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Set up the study.
A visit schedule built once in Study Management is the schedule every site books against. Rules check each visit as it is entered, so an invalid schedule cannot be saved.
Average set-up for UK commercial trials fell to 122 days, against a 150-day target.
The schedule follows the approved protocol. AQ does not write the protocol or capture clinical data.
Add Study, Edit Study, Add Edit Schedule and Change Status are separate permissions.
Authorise the study team.
Access to a study is granted through one sequence: study, site, folders, then people. Each delegated duty is held beside the CV, GCP certificate and training that qualify the person for it.
Connected Intelligence suggests, prepares and organises trial work. A named person confirms every action.
The MHRA graded as critical a case in which data management staff “had data edit rights to the trial eCRF and were not delegated this activity by the investigator”.
AQ records who is authorised for each task. The principal investigator decides every delegation.
72 permissions in 7 groups. A role’s permissions apply to everyone who holds that role.
Release a procedure to every site.
When a procedure changes, the new version has to reach every site and every person who works to it. AQ carries the release from approval to evidenced training, and shows what remains outstanding.
EMA inspectors recorded 22 major findings on procedures in 2024, including “lack of version control and change management”.
AQ does not write the procedure or decide who has to train. The quality lead sets the audience.
Each review, approval and publication carries a name and a time.
Build the site file.
Each investigator site file is built from one template, so a monitor finds each document in the same place at every site. Expected documents appear as placeholders before they arrive.
Essential documents were the largest sub-category of EMA inspection findings in 2024, with 41 findings.
The list of required documents comes from the sponsor or the unit. AQ holds the structure.
18 site-file permissions, with separate folder rights and a separate Audit Log permission.
Keep the pharmacy file.
The pharmacy file follows the same structure as the investigator file and is limited to pharmacy staff. Temperature and accountability logs are filed where a monitor expects them.
The MHRA graded as critical “a lack of overall accountability of IMP received, dispensed and returned”.
AQ is not an interactive response technology (IRT) system. Drug supply and randomisation remain with the sponsor’s system.
The same 18 site-file permissions, applied folder by folder.
Release the source forms.
Source worksheets are often revised in a word processor, and printed copies of earlier versions stay in clinic folders. In AQ eSource each form is laid out on an A4 canvas, tested in preview and published with a recorded reason, and the released version is read-only.
ICH E6(R3) calls for source records that are attributable, legible, contemporaneous, original, accurate and complete.
AQ eSource controls the source forms. Recording participant data against a visit is outside the current release.
Every create, save, publish and new-draft action is in the audit log, with filters and Excel export.
Recruit and book participants.
Candidates are identified, contacted and booked against rooms, staff and visit windows in one place. A clash or an out-of-window date is shown before the booking is saved.
Phase III protocols average 119 deviations each, affecting about a third of participants.
The hospital’s patient administration system remains the patient record. AQ holds the research visit.
10 Planner and 4 Participant Manager permissions; booking, cancelling and rescheduling are granted separately.
Track each sample to its result.
When collection and processing times are written up after the event, it is hard to show a sample met the study’s limits. In AQ Labs a booked visit sets the samples due, and each handling step is recorded with the person, the time and the place.
ICH E6(R3) expects the handling of samples to follow the protocol and the laboratory’s instructions, with records that show it.
Laboratories keep their own portals and systems. AQ Labs does not assess clinical significance.
Signing a result review and releasing a sample after an excursion each require re-authentication.
Resolve deviations.
When the same finding appears at more than one site, it is investigated once and corrected at every site. A CAPA closes only after the correction has been shown to work.
The MHRA found corrective actions from two previous inspections “continued to be ineffective”.
Whether a deviation is a serious breach, and its notification, remain the sponsor’s decision.
5 CAPA permissions, with separate access to the audit log and to removed CAPAs.
Prepare for monitoring.
Before a monitoring visit, the site sees which documents are missing, who owns each one and when it is due. The milestone plan shows what each stage of the study requires.
EMA inspectors recorded 35 major monitoring findings in 2024, including “missing ISF documents” that monitoring had not detected.
File completion measures what has been filed. It does not judge the quality of each document.
Milestone Library, Milestone Plan and Generate Certification are separate permissions.
Reconcile to the master file.
Site documents reach the trial master file as the study runs, and are checked for quality on arrival. Close-out then starts from a reconciled file.
The MHRA graded as critical a sponsor master file with “insufficient documentation… to demonstrate appropriate oversight of the UK investigator sites”.
Where a sponsor requires its own eTMF, that system remains the master file.
Each filing, check and return carries a name, a time and a reason.
Oversee the portfolio.
File completion, training, recruitment and quality are compared across sites and studies on one screen. Connected Intelligence points to where attention is needed, and a named person decides what happens next.
Sponsors were responsible for 9 of the 11 critical findings EMA inspectors recorded in 2024. ICH E6(R3), the International Council for Harmonisation’s revised GCP guideline, has applied in the UK since 28 April 2026.
Connected Intelligence suggests. It does not send, close or change a record.
Reports follow each user’s permissions; sponsor and CRO users see only their assigned studies, sites and folders.
Questions buyers ask.
Going live, validation, data and procurement, answered before the demonstration.
The same tour, run on real studies and sites.
A 30-minute session follows the chapters selected above, in the same order. It ends with an agreed module scope and next steps.
This tour is illustrative. The screens are simplified illustrations of the AQ Platform, shown with sample data and fictional sites. They are not screenshots of the live software. To see the real platform on your own studies, request a demo.
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Thirty minutes on your own studies — documentation, study activity, quality processes and pharmacy, in one governed record.
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