From study setup to final handover, AQ gives academic research teams one place to organise study files, prepare participating sites, assign responsibilities and learning, and follow up quality actions — so every study is set up consistently and handover is never lost.
Each study brings its own arrangements, teams and systems. Select a challenge to see how AQ handles it.
An investigator-led study, a multicentre collaboration and a no-visit study require different arrangements — and teams rebuild them from scratch each time.
Define the study structure, participating teams, expected documentation and responsibilities that apply to that study.
Documents, approvals and follow-up sit with different departments, institutions or participating sites. Nobody holds the whole picture.
Each team sees the studies, folders and responsibilities relevant to its work, with sponsor, investigator and site information kept separate.
Participant data stays in REDCap or an EDC, finance in an institutional system, analysis with a statistics team. The operational record has no home.
AQ is that home: study documentation, site coordination, training, responsibilities, quality actions and handover.
Researchers, coordinators and fellows move between studies or leave the institution, taking study knowledge with them.
Incoming staff find the current documents, see their responsibilities, complete required learning and take over outstanding work.
A concern is not resolved simply because it has been recorded.
Actions are assigned with owners and due dates, the history of decisions is preserved, and formal CAPA is available when required.
Your operating model depends on the study you are running, the responsibilities your institution holds and the teams involved. Choose the study type your team runs.
Create the study and participating teams. Organise applicable protocols, approvals and supporting documents, define expected documents and configure visits where the study includes scheduled participant activity.Assign study roles and record delegated activities. Provide access to the appropriate study areas, assign required procedures and learning, and track missing site documentation.Track expected documents by participating team, identify outstanding approvals or site records, review current and superseded versions, and give collaborators access to the information they need.Maintain participant records, track recruitment activity, coordinate appointments, record attendance and changes, and allocate staff and locations in CTMS. Studies without scheduled visits do not need to use this workflow.Control procedure versions, assign learning and review completion. Record investigator delegation changes in Digital DoA (Digital Delegation of Authority), investigate issues, assign corrective actions and verify whether they were effective.Transfer document ownership, update access, review outstanding work and confirm required learning. Retain document history and agree export and continued-access arrangements.
Configure access around the work each person performs and the records they are authorised to review.
Review study documentation, delegated responsibilities and operational progress within their remit.
Study oversightSet up studies, coordinate participating sites, follow up outstanding documentation and prepare progress reviews.
Assigned studiesMaintain assigned study activity, participant follow-up and local documentation where applicable.
Assigned sitesReview study evidence, responsibilities and quality information across the studies they oversee.
Sponsor remitMaintain controlled procedures, assign learning and manage formal quality actions.
Organisation-wideManage pharmacy documentation where pharmacy activity forms part of the study.
Pharmacy fileInternal permissions and external sponsor or CRO access are managed separately — administrators assign external users to specified studies, sites and folders, and update or withdraw access as assignments change.
AQ does not require your institution to move every research activity into one platform.
Study structure, responsibilities and operational documentation.
Funding, contracts, sponsorship acceptance and ethics processes.
Recruitment follow-up, appointments, attendance, source forms and samples where required.
Research data capture, analysis and statistical systems.
Sponsor, investigator, site or pharmacy files according to responsibility.
Institutional repositories where applicable.
Controlled documents, learning and quality actions.
Organisation-wide systems that remain outside the study.
Operational evidence, document history and handover.
Grant accounting, publication, impact reporting and data repositories.
Use AQ for the operational work your academic teams need to coordinate. Keep research data, finance, analysis, safety, laboratory and publication activity in the systems already selected for those purposes. Define the required exchange with your institutional IT team.
AQ supports study operations, documentation, delegation, training and quality workflows. It can work alongside REDCap, EDC and other research data systems. It is not a replacement for participant-level data capture, statistical analysis or data repositories.
AQ can support the operational responsibilities your institution holds, including study documentation, participating teams, quality workflows and access management. The configuration depends on whether your institution acts as sponsor, coordinating unit, participating site or a combination of these.
No. Select modules according to the work the study actually involves. A study without scheduled visits may not need CTMS Planner. Pharmacy documentation, sponsor-file management, investigator-file management and delegation workflows are also conditional.
Yes. AQ can sit alongside your existing research data, finance and institutional systems. Any integration or data exchange should be defined according to your institution’s technical and governance requirements.
Access, document ownership, learning requirements, delegated activities and outstanding work can be reviewed as responsibilities change. Completed study records retain their history for later review, reporting and retention.
Bring your study design, team structure, participating sites and current systems. We will show the AQ workflows relevant to your institution.
Practical walkthroughs aligned with active research delivery.
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✓ Written for first-in-human & Phase 1 sites
✓ Inspection-ready checklists & templates
✓ Aligned to MHRA, FDA & EU Annex 11