We already run a site CTMS such as RealTime, CRIO or Clinical Conductor. Where does AQ fit?

AQ adds the quality and evidence layer across your sites: controlled SOPs, training, delegation, site and pharmacy files, and CAPA. Your existing system keeps scheduling, finance and data capture. The implementation plan sets which records live where.

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 holds content the sponsor has delegated.

What moves between systems, and what stays manual?

Documents come into AQ by upload, including bulk upload. Reports, registers and audit logs export to Excel or PDF for sponsors and inspectors. Data entry into sponsor EDC and IRT stays in those systems. Any further data exchange is scoped per study during implementation.

Who is responsible for what: the SMO, the investigator or the host?

The investigator decides and signs each delegation and keeps oversight. The SMO answers for the procedures, training and qualifications of the staff it supplies. The host institution sets local arrangements. AQ records each party’s evidence. The responsibilities themselves come from your contracts and agreements.

How is a new site brought onto our 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.

Can we see recruitment and study progress by site?

Yes. CTMS shows screening and enrolment against target, visit schedules and capacity for each site, and the same view rolls up across your network.

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 start-up

Site files

Pharmacy files

Delegated duties

SOPs and training

Findings and CAPA

TMF content

Two operating models

Your own sites or staff placed in hospitals. One record of who is trained and authorised.

SMOs work in two ways, and many do both. Sponsors and investigators expect the same proof either way: every person on the study follows current procedures, holds valid training and works within delegated duties.

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% Illustrative data

Running your own research sites

New openings and acquisitions arrive with their own habits. AQ applies your SOPs, file templates and role model to each site from day one, and shows which sites have procedures and training in force.

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.

Illustrative data

Placing coordinators in host institutions

Your staff work inside hospitals run by someone else. AQ holds your procedures, training records, qualifications and delegation evidence for every placed person, within the arrangements agreed with each host.

Investigator accountability

The investigator stays responsible for the work your staff perform.

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) Investigators may delegate trial activities, and keep responsibility for them and for oversight of the people they rely on.

An SMO is judged on the evidence it can produce for each person, site and study.

The work behind every site

Seven pressures that grow with each new site and study.

For each pressure, the current approach and how AQ replaces the manual work involved.

Sites in your network Repeated at each site Handled once in AQ

Pressure Today With AQ Modules

01Study start-up and site activation Start-up documents chased by email; activation dates slip site by site Repeated at 6 sites Expected documents and milestones tracked per site, with blockers named Once, for all 6 sites CTMS eISF

02Protocol amendments across sites New versions emailed; filing and retraining tracked on spreadsheets Repeated at 6 sites Amendment filed once, training assigned, acknowledgement tracked per site Once, for all 6 sites eISF QMS

03Manual, duplicated tasks Logs, trackers and reports rebuilt by hand for each site and sponsor Repeated at 6 sites One record per study; reports filtered from it and exported Once, for all 6 sites Platform

04Staff turnover and delegation Delegation logs rebuilt on paper each time a coordinator joins or leaves Repeated at 6 sites Duties signed by the PI and linked to current training Once, for all 6 sites Digital DoA QMS

05Recruitment against target Screening counts gathered site by site at month end Repeated at 6 sites Screening and enrolment against target visible by site Once, for all 6 sites CTMS

06Monitoring visit readiness Files checked and findings chased in the week before the visit Repeated at 6 sites File completeness and open findings visible before the monitor arrives Once, for all 6 sites eISF Pharmacy

07Deviations that repeat across sites Logged in local spreadsheets; the same cause returns at another site Repeated at 6 sites One CAPA record with actions and effectiveness checks across sites Once, for all 6 sites CAPA

Change control across sites

A new version counts once the staff who follow it are trained.

Protocol amendments and SOP revisions pass through four stages before an SMO can show they are in force at every site. Each hand-off between unconnected systems is where a site falls behind.

Stage Shared drives and email Document system alone Training 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 outstandingIllustrative data

Monitoring and audit What a sponsor monitor or auditor asks for, answered the same way at every site. Each request maps to one place in AQ, so every site produces its evidence from the same source. Illustrative data

SOPs in force and training evidence

41 / 48 7 due staff trained on SOP-QA-014 v4

QMS Library · Reporting

Persons delegated and their duties

18 Current delegations signed by the PI

Digital DoA

Site and pharmacy file status

94% On track site file complete · Site 02

eISF · Pharmacy

Recorded activity

2,316 Retained entries recorded this month

Audit Log

Deviations and corrective actions

3 of 4 Verifying actions closed · CAPA-0016

CAPA

TMF content, where delegated

96% 2 in QC filed against TMF RM

eTMF

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

Site 02

Site 03

Site 04

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.

Where AQ fits

AQ works alongside the systems your sponsors and hosts require.

Documents come into AQ by upload, and reports and registers export for sponsors and inspectors. Any further data exchange is scoped per study.

AQ Platformconnects with Upload into AQ Export from AQ

Sponsor EDCExport Visit and participant reports

IRT / RTSMUpload Dispensing and accountability records

Sponsor eTMFExport Site documents for transfer

Safety systemsUpload Event reports filed to the site file

FinanceExport Visit costs and participant payments

Host health recordsUpload Certified source documents

Questions from SMOs

Questions SMO leadership teams ask.

Yes. An SMO can start with the modules that address its biggest pressure, for example QMS and Digital DoA for training and delegation, or eISF for site files, then add sites and modules over time. Users, roles and sites are set once in Admin, so each new module uses the same set-up.

Next step

See one of your workflows run across your sites.

Pick the workflow that costs your team the most time. We run it in the live platform against your operating model: owned sites, placed staff, or both.

Bring a new site onto your SOPs Roll out a protocol amendment Prepare a site for a monitoring visit

You leave with a clear view of how AQ handles that workflow at your sites and which modules it needs.

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.