One controlled pharmacy record, across every study you run.
AQ Pharmacy is clinical trial pharmacy software for research sites. It records each investigational medicinal product (IMP) kit from receipt into quarantine through release, storage, dispensing, return, reconciliation and destruction. Required forms must be completed and approved before stock moves to the next step, and the clinical trial pharmacy site file is kept in the same module.
What does the pharmacy see each morning?
Before the first dispense of the day, the inventory view shows the position of stock for the selected study and site.
Where does control of trial medicine break down?
A trials pharmacy runs many studies at once, each with its own sponsor, allocation system and forms. The difficulty is rarely the work itself. It is keeping several records of the same stock in agreement.
How does AQ Pharmacy manage a trial medicine?
Set-up defines what the site will receive. The ledger records every movement of stock. The evidence is produced as each step is completed.
How does AQ Pharmacy prevent errors before they happen?
Most pharmacy records show what happened after the event. In AQ Pharmacy, the controls sit at the point of action. A kit cannot move to the next step until the step before it is complete and approved.
For each study, the pharmacy decides which forms are required, who completes them, who approves them and how quickly.
In AQ Pharmacy, received stock stays in quarantine until a named person approves the receipt checklist and releases it.
How does one kit move through the pharmacy?
This example follows a single kit of a refrigerated, blinded study medication. Names and numbers are illustrative.
How is the evidence produced?
In AQ Pharmacy, the record of each step is created by the step itself. Staff do not complete the work and then write it up separately.
When a monitor or inspector asks for the history of a kit, the record already exists.
What does the clinical trial pharmacy site file hold?
AQ Pharmacy includes the electronic pharmacy site file (ePSF): the controlled file of pharmacy documents for each study. It is kept separately from the investigator site file and is organised in nine fixed sections.
Pharmacy binderStudy 001 · Site AThe site sees the label. Never the treatment.
Each blinded product carries a site-facing label. Staff see that label on every kit; the treatment behind it stays hidden through receipt, storage and dispensing. If a participant’s care requires it, that one participant can be unblinded.
How does AQ Pharmacy work across sponsors and studies?
The sponsor’s allocation system belongs to the sponsor and covers one study. The hospital pharmacy system records routine stock. AQ Pharmacy is the site’s own record of every trial medicine, across every study and every sponsor.
Which system holds which part of the pharmacy record?
AQ Pharmacy works alongside the systems a trials pharmacy already uses. Each has a different responsibility.
How does AQ Pharmacy connect with the rest of AQ Platform?
AQ Pharmacy can be bought on its own or with other AQ modules. Each module is priced and deployed independently.
What changes for each member of the team?
Pharmacy technician
Records each receipt, dispense and return once, in one place. The due forms list shows what needs completing today.
Chief Pharmacist
Approves releases, prescriptions and reconciliations before stock moves. Each approval is attributed and locked.
R&D or QA manager
Sees the stock position and form status for each study, with the history of every kit available for audit.
Monitor or sponsor
Reviews accountability remotely, with forms and supporting documents already filed by section.
Questions clinical trial pharmacy teams ask.
An inspector checks that the pharmacy can show the history of every investigational medicinal product it has handled: receipt and release, storage and temperature records, dispensing against prescriptions, returns, reconciliation and destruction, with delegation, training and procedures in place. A clinical trial pharmacy site file is the site's record for a study, not a wholesaler's Site Master File. In AQ Pharmacy, these records sit in nine fixed sections, with the ledger history behind them.
Not covered here? Write to us at enquiries@aq-trials.com.
Clinical trial pharmacy guides.
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