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
AQ
Sponsor access
Sponsor access. Admin · Sponsor/CRO management. Core — every CRO. CRO controls. Grant sponsor reviewers access by study, site and folder, with an expiry date. Every grant, change and withdrawal is logged.Access by study, site and folder, with an expiry date. Every change logged.
Procedures and training
Procedures and training. QMS. Core — every CRO. CRO operates. One current version in circulation. Learning assigned against the released version and evidenced per individual.One current version in circulation. Completion evidenced per individual.
Trial file
Trial file. eTMF. Core — every CRO. CRO operates. The sponsor-level file, structured against expected content.The sponsor-level file, structured against expected content.
Quality events
Quality events. CAPA. Core — every CRO. CRO operates. Investigation, actions and effectiveness verification through eight defined stages.Investigation, actions and effectiveness verification.
Site file
Site file. eISF. Core — every CRO. Site maintains · CRO reviews. Study binders, placeholders and milestones. Reviewer access is scoped to the folders granted.Study binders and milestones. Review access scoped to the folders granted.
Delegated authority
Delegated authority. Digital DoA. Core — every CRO. Site owns · CRO reviews. Who held authority for which activity, on which study, and when.Who held authority for which activity, and when.
Pharmacy file
Pharmacy file. Pharmacy. Where the organisation holds that scope. Site pharmacy maintains · CRO reviews. Pharmacy documentation and accountability records, shared to the folder level.Pharmacy documentation and accountability, shared to folder level.
Study delivery
Study delivery. CTMS · Planner and Participant Manager. Where the organisation holds that scope. Site executes · CRO monitors. Feasibility, recruitment and screening. Oversight reporting including out-of-window and deviation. Visit booking sits with the site.Feasibility, recruitment, screening and oversight reporting. Booking sits with the site.
Source forms
Source forms. eSource. Where the organisation holds that scope. Site operates · CRO reviews. Controlled source forms, released with a recorded reason. Review access is scoped to the studies granted.Controlled source forms, released with a recorded reason.
Lab samples
Lab samples. Labs. Where the organisation holds that scope. Site operates · CRO reviews. Every trial sample accounted for, from collection to reconciliation, with manifests available for review.Every trial sample accounted for, from collection to reconciliation.
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 studyView 2 · Follow up site readinessView 3 · Review recruitmentView 4 · Coordinate amendmentsView 5 · Provide sponsor accessView 6 · Prepare closeout
Establish the study structure before delivery begins.Identify what each site still needs before it can proceed.Monitor recruitment performance across participating sites.Coordinate the work created by a protocol amendment.Give sponsors controlled access to agreed study evidence.Reconcile the file and prepare the study handover.
View 1 / 6View 2 / 6View 3 / 6View 4 / 6View 5 / 6View 6 / 6

Create the study and site structure, organise expected documentation, configure access and prepare the procedures and learning assignments required for the work ahead.Review outstanding documentation, training evidence, delegation records and applicable pharmacy requirements. Use the available evidence to focus follow-up with the appropriate site teams.Review recruitment against expectations, screen failures and the timeliness of site updates. Use these insights to identify where follow-up or escalation may be required.Manage revised documents and relevant training requirements. Review delegation and pharmacy records where affected, and follow up the evidence required for implementation at each site.Provide authorised sponsor reviewers with access to the studies, sites, folders and documentation relevant to their responsibilities.Review outstanding documents and unresolved queries, prepare the agreed export and audit history, and update access as responsibilities move into closeout and archive.

Participant communication and re-consent are managed by the responsible sponsor and investigator teams where required.

Active in this view
CTMSeTMFQMS
eISFPharmacyDigital DoAeTMFQMS
CTMS reporting and participant data where available
QMSeTMFeISFDigital DoA
AdmineTMFeISFPharmacy
eTMFeISFAdmin
Add when the scope requires it
eISFPharmacyDigital DoACAPA
CTMSCAPA
eTMFQMSCAPA
PharmacyCAPA
CTMSQMSCAPADigital DoA
PharmacyQMSCAPADigital DoA
aq-trials.com/ctms/study-setupaq-trials.com/eisf/site-readinessaq-trials.com/ctms/recruitmentaq-trials.com/qms/amendmentsaq-trials.com/admin/sponsor-accessaq-trials.com/etmf/closeoutCRO VIEW
Study structure
12
Sites attached
9/14
Milestones set
Study structure complete82%
Expected documents defined64%
Outstanding before delivery
Insurance certificate · Site 04due 12 Jun
Staff learning · Site 07assigned
Schedule not confirmed · Site 11owner set
Access configured · project teamcomplete
Readiness evidence
9/12
Sites ready
3
Awaiting signature
Documentation complete75%
Training evidence83%
Pharmacy requirements60%
Requiring follow-up
Delegation not signed · Site 04assigned
Curriculum vitae · Dr A. Whitfieldnot provided
Laboratory certificate · Site 11expires 30 Jun
Essential documents · Site 02complete
Recruitment against expectation
18/25
Recruited
9
Screen failures
Northgate General88%
Warrington74%
Surrey52%
Timeliness of site updates
Northgate General · updated 2 days agocurrent
Warrington · updated 6 days agocurrent
Surrey · updated 16 days agofollow-up
Escalation raised · Surreywith site
Revised documentation
3
Revised documents
2
Sites outstanding
Learning completed69%
Binder expectations updated75%
Evidence for implementation
Protocol v4.0 · released to 3 sitesreleased
Participant information sheet v3with site teams
Protocol v4.0 learning assignment18 of 26
Delegation update · sub-investigatorawaiting sign-off
Scope of access
2
Reviewer accounts
3/7
Folders shared
Studies · AQ-2411 Phase IIin scope
Sites · Northgate, Warrington2 of 3
Regulatory · Site staff · Pharmacypermitted
Access management
Expiry applied · 31 Dec 2026set
Grants, amendments and withdrawalslogged
Reviewer qualification evidencecurrent
Administration screensnot available
Handover readiness
98%
Records filed
2
Open queries
Final review complete88%
Archive readiness88%
Before handover
Outstanding records6 items
Query · missing visit log pageopen
Export package assembledready
Audit historycomplete
AI assist
Drafts the study structure, expected documents and milestone dates from the protocol for your team to confirm.
Review & confirmEditaudit-trailed
AI assist
Lists the missing records, signatures and training items per site so follow-up can be directed to the right team.
Review & confirmEditaudit-trailed
AI assist
Names the sites behind expectation and the updates that have not been provided within the agreed reporting period.
Review & confirmEditaudit-trailed
AI assist
Lists the documents, learning assignments and delegation records affected by the amendment, by site.
Review & confirmEditaudit-trailed
AI assist
Summarises what each reviewer account can open, and what has changed since the last review of permissions.
Review & confirmEditaudit-trailed
AI assist
Names every outstanding record and unresolved query standing between the study and archive readiness.
Review & confirmEditaudit-trailed
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
Document requestSite 04 · delegated duties log
Request issued to the siteAssigned to J. Okafor, site coordinator09:12
Reminder scheduled automaticallyIssues in 3 working days if unansweredAuto
Signed log received and filedSite file · section 3 · version recorded11:40
Essential documents filed at Site 0411 of 12
Protocol v4.0 distributionReleased 5 Jun 2026
Northgate GeneralFiled 6 Jun
WarringtonFiled 6 Jun
SurreyAcknowledgement due
St ElmswoodAcknowledgement due
Learning completed against v4.018 of 26
Signature requestDigital DoA · AQ-2411
Sent toDr A. Whitfield · principal investigator
SubjectDr M. Farrow · sub-investigator
Duties delegated4 selected from the study list
StatusAwaiting signature · sent 14:20
SignQueryaudit-trailed

Required learning is assigned to the named individual when the delegation is signed.

CAPA-0042Stage 5 of 8 · within service level
OPEN
2
3
4
5
6
7
CLOSE
OwnerA. Reyes · quality lead
Due30 June 2026
Linked procedureSOP-07 v3 · released
VerificationEffectiveness check scheduled
Sponsor reviewer scopeArdenmoor Therapeutics
StudiesAQ-2411 · Phase II
SitesNorthgate General, Warrington · 2 of 3
FoldersRegulatory, Site staff, Pharmacy · 3 of 7
Documents visible128 current versions
Expiry31 December 2026
Access decision written to the study log · 16:31 · A. Reyes
Pharmacy file setupConfigured for this study
Pharmacy site file createdNorthgate General · pharmacy
Pharmacy contact invitedAccess scoped to the site only
Manual acknowledgementOutstanding · due 24 Jun 2026

Pharmacy documentation remains with the site and is visible to the organisation where access has been granted.

OutcomeLess manual follow-upMore controlled changeA clearer path to activationEarlier visibility of riskSponsor-ready reportingA configuration that fits the service
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.

Legacy dispersed software
01
Study
setup
02
Site
readiness
03
Recruitment
oversight
04
Trial
documentation
05
Quality
follow-up
06
Sponsor
evidence
Where it hands over
Trackers and spreadsheetsManual coordination
Status recorded, then reconciled by hand
Document repositoriesFiled documents
Holds the filed version
Learning systemsTraining records
Completion held against a course
Sponsor platforms and portalsSponsor-mandated
Scoped to the sponsor’s own study systems
AQAQOne connected record
Documents, training, delegation and quality — one audit trail
Connected across the spanTypically coveredContinues in another application

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 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.

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.

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.

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.

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.

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 / HospitalAcademic ResearchSponsorsSMOs and site networks
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01The workflows your organisation owns, view by view
02A real change, end to end, with the audit trail
03Configuration, access model and your timeline
21 CFR Part 11ICH-GCPALCOA+Cyber EssentialsG-Cloud
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