Pharmacy software for clinical trials, from delivery to destruction certificate.

Products.

Each product is defined once for the study, with its code, name, dosage form, route, strength, storage range and storage instructions. Products can be imported from Excel.

Active, placebo or comparator.

Each product is assigned as active, placebo or comparator, with the label the site will see on the kit.

Batches and kit numbers.

Each batch and its expiry date is mapped to the kit numbers it contains, by typing, scanning with a phone or pasting a list.

Storage units.

Each storage unit is set up with its location, temperature range and racks.

Receive.

The delivery, its condition, the temperature on arrival, the shipment reference and supporting documents such as the delivery note. The stock enters quarantine.

Release.

A named person releases the stock to available once the receipt checklist has been approved.

Store.

Each kit is held in a named storage unit and rack. Temperature readings are recorded against the unit, and readings outside its range are flagged as excursions automatically.

Dispense.

A specific kit is dispensed to an enrolled participant at a visit, against an approved prescription form.

Return.

Participant returns are held for review. Unused stock returned to the sponsor is recorded separately.

Reconcile.

The physical count is compared with the expected stock for each batch. Any difference is recorded as a discrepancy.

Destroy.

The reason, method, certificate or reference and supporting evidence are recorded for each kit destroyed.

Raised by each event.

Receiving, dispensing and reconciling stock each raise the forms the study requires, linked to the transaction that raised them.

Raised on schedule.

Recurring forms, such as a daily temperature log for each storage unit, are created on schedule and assigned to a role.

Locked once approved.

Approved forms are locked, and every record keeps its full audit history.

Quarantine until released.

Stock stays in quarantine until the receipt checklist is approved and a named person releases it.

Quarantine until released.

Stock stays in quarantine until the receipt checklist is approved and a named person releases it.

Prescription approved first.

No kit is issued until the prescription is approved and checked against the protocol visit.

Prescription approved first.

No kit is issued until the prescription is approved and checked against the protocol visit.

Form approved to complete.

A count cannot close until its form is approved. Any difference is logged as a discrepancy.

Form approved to complete.

A count cannot close until its form is approved. Any difference is logged as a discrepancy.

A resupply shipment of three kits arrives. The transit logger reads 4.4 °C, within the 2 to 8 °C range, and the seals are intact. The technician records the delivery and places the kits in Pharmacy Fridge 1, rack 3. The batch is short-dated, so it is noted for first use.

The kits stay in quarantine until the accountability log for the receipt is completed and approved. The pharmacist then releases them to available stock.

At Visit 1, the research physician completes the prescription form and the pharmacist approves it after checking it against the protocol. Kit K-0118 is dispensed to participant P-042.

On the ward, the prepared syringe is left out of the fridge for about two hours and forty minutes, reaching 23.8 °C. It is not administered. The ward returns it, the pharmacy records a participant return, and the kit is held for review and labelled not for use.

The sponsor issues a return authorisation. The kit is shipped back for destruction under that reference, and the pharmacy records a stock return.

At the monthly count, the physical stock is compared with the expected stock. The counts agree, and the reconciliation form is approved.

When the sponsor’s destruction certificate arrives, it is filed in the Destruction section of the pharmacy site file.

Raised by the event

Receiving, dispensing and reconciling stock each raise the forms the study requires, linked to the transaction that raised them.

A role completes, a role approves, with a deadline

Each form has a role that completes it, a role that approves it and a deadline. Recurring forms, such as a daily temperature log for each storage unit, are created on schedule and assigned to a role. Reminders are sent by email when a form is due and when it is overdue.

Completed by the person who did the work

The record of each step is created by the step itself. Staff do not complete the work and then write it up separately.

Locked once approved

Each form records who opened, completed, submitted and approved it, and when. Its answers are locked after approval.

The history of every kit

Every movement of stock is recorded with the person, the time and the reason. The audit history of each record can be exported to Excel.

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.

Record each kit rather than a running quantity, with every movement attributed to a person and time. Record temperatures against each storage unit and act on readings outside range straight away, holding affected stock until a decision is made. In AQ Pharmacy, readings outside a unit’s range are flagged automatically, and returned kits are held for review before any further use.

On arrival, the pharmacy checks the shipment, the transit temperature and the paperwork, then holds the stock in quarantine. It is released for use only when the receipt checks are complete and any confirmation the sponsor requires has been given. In AQ Pharmacy, received stock stays in quarantine until a named person approves the receipt checklist and releases it.

Record each participant return against the kit dispensed and hold it until it is reviewed. Reconcile the physical stock against the record regularly and investigate any difference. Destroy stock only with the sponsor’s written authorisation, and keep the certificate. In AQ Pharmacy, returns are held for review, any reconciliation difference is recorded as a discrepancy, and destruction records the reason, method and certificate.

The investigator decides whether a participant’s care requires unblinding, and that decision should not wait for sponsor approval. The pharmacy follows the study’s procedure, reveals the treatment for that participant only and records who requested it, when and why. In AQ Pharmacy, blinding is applied at the point of dispensing, and an emergency unblinding can be carried out for the participant concerned.

Yes. The sponsor’s IRT allocates kits to participants and manages resupply for its study. AQ Pharmacy is the pharmacy’s own record of what it received, held, dispensed, returned and destroyed, across every study at the site. The two work side by side.

Yes. EDGE and similar systems manage study set-up and approvals, and the hospital pharmacy system manages routine stock and labels. AQ Pharmacy manages the trial medicine itself once the study is open. AQ integrates with EDGE.

The electronic pharmacy site file is part of AQ Pharmacy. It holds the pharmacy’s documents for each study. AQ Pharmacy adds the ledger that records every kit, the forms that control each step, and blinding at the point of dispensing.

Yes. Sponsor monitors can be given remote access to review accountability and the supporting records, so less of a monitoring visit is spent reconciling logs on site.

Each AQ module is priced and deployed independently, so AQ Pharmacy can be bought on its own or with other modules. Pricing is quoted for each organisation, and every quote starts with a free first consultation. Onboarding, training and support are included.