Can one SMO manage studies for several sponsors?

Yes. Sponsor and CRO accounts are administered apart from site staff, and each is assigned only to the relevant studies, sites and folders.

Does AQ replace the sponsor’s EDC, IRT or eTMF?

No. Sponsor-mandated systems remain the record for the purposes the sponsor defines. AQ holds the SMO’s operational record, and its eTMF serves content the sponsor has delegated.

Does AQ support SMOs that place coordinators within host institutions?

Yes. The platform maintains the SMO’s procedures, training records and delegation evidence for placed staff. Each host institution’s arrangements and investigator approvals are defined during implementation.

How is a new site brought into the organisation’s standards?

The central team registers the site in Admin, creates its site files from existing templates, assigns roles and allocates the controlled SOPs. Staff then complete their training in My Learnings.

Does AQ manage sponsor invoicing?

No. Study configuration records visit costs and participant payments. Sponsor invoicing and payment reconciliation remain within the organisation’s finance systems.

Where is data hosted?

Hosting and data location are agreed during technical review.

For SMOs and site networks

Central oversight of study delivery, documentation and quality across every site.

Meet recruitment commitments, maintain staff readiness and manage sponsor-specific requirements with AQ Platform, from site activation through participant follow-up.

Book a demo Discuss a multi-site roll-out

Study · Planner · Participant Manager

Investigator site files

Pharmacy site files

Delegated study duties

Controlled SOPs and training

Findings and closure evidence

Delegated TMF content

Two operating models

Owned research sites and coordinator placement carry the same obligation to evidence delegated work.

Central quality team SOPs File templates Role model

Site AOpened 2019 SOPs in force100% Staff trained98% Site BAcquired 2023 SOPs in force100% Staff trained91% Site COpening Nov 2026 SOPs in force86% Staff trained64%

Organisations operating dedicated research sites

Site networks that expand through new openings and acquisitions. AQ brings each additional site onto the organisation’s SOPs, file templates and role model, with study-specific requirements applied within those controls.

SMO teamEvidence held in AQ Procedures QMS Training records QMS Delegation evidence DoA Qualifications and CVs eISF

Places

Host institutionNot operated by the SMO AMA. MorenoResearch coordinator Trained Delegated GCP valid JKJ. KaurResearch nurse · joined Sep Trained PI sign-off due Local arrangements and investigator approvals agreed with the host.

SMOs placing coordinators within host institutions

Coordinators working inside hospitals and clinics the SMO does not operate. The SMO’s procedures, training records and delegation evidence for the staff it places are held in AQ, within the responsibilities agreed with each host institution.

Three readers Three priorities.

Heads of quality Controlled SOPs, training and CAPA in one structure.

Heads of operations Validated schedules, visits and recruitment by site.

Site directors Site file and delegation ready for monitoring.

The full AQ platform

Every module, on one administered platform.

Each module covers a distinct part of multi-site delivery. Users, roles, studies and sites are set once in Admin and apply across all of them.

Sites and accounts

Module in use

Connected Intelligence

Site 01 · Leeds

Site 02 · Wakefield

Site 03 · Bradford

Site 05 · Harrogate

Host institution

Sponsor and CRO accounts

StudyStudy configurationLive

NR-221 visit windows validated at entry

Screening visit set on or before Day 0

Schedule readiness86%

Connected Intelligence · Visit 6 window overlaps visit 7 at two sites.

Illustrative data

Admin · administered once, applied everywhere Users Roles Sites Departments Capacity Sponsor and CRO accounts

Implementation follows the sequence agreed during onboarding.

The demands of multi-site delivery

Seven demands that grow with every site and study.

Each demand, how it is handled today and how AQ handles it.

Demand Today With AQ Modules

01 Procedures at every site SOPs emailed; old versions stay in use Released once, old version withdrawn, training tracked QMS

02 Qualified, authorised staff Paper logs rebuilt at every staff change Duties signed by the PI, beside training records Digital DoA QMS

03 Common file structure Each site builds its own file Site and pharmacy files from one template eISF ePSF

04 Multi-site study set-up Configured separately at each centre Schedules, visits and costs validated at entry Study

05 Local visits and recruitment Diaries and lists clash on the day Booked against rooms, staff and capacity Planner Participant Manager

06 Deviations with evidence Spreadsheets; recurrence goes unnoticed Findings, actions and closure in one record CAPA

07 Reconciled TMF content Reconciled only at close-out Held beside the eISF, checked at filing eTMF

Investigator accountability

The investigator remains responsible for the work an SMO performs.

Supports SMO Contract, SOPs and training evidence for the staff it supplies.

Supplies staff

Accountable Principal investigator Decides each delegation and keeps oversight of every delegated activity.

Delegates

Performs Delegated staff Qualified, trained and authorised for the duties assigned.

ICH E6(R3)Section 2.3Investigators may delegate to supplied staff but retain responsibility and a record of delegation.

US FDAGuidance 2009 · III.A.4.aInvestigators confirm SMO staff are qualified and trained, and oversee the records they keep.

Japan GCPOrdinance Art. 39-2A written contract defines how the institution verifies work performed on its behalf.

What regulators converge on An SMO is assessed on the evidence it can produce for each individual, location and study.

SOP change control across sites

A revised SOP takes effect when the staff expected to follow it are trained.

A single revision passes through four stages before an organisation can demonstrate that it is in force. Each transfer between unconnected systems creates a point at which a site falls behind.

Stage Shared drives and email Document system alone Learning system alone AQ

01 Reviewed and approved

02 Released, previous version withdrawn

03 Training and knowledge check assigned

04 Training completion reported

ExampleSOP-QA-014 v4 · 48 staff assigned 41 complete · 7 outstanding

What a sponsor auditor requests

The same evidence, requested at every site.

Shared templates and roles present each category in the same structure, whichever site is under review.

Auditor requests

Found in AQ

SOPs in force and training evidence QMS Document Library and QMS Reporting

Persons delegated and their duties Digital DoA

Site file and pharmacy file status eISF and ePSF Dashboard and Reports

Recorded activity Audit Log

Deviations and corrective actions CAPA reports and CAPA audit log

Trial master file content, where delegated eTMF

Integrations

Connected to the systems each sponsor specifies.

AQ PlatformSMO operational record Sponsor systems stay the record for their purpose. Each integration is scoped per study. 6 connections

Sponsor EDCVisit and participant status

IRTRandomisation and dispensing

Sponsor eTMFDocument transfer

Safety systemsEvent notification

Clinic recordsParticipant identification

FinanceVisit costs and payments

Questions from SMOs

Questions from SMOs and multi-site research organisations.

The complete platform: Study, Planner, Participant Manager, eISF, ePSF, eTMF, Digital DoA, QMS and CAPA, administered through Admin. The implementation sequence is agreed during onboarding.

Next step

See the platform follow a study from configuration to sponsor review.

A tailored demonstration covers study set-up, SOP release and training, delegation, site and pharmacy files, corrective actions and trial master file content, using the live platform and the organisation’s operating model.

Book a demo Take the 3-minute product tour

See how the modules connect on the AQ Platform overview, read published case studies, or compare AQ for CROs and sponsors.