Keep trial documentation and quality follow-up under review.
Manage essential trial files, controlled procedures and corrective actions in AQ. Give sponsor teams the evidence they need to review partner delivery and follow up outstanding work.
Know what is outstanding before the next study review.
Partner updates need supporting records, current procedures and clear follow-up. AQ helps your team review the documentation and quality work within its scope.
Review the records behind each stage of the study.
Explore sponsor-file management, authorised document review, procedure changes and quality follow-up — from setup through closeout.
Establish the files and procedures your team will use.
Organise expected trial documents, assign document responsibilities and configure authorised access. Use QMS for the controlled procedures and learning managed by your sponsor team.
Contract negotiation and vendor qualification are not illustrated; they remain in your existing processes.
Review site evidence without changing who is responsible for it.
Investigators and pharmacy teams maintain their own records. Authorised sponsor and CRO reviewers receive access to the studies, sites and document folders agreed for their work.
Reviewer access is granted per study, site and folder, with an end date. Document access does not infer participant-level access. ePSF scope applies only where pharmacy work is in review.
Every AQ module is available. Your responsibilities decide how you use them.
AQ covers trial documentation, procedures and quality, study operations, and site, pharmacy and delegation workflows. Sponsors adopt the modules that match the work their organisation holds.
The AQ platformAll seven modules are available. How your team uses each one depends on your responsibilities.Maintain essential trial files, control procedures and learning, and follow formal quality actions through verification.
Manage study and site activity where delivery is conducted in AQ, with reporting available within the agreed access scope.
Support investigator files, pharmacy documentation and delegated site duties, with relevant evidence available for authorised sponsor review.
Assess the workflow, implementation and assurance requirements together.
Review the functions your team will use, the records that need to move and the controls your organisation requires before agreeing the deployment scope.
Confirm workflow fit.
Demonstrate the sponsor, CRO and site responsibilities relevant to your studies.
Plan the transition.
Define migration, interfaces, user access, training and implementation responsibilities.
Review assurance and retention.
Assess validation, security, hosting, audit history, export and continued-access requirements.
Questions from sponsor teams.
Yes. Agree which sponsor workflows are managed in AQ, which partner records your reviewers may access and how evidence from other systems will be supplied.
