Inspection readiness maintained as a daily state.

The controlled repository for site-level study documentation: protocol versions and amendments, regulatory and ethics approvals, consent forms, delegation of authority, training records and monitoring evidence. It is the site’s own record of how it conducted the study, and the file examined during a site inspection. AQ eISF builds it from a template, establishes each expected document as a tracked placeholder with a due date and named owner, and holds every version, signature and action on one permanent audit trail.

The trial master file is the sponsor’s record of the trial. The investigator site file is the site’s record of its own conduct. UK regulation provides for both and allows the two to hold different content. A site filing into a sponsor’s eTMF retains its obligation to hold and evidence its own investigator site file, and an inspection of a site examines the site’s file.

Each required document exists as a placeholder with a due date calculated from the study reference date, so the file reports at any point what is fulfilled, pending, overdue or waived, by site and by milestone. Owners are notified ahead of a due date and escalated thereafter, and phase advancement waits until every item is cleared.

Fulfilled placeholders divided by applicable placeholders. Applicable is everything the study expects at its current phase, less any placeholder waived with a recorded reason. Both calculations display on the dashboard alongside the figures.

AQ is listed on the Digital Marketplace under G-Cloud, where pricing, service definition and exit terms are published. Procurement is a framework call-off rather than a full tender. Pricing reflects the modules adopted and the scale of the operation, so a quotation is prepared against your configuration. A trial period is available on a case-by-case basis.

Those systems address different requirements. The list of documents a study is expected to produce, the calculation of when each falls due, and a defensible readiness figure sit outside all three, which is why parallel spreadsheets are maintained alongside them. AQ eISF replaces the spreadsheets.

Connected Intelligence organises records, proposes where an upload belongs, surfaces documentation gaps and detects quality signals early. Every suggestion is reviewed by an individual. Authority over signature, certification, record closure and phase advancement rests with the responsible user, and the readiness figure is calculated from filed and waived placeholders. UK-hosted and aligned with NHS DSPT expectations.

Yes. A reviewer is established as a study-scoped user with access to the sites and folders to which they are entitled, reviewing the current version in its filed position. Restricted folders remain visible only to named users, and every access is attributable.

Yes. One template may be applied across every site, or a distinct template and reference date assigned per site. The cross-site matrix presents every site against the same milestones, and phase advancement waits until the outstanding list is cleared at all of them.

The same controls applied to different files. eISF holds the investigator site file. ePSF holds the pharmacy site file — investigational product accountability, dispensing logs, storage temperature records, cold-chain verification and calibration. A study may run both, each from its own template.