Getting Started
What is AQ?
AQ is a clinical research management platform that connects CTMS, eTMF, eISF, ePSF, QMS, CAPA and Digital DoA in one controlled environment. The modules share a single study record, so study execution, documentation, pharmacy accountability, delegation, quality and corrective actions stay connected — and the record stays inspection-ready every day, not only before a monitoring visit or inspection.
Who is AQ designed for?
AQ supports regulated research and quality teams that manage multiple studies, sites and regulatory requirements:
- NHS and hospital research units
- academic research institutions and clinical trials units
- sponsors and sponsor oversight teams
- contract research organisations (CROs)
- biotech and medtech teams approaching IND, CTA or ISO 13485 — before there is a dedicated quality department
- multi-site research networks
Is AQ suitable for medtech and device companies?
Yes. Alongside clinical research, AQ’s QMS and CAPA support medtech and biotech quality programmes built to ISO 13485, the FDA QMSR (21 CFR Part 820) and ICH Q10 — useful for teams approaching IND, CTA, ISO 13485 certification or a first vendor-qualification audit.
Is AQ worth setting up before we have a quality team?
Yes — this is the most common starting point. Teams typically begin with QMS, CAPA, eISF and ePSF, because a quality system improvised at five people becomes a remediation project at fifty. AQ is audit-ready by default rather than assembled before a visit, and needs no extra hires to keep current as you scale.
What modules does AQ include?
AQ is modular. Seven connected modules share one study record:
- CTMS — clinical trial management: study and site set-up, recruitment and enrolment, visit and milestone scheduling, monitoring and operational reporting
- eTMF — the sponsor’s trial master file: the complete set of essential documents for the whole trial, organised to the TMF Reference Model across trial, country and site levels
- eISF — the investigator site file: the site’s own essential-document file (the site-held counterpart of the TMF) — structured folders, signatures, versions and monitor access
- ePSF — the pharmacy site file: the pharmacy’s essential records for the investigational product — accountability, dispensing, storage and temperature logs
- QMS — quality governance: controlled SOPs, training, acknowledgements and deviation management
- CAPA — corrective and preventive actions, linked to the record that raised them, through to verified closure
- Digital DoA — the delegation-of-authority log: which trial tasks the PI has delegated to which trained, qualified staff, tied to signatures, dates and role history
Can I use AQ for a single module only?
Yes. AQ is modular. You can deploy CTMS, eTMF, eISF, ePSF, QMS, CAPA or Digital DoA independently and add modules as your research operations grow. Because the modules share one record, each addition builds on what is already there, with no separate onboarding each time.
What is the difference between eISF and eTMF?
The eTMF (Trial Master File) is the sponsor’s master file for the entire trial — the full set of essential documents, across every site and country, that lets the conduct of the trial be reconstructed and inspected, organised to the TMF Reference Model. The eISF (Investigator Site File) is the site’s own file — the site-level essential documents held by the investigator. They mirror each other: the ISF is effectively the site-held counterpart of the sponsor’s TMF, and the two should always reconcile. AQ manages both, so the same document at site and sponsor level stays in step within one study record.
What is the difference between eISF and ePSF?
The eISF (Investigator Site File) is the site’s complete collection of essential trial documents — CVs, GCP training, ethics and regulatory approvals, signed consent versions, the delegation log and monitoring records. The ePSF (Pharmacy Site File) is the pharmacy’s equivalent for the investigational product — drug receipt and accountability, dispensing, storage and temperature records. The ePSF covers the pharmacy domain a general site file doesn’t reach. Both sit under the same controls — structured folders, role-based access, version control and audit trail — and stay connected within the study record.
How is AQ different from a CTMS, a shared drive or a sponsor portal?
- A CTMS (Clinical Trial Management System) manages the operational side of running a study — site set-up and activation, recruitment and enrolment, visit and milestone scheduling, monitoring and operational reporting. It tracks how the study is run, not the controlled documents and evidence behind it. AQ includes CTMS capability and connects it to the document, pharmacy, quality and delegation record, so operations and evidence sit in one place.
- A shared drive stores files. AQ controls them — versioned, permissioned, signed and fully audit-trailed.
- A sponsor portal belongs to one sponsor. AQ is your organisation’s own controlled environment, used across every sponsor and study.
How quickly can AQ be implemented?
AQ can be configured within one day. Full onboarding, including setup and training, typically completes within two to three days depending on team availability.
Platform & Features
What does AQ replace in my current workflow?
AQ brings disconnected tools into one structured system, replacing:
• spreadsheets used for tracking
• shared drives used for document storage
• separate tools for training, compliance and CAPA
• paper delegation logs and paper pharmacy logs
How does AQ manage document control?
AQ uses template-driven structures with:
• a predefined folder hierarchy applied at study creation
• version control with controlled supersession and automatic archiving of superseded versions
• role-based access
• full document traceability and audit history
How are user roles and permissions handled?
AQ uses policy-driven, role-based access control. Permissions are granular and assigned per action — view, upload, edit, move, sign, restrict — at study and document level, with every action attributed to a user. Access follows least-privilege principles, supports SSO, and a System Administrator manages roles centrally.
What is eISF in AQ?
AQ eISF is a study-scoped, template-driven investigator site file — the site’s own collection of essential trial documents. Folder structure and milestone-driven document requirements are applied automatically, due dates are calculated, and signatures lock documents once complete. It keeps site documents organised, version-controlled, reviewed, signed and continuously inspection-ready, with role-based access and a complete audit trail. Monitors and sponsors get secure, controlled remote access without a separate login for every site.
What is ePSF in AQ?
AQ ePSF brings pharmacy documentation and investigational product accountability into the same controlled environment as the rest of the study. It manages drug receipt, dispensing, returns and reconciliation, storage and temperature records, and pharmacy authorisations — with the same audit trail, signatures and inspection readiness as eISF. Few platforms manage the pharmacy site file natively; AQ does.
What is Digital DoA?
AQ Digital DoA replaces the paper delegation-of-authority log. It records which trial tasks the Principal Investigator has delegated to which trained, qualified team members — every delegated responsibility tied to a signature, a date and a role history, and mapped to the tasks the person is authorised to perform. When a role changes, the record changes with it — and a question about who was authorised, and when, is answered in minutes rather than an afternoon.
Does AQ use AI — and is it safe for regulated use?
Yes. AQ uses AI to assist with document checks and completeness — for example, surfacing missing, misfiled or at-risk items. Every AI check is human-in-the-loop and audit-trailed: AI proposes, a person confirms, and the action is recorded like any other. AI never closes a record or signs on a user’s behalf.
Can AQ raise a CAPA automatically from another module?
Yes. A finding anywhere in the platform can raise a CAPA at the point of discovery — a temperature excursion in ePSF, a missing document in eISF, a training gap in QMS — each entering the same CAPA lifecycle, with the same verification requirement and audit trail. The issue and its resolution stay connected to the record that revealed it.
How does AQ support inspection readiness?
- AQ keeps the record continuously defensible rather than reconstructed before a visit. Readiness is scored in real time per site and study, with missing, overdue and at-risk items surfaced as they arise. Documentation, pharmacy accountability and quality actions can be evidenced from one connected record, with a single audit trail and export.
Does AQ support electronic signatures?
Yes. AQ provides electronic signatures built to support 21 CFR Part 11, with re-authentication at the point of signing using position-based two-factor verification (a password plus randomly selected digits from a personal access code), mandatory-signer enforcement, and tamper-evident document integrity. For documents brought in from outside the platform, a Certification of True Copy wizard generates a SHA-256 hash at certification, so any later change is detectable. A full signature audit trail — who signed, when, which version and from where — is captured automatically.
What ingest and integration points does AQ support?
AQ connects its own modules through a shared study record, so they never need integrating with each other. For external data, AQ supports structured ingest including document upload, email-in, eConsent, IRT/RTSM, EDC/eCRF and temperature loggers, and can push to a sponsor’s eTMF. Speak to the AQ team about which connections are available for your setup.
Compliance & Security
Which regulatory standards does AQ align with?
AQ is built to support the standards regulated UK and international research operates under:
• ICH-GCP E6(R3)
• UK Clinical Trials Regulations and MHRA inspection expectations
• ALCOA+ data-integrity principles
• 21 CFR Part 11 and EU Annex 11 (electronic records and signatures)
• UK GDPR and the Data Protection Act 2018
For medtech and device quality programmes, AQ also supports ISO 13485, the FDA QMSR (21 CFR Part 820) and ICH Q10.
AQ supports alignment with these standards through system controls; it does not claim certification on a customer’s behalf.
How does AQ maintain data integrity?
AQ enforces integrity through system controls rather than manual effort:
• an immutable, time-stamped audit trail on every action
• version-controlled documents with no permanent deletion
• role-based, least-privilege access
• tamper-evident document integrity (SHA-256 hash) on certified records
Where is data stored?
AQ operates in a secure, UK-hosted cloud environment built for regulated clinical research, with encryption in transit and at rest, role-based access, continuous activity monitoring, and backup and disaster-recovery controls.
How long is data retained and archived?
AQ retains records under long-term archive controls aligned to MHRA expectations and EU CTR (536/2014, Art. 58) — up to 25 years following study completion. Nothing is permanently deleted; removed items are archived with full history and remain restorable, and each restoration is logged.
Who owns the data in AQ?
Your organisation owns and controls its own data, including documents and records, and decides what is shared and with whom — for example, monitor or auditor access.
How does AQ control access to data?
Access is role-based and least-privilege, scoped at study and document level, and supports SSO. Monitors, auditors and inspectors receive controlled, time-bound external access to only what they need, and every action is attributed and recorded in the audit trail.
Is validation (IQ/OQ/PQ) documentation available?
AQ is developed under GxP / GAMP 5 computerised-system validation practices. Validation documentation (IQ/OQ/PQ) and a validation summary are available to sponsors and QA teams on request, typically under NDA.
What security assurances does AQ provide?
AQ’s security controls are designed for regulated research:
• ISO 27001-aligned controls
• NHS Data Security and Protection Toolkit
• Cyber Essentials certified
• regular penetration testing and vulnerability management
• encrypted data handling, access traceability and change control
QMS & Quality Control
How does AQ support quality management?
AQ integrates QMS directly with study operations:
• SOP and controlled-document management
• training and compliance tracking
• deviation and quality-event management
• CAPA workflows linked to the source record
Is CAPA integrated across AQ modules?
Yes. CAPA is connected across CTMS, eISF, ePSF and QMS. A quality finding links directly to the document or record that revealed it, and can be raised from that record. Each action is tracked with ownership, timelines and full traceability through to verified closure.
What is the CAPA lifecycle?
AQ runs CAPA through eight controlled stages, each with entry and exit conditions:
• Open — issue recorded, risk level set, owner and target date assigned
• Investigation — evidence reviewed, factual account documented
• Root cause — structured method applied (5 Whys, Fishbone or equivalent)
• Action plan — corrective and preventive actions defined, with owners and dates
• Approval — plan reviewed and confirmed proportionate to the risk (independent)
• Implementation — each action carried out and evidenced individually
• Verification — independent confirmation the action actually worked (effectiveness)
• Closure — formally closed, with final remarks on record
A CAPA closes only when effectiveness is verified. If verification finds the fix didn’t hold, the CAPA returns to action planning automatically. Nothing closes by default — only by evidence.
How does AQ track staff compliance?
AQ tracks the records that show staff are operating under current procedures:
• training completion
• document acknowledgements
• role-based requirements
• delegation and authority, via Digital DoA
How does AQ manage SOPs and training?
AQ controls SOP versions and links them to training and acknowledgements, so the right people confirm the current version. When a procedure changes, training is assigned automatically and tracked against the live SOP version. Training compliance is visible across the team in one view, and review cycles are managed by the system rather than tracked manually.
What does onboarding include?
AQ onboarding includes:
• system configuration based on your study setup
• role and permission setup
• live training sessions
• supporting documentation and tutorials
Will AQ disrupt ongoing studies during implementation?
No. AQ is introduced alongside existing workflows and transitioned in phases, so active studies continue without interruption.
Can we migrate from paper or legacy systems?
Yes. AQ supports migration from paper, shared drives and legacy systems, preserving document structure and history. The AQ team scopes your migration approach as part of onboarding.
What do you need from our team to implement?
Implementation needs your study and site setup details, your roles and permission structure, and a point of contact to confirm configuration and sign-off. AQ handles the configuration and training around your team’s availability.
Do you provide validation support for our QA team?
Yes. AQ provides validation documentation and support to QA teams as part of onboarding for regulated environments. Speak to the AQ team about what your quality system requires.
What support is available after onboarding?
AQ provides ongoing support:
• platform support
• guidance during adoption
• help with configuration updates
• user help resources
What are your support response times?
Support response times depend on your plan and the severity of the issue. Confirm current support arrangements with the AQ team.
Implementation & Support
How is AQ priced?
Pricing depends on the modules selected, the number of studies and the scale of your operations. A tailored quote is provided based on your setup — contact the AQ team for details.
Is pricing per study or per user?
Pricing reflects the modules selected, the number of studies and the scale of operations rather than a single per-seat figure. The AQ team builds a quote around your setup.
Is there a minimum commitment or contract length?
Contract terms are agreed as part of your quote. Speak to the AQ team for current options.
Can we run a pilot first?
Yes — many teams start with a single module or a focused pilot before expanding. Speak to the AQ team to scope one.
Why choose AQ over a free eISF tool?
Free eISF tools manage site documentation only. AQ connects the whole operation — CTMS, eTMF, eISF, ePSF (pharmacy and IP accountability), QMS, CAPA and Digital DoA — in one record, with native pharmacy management and CAPA-to-document linkage that point tools do not offer, and it is built for UK, MHRA and NHS research. You start with one module and expand without re-onboarding.
How can I request a demo?
Request a demo or book a consultation through the AQ website. The team will review your requirements and recommend suitable modules.
Pricing & Access
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