Does AQ replace our EDC, safety or specialist clinical trial systems?

No. AQ is designed to work alongside the systems already used by your sponsors, sites and specialist teams. EDC, safety, randomisation, finance and other specialist applications can remain in place while AQ supports the documentation, quality, access and operational workflows that sit around them. Where information needs to move between applications, API integration can be scoped around your requirements.

Can sponsors and sites have different levels of access in AQ?

Yes. AQ supports controlled access for different study participants. Sponsor and CRO users can be given access to selected studies, sites and folders, while site teams retain responsibility for their own investigator and pharmacy documentation. Permissions can be reviewed, changed or withdrawn as responsibilities change.

How does the AQ sponsor portal manage users and study access?

AQ’s sponsor portal allows authorised sponsor users to access the study information relevant to their responsibilities. Administrators can create or manage sponsor and CRO accounts, assign access to named studies, sites and folders, and adjust or withdraw permissions when required. Access should be configured according to the agreed study workflow and information-sharing requirements.

How does AQ support protocol amendments and study changes?

AQ supports the documentation and coordination work created by a protocol amendment or other study change. Teams can manage revised documents, relevant learning assignments, delegation records, pharmacy documentation and site follow-up where applicable. Regulatory submissions, EDC changes, safety-system updates, participant communication and re-consent remain with the responsible sponsor, investigator and specialist teams.

For contract research organisations

Keep complex studies moving
from setup to closeout.

AQ helps contract research organisations organise study start-up, site delivery, sponsor-file work and quality follow-through in the workflows they own. Add site-file, pharmacy and delegation workflows when your service scope requires them.

See how AQ works for CROs

Core — every CROWhere the organisation holds that scope

On this page

The CRO operating pressure

Fragmented study operations make clinical trial delivery difficult to coordinate.

Study set-up, site activation, participant delivery, sponsor reporting and quality follow-up rarely sit with one team. When every handoff depends on a separate tracker or application, delays become difficult to see and expensive to correct.

The cost of disconnected handoffs

People re-enter information, chase confirmations and reconcile files across systems that do not communicate with one another.

Where the study slows down

Study start-up is difficult to coordinate

Requirements, sites, staff, milestones and essential documents are managed across different teams and systems.

Site progress is difficult to monitor consistently

Contract research organisations need to compare recruitment, screen failures, site readiness and follow-up requirements across participating sites.

Sponsors receive fragmented and delayed information

When updates are assembled from separate systems, important issues may reach the sponsor only after they have affected delivery.

Protocol amendments and deviations create additional work

A study change can affect documentation, training, delegation, pharmacy requirements, participant communication and site implementation.

The questions contract research organisations answer daily

Move from study status to the action behind it.

Select a question to open the workflow where the relevant evidence, responsibility and follow-up are managed.

The questionWhere the answer is worked

Select a question to open the workflow where that work is coordinated.

The CRO study delivery workflow

See how AQ supports study coordination from setup through closeout.

Explore the operational views used to organise study documentation, follow up site requirements, coordinate protocol changes and provide sponsors with controlled access to agreed evidence.

View 1 · Set up the study

Establish the study structure before delivery begins.

View 1 / 6

Create the study and site structure, organise expected documentation, configure access and prepare the procedures and learning assignments required for the work ahead.

Active in this view

CTMSeTMFQMS

Add when the scope requires it

eISFPharmacyDigital DoACAPA

aq-trials.com/ctms/study-setupCRO VIEW

Operational outcomes

Every request is issued, tracked and evidenced.

Select a moment in the study to see the follow-up, approvals and evidence AQ handles, and the outcome it produces.

Study activityAQ-2411 · Site 04Live

OutcomeLess manual follow-up

Coverage across the operational span

Each category of application covers part of the operational span.

Contract research organisations assemble study evidence across several applications. This is the span each category of software typically covers, and where the work passes to something else.

Categories are illustrative. Individual products vary, and several are used together on the same study.

Access across CRO teams

Study information aligned with each team’s responsibilities.

Configure access to the studies, sites and records each team needs for its work — from study setup and documentation review to quality follow-up and sponsor oversight.

TeamWorks onAccess

CRO leadership and operationsDelivery status, scope changes, resourcing and sponsor commitments.Authorised studies

Study start-upStudy and site structure, access and expected documentation.Assigned studies

Clinical operationsRecruitment against expectation and site follow-up.Assigned studies

TMF and regulatory operationsExpected documentation, filing status and handover.Trial file

Quality and complianceProcedures, learning, quality actions and verification.Organisation-wide

Site and pharmacy reviewersInvestigator and pharmacy documentation for their own site.Permitted folders

Coexistence

Existing study applications remain in place.

CROs rarely operate a study through one application. Sponsor-mandated and other study applications continue to manage the activities they are designed for, and integration is scoped only where information genuinely needs to move.

Data capture and database management

EDC configuration, database builds, query management and database lock.

Safety reporting

Case processing, signal management and expedited reporting.

Randomisation

Treatment allocation and randomisation management.

Finance, contracts and resourcing

Budgets, contracting, invoicing, utilisation and financial reporting.

Data analysis and laboratory applications

Statistical programming, analysis environments and laboratory systems.

Where information must move between applications, integration is scoped around the study's requirements, the permissions involved and validation responsibilities. No connection is assumed.

Assurance and compliance

The evidence your quality, IT and sponsor teams request before approval

Validation, data security, data protection and residency documentation, available to contract research organisations and their sponsors on request.

21 CFR Part 11ICH-GCPALCOA+Cyber EssentialsG-Cloud

ValidationIQ, OQ and PQ documentation provided on request.On request

Data securityNHS DSPT, Cyber Essentials Plus and G-Cloud.Certified

Data protectionUK GDPR, DPIA pack and data processing agreement.Provided

Data residencyUK-hosted, with the provider named on request.UK

Audit historyDocument actions, access decisions and signatures recorded.Exportable

FAQs

Questions contract research organisations ask before introducing new clinical trial software.

A CRO needs software that supports the responsibilities it has been contracted to deliver, including study setup, site documentation, recruitment oversight, quality follow-up, delegation and sponsor reporting. AQ can be configured around those responsibilities, so CROs can use the relevant modules without replacing every system already used by their sponsors or sites.

Your operating model

Show us how your organisation runs a study.

We will map your start-up, site delivery, documentation and quality workflows to the AQ views that support them.

Also built forNHS / Hospital Academic Research Sponsors SMOs and site networks

Keep complex studies moving
from setup to closeout.

Fragmented study operations make clinical trial delivery difficult to coordinate.

Move from study status to the action behind it.

See how AQ supports study coordination from setup through closeout.

Every request is issued, tracked and evidenced.

Each category of application covers part of the operational span.

Study information aligned with each team’s responsibilities.

Existing study applications remain in place.

The evidence your quality, IT and sponsor teams request before approval

Questions contract research organisations ask before introducing new clinical trial software.

Show us how your organisation runs a study.

Request a live AQ workflow walkthrough.

BOOK A DEMO

Request a Guided AQ Tour

Fragmented study operations make clinical trial delivery difficult to coordinate.

Move from study status to the action behind it.

See how AQ supports study coordination from setup through closeout.

Every request is issued, tracked and evidenced.

Each category of application covers part of the operational span.

Study information aligned with each team’s responsibilities.

Existing study applications remain in place.

The evidence your quality, IT and sponsor teams request before approval

Questions contract research organisations ask before introducing new clinical trial software.

Show us how your organisation runs a study.

Request a live AQ workflow walkthrough.

BOOK A DEMO

Request a Guided AQ Tour

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