | ✓ | ~ | ~ | ✗ | ✗ |
RESEARCH NETWORK & MULTI-SITE OVERSIGHT | |||||
Hub-and-spoke / coordinating-centre oversight across multiple sites | ✓ | ✓ | ~ | ✗ | ✗ |
Network-level dashboards — status across all sites in one view | ✓ | ✓ | ~ | ✗ | ✗ |
One platform serving sponsor/CRO and site/network perspectives | ✓ | ~ | ~ | ✗ | ✗ |
Designed for NHS research networks (hub-and-spoke model) | ✓ | ✗ | ✗ | ✗ | ✗ |
INTEROPERABILITY & INTEGRATION | |||||
Single sign-on (SSO) across all modules | ~ — on AQ 2.0 roadmap | ✓ | ✓ | ✓ | ✗ |
Open API for integration with EDC, CTMS, and institutional systems | ~ — on AQ 2.0 roadmap | ✓ | ~ | ~ | ✗ |
EDC / REDCap integration | ~ — on AQ 2.0 roadmap | ✓ | ~ | ✗ | ✗ |
PRICING AND DEPLOYMENT | |||||
Mid-market pricing — no enterprise contract required | ✓ | ✗ — enterprise pricing | ✓ | ✓ | — no software cost |
Included in connected platform pricing | ✓ | ✗ — not offered | ✗ — not offered | ✗ — not offered | — N/A |
Rapid deployment without lengthy implementation | ✓ | ✗ — implementation programme | ✓ | ✓ | — no implementation, but ongoing drag |
AQ QMS — Quality Management System
How AQ QMS compares against the four categories of competitor commonly found in clinical research and life sciences quality, based on controlled document management, training, deviation control, change control, and the capabilities that matter to research governance teams.
Capability | AQ Trials | Legacy enterprise | Mid-market modular | Point eRegulatory | Paper & spreadsheets |
CONTROLLED DOCUMENT CORE | |||||
SOP, work instruction, form, and policy lifecycle | ✓ | ✓ | ✓ | ✗ | ~ |
Version control with immutable document history | ✓ | ✓ | ✓ | ✗ | ✗ |
Document template library | ✓ | ✓ | ✓ | ✗ | ~ |
Periodic review scheduling and alerts | ✓ | ✓ | ✓ | ✗ | ✗ |
Document expiry tracking | ✓ | ✓ | ✓ | ✗ | ✗ |
Side-by-side version comparison | ~ | ✓ | ✓ | ✗ | ✗ |
Effective date management | ✓ | ✓ | ✓ | ✗ | ✗ |
REGULATORY COMPLIANCE | |||||
21 CFR Part 11 e-signatures | ✓ | ✓ | ✓ | ✗ | ✗ |
EU Annex 11 compliance | ✓ | ✓ | ✓ | ✗ | ✗ |
ICH Q10 alignment | ✓ | ✓ | ✓ | ✗ | ✗ |
UK GDPR-aligned data handling | ✓ | ~ | ~ | ✗ | ✗ |
Role-based access control | ✓ | ✓ | ✓ | ✗ | ~ |
Immutable audit trail across all actions | ✓ | ✓ | ✓ | ✗ | ✗ |
Third-party Part 11 validation pack | ✓ | ✓ | ✓ | ✗ | ✗ |
TRAINING AND ACKNOWLEDGEMENT | |||||
Read-and-understand acknowledgement tracking | ✓ | ✓ | ✓ | ✗ | ✗ |
Training records linked to SOPs and role assignments | ✓ | ✓ | ✓ | ✗ | ✗ |
Training records linked to delegation log (DOA) | ✓ | ✗ | ✗ | ✗ | ✗ |
Re-training triggered on SOP revision | ✓ | ✓ | ✓ | ✗ | ✗ |
Competency tracking per role | ✓ | ✓ | ~ | ✗ | ✗ |
STUDY INTEGRATION | |||||
QMS within the same study record as eISF, eTMF, ePSF | ✓ | ✗ | ✗ | ✗ | ✗ |
Study-specific SOPs linked to study record | ✓ | ✗ | ✗ | ✗ | ✗ |
Pharmacy SOPs linked to ePSF | ✓ | ✗ | ✗ | ✗ | ✗ |
Deviation linkage to CAPA inside the study record | ✓ | ✓ | ✓ | ✗ | ✗ |
Single login across all study modules | ✓ | ✓ | ✓ | ✗ | ✗ |
QUALITY EVENTS AND CHANGE CONTROL | |||||
Deviation logging with classification | ✓ | ✓ | ✓ | ✗ | ~ |
Root cause analysis workflow | ✓ | ✓ | ✓ | ✗ | ✗ |
Change control workflow with impact assessment | ✓ | ✓ | ✓ | ✗ | ✗ |
Approval routing for change control | ✓ | ✓ | ✓ | ✗ | ✗ |
Quality event audit trail | ✓ | ✓ | ✓ | ✗ | ✗ |
Risk register and risk-based quality management (ICH E6(R3)) | ✓ | ✓ | ~ | ✗ | ✗ |
Internal audit scheduling and management | ✓ | ✓ | ✓ | ✗ | ~ |
ANALYTICS AND REPORTING | |||||
Document compliance dashboards | ✓ | ✓ | ✓ | ✗ | ✗ |
Training compliance dashboards | ✓ | ✓ | ✓ | ✗ | ✗ |
AI-assisted gap detection across SOPs and training | ✓ | ~ | ~ — emerging across category | ✗ | ✗ |
Custom report builder | ✓ | ✓ | ✓ | ✗ | ✗ |
Inspection readiness scoring | ✓ | ✓ | ✓ | ✗ | ✗ |
WORKFLOW AND AUTOMATION | |||||
Multi-step approval workflows | ✓ | ✓ | ✓ | ✗ | ✗ |
Automated distribution of new and revised documents | ✓ | ✓ | ✓ | ✗ | ✗ |
Reason-for-change capture on every revision | ✓ | ✓ | ✓ | ✗ | ✗ |
Configurable workflows without vendor services | ✓ | ~ | ✓ | ✗ | ✗ |
UK / NHS DEPLOYMENT & ASSURANCE | |||||
UK / EU data residency — data hosted and held in the UK/EU | ✓ | ~ | ~ | ~ | ~ |
UK-based implementation and support team | ✓ | ~ | ~ | ~ | ✗ |
ICH E6(R3) aligned — current Good Clinical Practice revision | ✓ | ✓ | ✓ | ~ | ✗ |
Built for NHS and UK research governance (HRA / MHRA-aligned) | ✓ | ✗ | ✗ | ✗ | ~ |
NHS Data Security & Protection Toolkit (DSPT) | ~ — in progress | ~ | ~ | ✗ | ✗ |
NHS DTAC — Digital Technology Assessment Criteria | ~ — in progress | ~ | ~ | ✗ | ✗ |
ISO 27001 certified | ~ — in progress | ✓ | ✓ | ~ | ✗ |
Cyber Essentials Plus | ~ — in progress | ~ | ~ | ✗ | ✗ |
RESEARCH NETWORK & MULTI-SITE OVERSIGHT | |||||
Hub-and-spoke / coordinating-centre oversight across multiple sites | ✓ | ✓ | ~ | ✗ | ✗ |
Network-level dashboards — status across all sites in one view | ✓ | ✓ | ~ | ✗ | ✗ |
One platform serving sponsor/CRO and site/network perspectives | ✓ | ~ | ~ | ✗ | ✗ |
Designed for NHS research networks (hub-and-spoke model) | ✓ | ✗ | ✗ | ✗ | ✗ |
INTEROPERABILITY & INTEGRATION | |||||
Single sign-on (SSO) across all modules | ~ — on AQ 2.0 roadmap | ✓ | ✓ | ✓ | ✗ |
Open API for integration with EDC, CTMS, and institutional systems | ~ — on AQ 2.0 roadmap | ✓ | ~ | ~ | ✗ |
EDC / REDCap integration | ~ — on AQ 2.0 roadmap | ✓ | ~ | ✗ | ✗ |
PRICING AND DEPLOYMENT | |||||
Mid-market pricing — no enterprise contract required | ✓ | ✗ — enterprise pricing model | ✓ | ✗ | — no software cost |
Modular pricing — pay for what you use | ✓ | ✗ — platform pricing | ✓ | ✗ | — N/A |
eISF, eTMF, ePSF, CAPA, DOA included in platform pricing | ~ | ✗ | ✗ | ✗ | ✗ |
Rapid deployment without lengthy implementation | ✓ | ✗ — implementation programme | ✓ | ✗ | — no implementation, but ongoing drag |
AQ CAPA — Corrective & Preventive Action
How AQ CAPA compares against the four categories of competitor commonly found in clinical research and life sciences quality, based on issue capture, root cause analysis, action tracking, closure verification, and the capabilities that matter to quality and governance teams.
Capability | AQ Trials | Legacy enterprise | Mid-market modular | Point eRegulatory | Paper & spreadsheets |
CAPA CORE WORKFLOW | |||||
Issue and deviation capture | ✓ | ✓ | ✓ | ✗ | ~ |
Multiple intake points (audit, monitoring, complaint, self-report) | ✓ | ✓ | ✓ | ✗ | ✗ |
Root cause analysis framework | ✓ | ✓ | ✓ | ✗ | ✗ |
Action assignment with owner and due date | ✓ | ✓ | ✓ | ✗ | ~ |
Recurring and repeat issue detection | ✓ | ✓ | ✓ | ✗ | ✗ |
Effectiveness check workflow | ✓ | ✓ | ✓ | ✗ | ✗ |
Cross-study CAPA register | ✓ | ✓ | ✓ | ✗ | ✗ |
REGULATORY COMPLIANCE | |||||
21 CFR Part 11 e-signatures | ✓ | ✓ | ✓ | ✗ | ✗ |
EU Annex 11 compliance | ✓ | ✓ | ✓ | ✗ | ✗ |
ICH Q9 and Q10 alignment | ✓ | ✓ | ✓ | ✗ | ✗ |
UK GDPR-aligned data handling | ✓ | ~ | ~ | ✗ | ✗ |
Role-based access control | ✓ | ✓ | ✓ | ✗ | ~ |
Immutable audit trail across all actions | ✓ | ✓ | ✓ | ✗ | ✗ |
Third-party Part 11 validation pack | ✓ | ✓ | ✓ | ✗ | ✗ |
QUALITY EVENT LINKAGE | |||||
CAPA linked to controlled documents (SOPs) | ✓ | ✓ | ✓ | ✗ | ✗ |
CAPA linked to training and delegation gaps | ✓ | ✗ | ✗ | ✗ | ✗ |
CAPA linked to study deviations and findings | ✓ | ~ | ~ | ✗ | ✗ |
CAPA linked to pharmacy records (IP issues) | ✓ | ✗ | ✗ | ✗ | ✗ |
CAPA linked to eISF and eTMF documents | ✓ | ✗ | ✗ | ✗ | ✗ |
CAPA linked to CTMS | ✓ | ✗ | ✗ | ✗ | ✗ |
STUDY INTEGRATION | |||||
CAPA within the same study record as eISF, eTMF, ePSF | ✓ | ✗ | ✗ | ✗ | ✗ |
Quality events traceable to study, site, and participant | ✓ | ~ | ~ | ✗ | ✗ |
Single login across all study modules | ✓ | ✓ | ✓ | ✗ | ✗ |
ANALYTICS AND REPORTING | |||||
Open action dashboards per team, study, and site | ✓ | ✓ | ✓ | ✗ | ✗ |
Overdue action tracking and escalation | ✓ | ✓ | ✓ | ✗ | ✗ |
Recurring issue and trend analysis | ✓ | ✓ | ✓ | ✗ | ✗ |
AI-assisted gap and anomaly detection | ✓ | ~ | ~ — emerging across category | ✗ | ✗ |
Custom report builder | ✓ | ✓ | ✓ | ✗ | ✗ |
Inspection-ready CAPA register export | ✓ | ✓ | ✓ | ✗ | ✗ |
WORKFLOW AND AUTOMATION | |||||
Multi-step approval workflows | ✓ | ✓ | ✓ | ✗ | ✗ |
Owner notifications and reminders | ✓ | ✓ | ✓ | ✗ | ✗ |
Overdue escalation rules | ✓ | ✓ | ✓ | ✗ | ✗ |
Reason-for-change capture | ✓ | ✓ | ✓ | ✗ | ✗ |
Closure verification with evidence | ✓ | ✓ | ✓ | ✗ | ✗ |
ARCHIVE AND RETENTION | |||||
Legal hold on closed CAPAs | ✓ | ✓ | ~ | ✗ | ✗ |
Retention policy with configurable periods | ✓ | ✓ | ✓ | ✗ | ✗ |
Inspection-ready archive export | ✓ | ✓ | ✓ | ✗ | ✗ |
Full audit lineage preserved on archive | ✓ | ✓ | ✓ | ✗ | ✗ |
UK / NHS DEPLOYMENT & ASSURANCE | |||||
UK / EU data residency — data hosted and held in the UK/EU | ✓ | ~ | ~ | ~ | ~ |
UK-based implementation and support team | ✓ | ~ | ~ | ~ | ✗ |
ICH E6(R3) aligned — current Good Clinical Practice revision | ✓ | ✓ | ✓ | ~ | ✗ |
Built for NHS and UK research governance (HRA / MHRA-aligned) | ✓ | ✗ | ✗ | ✗ | ~ |
NHS Data Security & Protection Toolkit (DSPT) | ~ — in progress | ~ | ~ | ✗ | ✗ |
NHS DTAC — Digital Technology Assessment Criteria | ~ — in progress | ~ | ~ | ✗ | ✗ |
ISO 27001 certified | ~ — in progress | ✓ | ✓ | ~ | ✗ |
Cyber Essentials Plus | ~ — in progress | ~ | ~ | ✗ | ✗ |
RESEARCH NETWORK & MULTI-SITE OVERSIGHT | |||||
Hub-and-spoke / coordinating-centre oversight across multiple sites | ✓ | ✓ | ~ | ✗ | ✗ |
Network-level dashboards — status across all sites in one view | ✓ | ✓ | ~ | ✗ | ✗ |
One platform serving sponsor/CRO and site/network perspectives | ✓ | ~ | ~ | ✗ | ✗ |
Designed for NHS research networks (hub-and-spoke model) | ✓ | ✗ | ✗ | ✗ | ✗ |
INTEROPERABILITY & INTEGRATION | |||||
Single sign-on (SSO) across all modules | ~ — on AQ 2.0 roadmap | ✓ | ✓ | ✓ | ✗ |
Open API for integration with EDC, CTMS, and institutional systems | ~ — on AQ 2.0 roadmap | ✓ | ~ | ~ | ✗ |
EDC / REDCap integration | ~ — on AQ 2.0 roadmap | ✓ | ~ | ✗ | ✗ |
PRICING AND DEPLOYMENT | |||||
Mid-market pricing — no enterprise contract required | ✓ | ✗ — enterprise pricing model | ✓ | ✗ | — no software cost |
Modular pricing — pay for what you use | ✓ | ✗ — platform pricing | ✓ | ✗ | — N/A |
eISF, eTMF, ePSF, QMS, DOA included in platform pricing | ✓ | ✗ | ✗ | ✗ | ✗ |
Rapid deployment without lengthy implementation | ✓ | ✗ — implementation programme | ✓ | ✗ | — no implementation, but ongoing drag |
AQ DOA — Digital Delegation of Authority
How AQ DOA compares against the four categories of competitor commonly found in clinical research, based on delegation logging, study connection, training linkage, inspection readiness, and the capabilities that matter to PIs, coordinators, and monitors.
Capability | AQ Trials | Legacy enterprise | Mid-market modular | Point eRegulatory | Paper & spreadsheets |
DELEGATION CORE | |||||
Per-study delegation log | ✓ | ✓ | ~ | ✓ | ~ |
Role-based delegation | ✓ | ✓ | ~ | ✓ | ✗ |
Start and end date with auto-expiry | ✓ | ✓ | ~ | ✓ | ✗ |
PI signature workflow | ✓ | ✓ | ~ | ✓ | ~ |
Bulk delegation across roles | ✓ | ✓ | ~ | ~ | ✗ |
Cross-study delegation views | ✓ | ✓ | ~ | ~ | ✗ |
Re-delegation on role or staff change | ✓ | ✓ | ~ | ✓ | ✗ |
REGULATORY COMPLIANCE | |||||
21 CFR Part 11 e-signatures | ✓ | ✓ | ✓ | ✓ | ✗ |
EU Annex 11 compliance | ✓ | ✓ | ✓ | ✓ | ✗ |
ICH-GCP alignment | ✓ | ✓ | ✓ | ✓ | ✗ |
UK GDPR-aligned data handling | ✓ | ~ | ~ | ~ | ✗ |
Role-based access control | ✓ | ✓ | ✓ | ✓ | ~ |
Immutable audit trail across delegation actions | ✓ | ✓ | ✓ | ✓ | ✗ |
Third-party Part 11 validation pack | ✓ | ✓ | ✓ | ✓ | ✗ |
STUDY INTEGRATION | |||||
DOA within the same study record as eISF, eTMF, ePSF | ✓ | ✗ | ✗ | ~ | ✗ |
Delegation linked to training records | ✓ | ~ | ~ | ~ | ✗ |
Delegation linked to controlled SOPs (QMS) | ✓ | ~ | ✗ | ✗ | ✗ |
Delegation linked to pharmacy records (ePSF) | ✓ | ✗ | ✗ | ✗ | ✗ |
Delegation linked to CAPA on training or competency gaps | ✓ | ✗ | ✗ | ✗ | ✗ |
Single login across all study modules | ✓ | ✓ | ✓ | ✓ | ✗ |
VISIBILITY AND OVERSIGHT | |||||
Remote monitor access to delegation log | ✓ | ✓ | ✓ | ✓ | ✗ |
Sponsor visibility without manual transfer | ✓ | ✓ | ~ | ~ | ✗ |
Multi-site delegation oversight | ✓ | ✓ | ~ | ✓ | ✗ |
Active vs historical delegation views | ✓ | ✓ | ✓ | ✓ | ✗ |
Inspection-ready DOA log export | ✓ | ✓ | ✓ | ✓ | ~ |
ANALYTICS AND REPORTING | |||||
Delegation status dashboards per study and site | ✓ | ✓ | ✓ | ✓ | ✗ |
Expiring and expired delegation alerts | ✓ | ✓ | ✓ | ✓ | ✗ |
Training and competency gap reporting | ✓ | ~ | ~ | ~ | ✗ |
AI-assisted anomaly detection on delegation patterns | ✓ | ~ | ✗ | ✗ | ✗ |
Custom report builder | ✓ | ✓ | ✓ | ✓ | ✗ |
WORKFLOW AND AUTOMATION | |||||
Automated workflows for delegation approval | ✓ | ✓ | ✓ | ✓ | ✗ |
Reason-for-change capture on every delegation action | ✓ | ✓ | ✓ | ✓ | ✗ |
Reminders and escalations for pending PI approval | ✓ | ✓ | ✓ | ✓ | ✗ |
Automated re-delegation triggers on role change | ✓ | ~ | ~ | ~ | ✗ |
Automatic suspension of SOP and pharmacy access on delegation expiry | ✓ | ✗ | ✗ | ~ | ✗ |
ARCHIVE AND RETENTION | |||||
Legal hold on delegation records | ✓ | ✓ | ✗ | ✗ | ✗ |
Retention policy with configurable periods | ✓ | ✓ | ~ | ~ | ✗ |
Inspection-ready archive export with integrity manifest | ✓ | ✓ | ~ | ~ | ✗ |
25-year retention with tiered storage | ✓ | ✓ | ~ | ~ | ✗ |
UK / NHS DEPLOYMENT & ASSURANCE | |||||
UK / EU data residency — data hosted and held in the UK/EU | ✓ | ~ | ~ | ~ | ~ |
UK-based implementation and support team | ✓ | ~ | ~ | ~ | ✗ |
ICH E6(R3) aligned — current Good Clinical Practice revision | ✓ | ✓ | ✓ | ~ | ✗ |
Built for NHS and UK research governance (HRA / MHRA-aligned) | ✓ | ✗ | ✗ | ✗ | ~ |
NHS Data Security & Protection Toolkit (DSPT) | ~ — in progress | ~ | ~ | ✗ | ✗ |
NHS DTAC — Digital Technology Assessment Criteria | ~ — in progress | ~ | ~ | ✗ | ✗ |
ISO 27001 certified | ~ — in progress | ✓ | ✓ | ~ | ✗ |
Cyber Essentials Plus | ~ — in progress | ~ | ~ | ✗ | ✗ |
RESEARCH NETWORK & MULTI-SITE OVERSIGHT | |||||
Hub-and-spoke / coordinating-centre oversight across multiple sites | ✓ | ✓ | ~ | ✗ | ✗ |
Network-level dashboards — status across all sites in one view | ✓ | ✓ | ~ | ✗ | ✗ |
One platform serving sponsor/CRO and site/network perspectives | ✓ | ~ | ~ | ✗ | ✗ |
Designed for NHS research networks (hub-and-spoke model) | ✓ | ✗ | ✗ | ✗ | ✗ |
INTEROPERABILITY & INTEGRATION | |||||
Single sign-on (SSO) across all modules | ~ — on AQ 2.0 roadmap | ✓ | ✓ | ✓ | ✗ |
Open API for integration with EDC, CTMS, and institutional systems | ~ — on AQ 2.0 roadmap | ✓ | ~ | ~ | ✗ |
EDC / REDCap integration | ~ — on AQ 2.0 roadmap | ✓ | ~ | ✗ | ✗ |
PRICING AND DEPLOYMENT | |||||
Mid-market pricing — no enterprise contract required | ✓ | ✗ — enterprise pricing model | ✓ | ✓ | — no software cost |
Modular pricing — pay for what you use | ✓ | ✗ — platform pricing | ✓ | ✓ | — N/A |
eISF, eTMF, ePSF, QMS, CAPA included in platform pricing | ✓ | ✗ | ✗ | ✗ | ✗ |
Rapid deployment without lengthy implementation | ✓ | ✗ — implementation programme | ✓ | ✓ | — no implementation, but ongoing drag |
The operational outcomes only a connected platform can deliver.
Less time coordinating, more time researching.
Documentation, operations, quality, and pharmacy run on the same study record, removing the need to chase status, reconcile records, or cross- check between systems.
Quality issues resolve faster.
Deviations and CAPAs connect to documents, study activity, and delegation, allowing teams to act without assembling information from separate systems.
Real-time visibility without requesting it.
Role-based access provides direct oversight within the study environment, without document preparation or transfer for Sponsors and CROs.
Studies close out smoothly.
Documents, quality events, pharmacy records, and delegation logs exist within one environment, allowing close-out to follow a governed transition.
See how AQ fits your research programme.
Request a live demonstration to walk through how AQ connects documentation, study operations, pharmacy governance, quality management, and delegation across your active studies. See each module in the context of your workflows and understand how AQ can be deployed without an enterprise implementation programme.
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Here is what our Clients are saying About us
It was a very good experience
This has revolutionised the way we work and improved efficiencies and study compliance reducing admin time spent sending reminders.
– Angie H.
Research Nurse
Both the AQ product and the team were flexible in their approach, they listened to our challenges and were able to embed the AQ platform with ease. The team was trained quickly and we were up and running in no time. The system has enabled us to manage more studies and transformed the way we work.
It was a very good experience
– Fran Westwell
Lead / Senior Research Nurse
It was a very good experience
The AscensionQ platform has helped my research staff set-up multiple studies faster and manage participant appointments more effectively. The software is easy to use and the team is always there to help us.
