Controlled Pharmacy Documentation for Clinical Trial Drug Management
AQ ePSF is the electronic Pharmacy Site File for clinical research pharmacy teams. Replace paper accountability logs, dispensing diaries, and spreadsheet trackers with one structured pharmacy file for investigational medicinal product receipt, storage, dispensing, return, and destruction. Built for pharmacy research teams who need MHRA-grade IMP control without an enterprise pharmacy management platform.
FIG.01 — Live study mission control
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Pharmacy IMP accountability scattered across paper logs, Excel trackers, and locked drawers.
Most clinical research pharmacies manage investigational medicinal product accountability across paper accountability logs, departmental Excel trackers, dispensing diaries, temperature monitoring records, and physical drug storage logs — each maintained in parallel for each active study. When an MHRA pharmacy inspector or sponsor monitor asks for the complete accountability trail on IMP-014 — receipt date, storage conditions over time, dispensing records, return reconciliation, destruction certificate — the pharmacy team spends hours reconstructing it from sources that don’t reconcile.
Accountability Gaps Across Concurrent Studies
Three studies open in pharmacy. IMP-014 is in one accountability log, IMP-027 in another, IMP-031 on paper. The pharmacy lead manually reconciles the totals for the monthly QP review — and discovers the discrepancy on dispensing visit 47 that no one had flagged.
Pharmacy Role Changes Across Study Staff
A new research pharmacist starts. The handover document references "the dispensing record" without specifying which one for which study. Two weeks in, the new pharmacist signs off a dispensing record without realising it was the wrong version. The delegation log doesn't show when authorisation transferred.
Inconsistent Pharmacy File Structures
Each study's pharmacy file is structured slightly differently — depending on who set it up, when, and which sponsor's template was used. When the MHRA inspector arrives and asks for IMP-014's pharmacy file, the team has to first find which physical folder structure was used for that study.
Limited Traceability of Drug Accountability History
The accountability log shows current stock. It doesn't easily show the audit trail of receipt, storage temperature excursions, dispensing events, returns, and destructions — the chronology that an inspector or sponsor monitor reconstructs to verify IMP integrity end-to-end.
AQ ePSF: From scattered pharmacy records to one inspection-ready Pharmacy Site File
AQ ePSF gives pharmacy research teams one structured environment for every essential IMP record. Receipt logs, storage and temperature monitoring, dispensing records, return reconciliation, destruction certificates, and delegation logs — all maintained in real time, all controlled by named pharmacy users, all ready to be presented to MHRA, sponsor monitors, or QP review at any point in the study lifecycle.
Reduced Manual Record Handling
Replace paper logs and Excel trackers with one pharmacy site file. Help pharmacists avoid monthly record reconstruction and ensure all know where the dispensing diary for IMP-014 is.
Clearer Accountability Oversight
Pharmacy teams see at a glance which IMPs are in stock, which require attention, which dispensing events are pending sign-off, and which records are missing — across every active study.
Faster Record Access During Reviews
Essential pharmacy records stay organised, searchable, and presentable. Teams spend less time locating accountability records and more time on pharmacy practice. Sponsor monitor visits review records, not document logistics.
Stronger Pharmacy Inspection Readiness
MP accountability stays structured and accessible throughout the study lifecycle. The pharmacy stays close to MHRA-inspection-ready every day — not just the week before an inspection is announced.
AQ's ePSF
Core Capabilities
AQ’s ePSF is built with all the powerful features and functionalities clinical research sites, coordinators, and study teams require in one place for managing investigator site documentation across multiple clinical trials
01 — Pharmacy Templates
Pharmacy File Template Configuration
Administrators build folder and subfolder structures once, defining the complete ePSF hierarchy for a study. The selected template applies the full pharmacy file structure on study creation. Templates are editable, category-specific, and reusable across studies.
02 — File Management
Structured Pharmacy Document Filing
Folder and file structures organise pharmacy documentation across studies. Upload, version, lock, move, and restore records — receipt logs, dispensing diaries, destruction certificates — while maintaining a consistent, audit-ready pharmacy file structure.
03 — IP Accountability
Investigational Product Tracking
Pharmacy teams see exactly which IP records are filed, missing, or require attention across every active study. Stock levels, temperature logs, dispensing records, and QP review status are tracked with completeness indicators — surfacing gaps before they become inspection findings.
04 — Compliance and Audit
Document Review and Electronic Signatures
Controlled approval workflows and mandatory signing enforce compliant document authorisation. True copy certification captures a SHA-256 hash, 21 CFR Part 11 electronic signature, and generates a downloadable PDF certificate. Every document action is recorded in a full, exportable audit trail.
05 — Team Coordination
Pharmacy Team Collaboration
Pharmacists, coordinators, monitors, and sponsors collaborate directly within the pharmacy document environment. Threaded comments support user tagging, high priority flagging, and resolution tracking. Notifications and remote monitoring support keep communication connected to the relevant records.
06 — Access and Roles
User Permissions and Study Access
Role-based permissions, folder restrictions, and tree- level access management give coordinators, PIs, monitors, and sponsors precisely scoped access across every study. Restricted folders are invisible to unauthorised users. Every permission change is audited.
07 — Analytics
Dashboards and Operational Reporting
Real-time dashboards present site documentation activity, completeness metrics, and operational performance across studies. Page visit analytics, activity tracking, and study-level audit log exports give teams full operational visibility. Reports export directly to Excel.
08 — Module Connectivity
Connected Across AQ
ePSF connects directly across the AQ platform. Pharmacy documentation aligns with site records in AQ eISF, eliminating the disconnect between pharmacy and investigator files. IP accountability gaps escalate into AQ CAPA. QMS governance informs pharmacy document control. Study data, sites, and milestones sync from AQ CTMS.
How AQ ePSF Supports Controlled Investigational Product Accountability
AQ ePSF is designed to remove the hassles of manual pharmacy record
handling, accountability reconciliation, and delayed audit preparation
across clinical trials.
Doc Accountability Status
Operational indicators present investigational product record status across studies. Pharmacy teams recognise documentation gaps and accountability completeness earlier.
Organised Review Access
Structured pharmacy records support efficient monitoring, audit review, and regulatory inspection access. Authorised reviewers can easily locate required documentation.
Traceable Responsibility
Authorisation updates and accountability actions remain linked to responsible pharmacy personnel. Clear traceability strengthens governance across investigational product handling.
Operational Oversight Metrics
ePSF Dashboards present pharmacy activity metrics across studies. Oversight indicators support early recognition of accountability gaps and operational pressure.
Why Choose AQ Electronic Pharmacy Site File?
Integrated Clinical Trial Platform
AQ ePSF operates within the broader CTMS environment. Pharmacy documentation,
investigational product accountability, and study activity remain connected
across the research platform.
Structured IP
Governance
Organised oversight across pharmacy records, accountability history, and authorised pharmacy activity. Structured documentation strengthens investigational product governance across clinical trials.
Flexible Pharmacy Record Framework
AQ ePSF adapts pharmacy site file structures across protocols, sponsors, and research environments while maintaining consistent accountability documentation across studies.
Secure Documentation Environment
Role-based permissions maintain controlled access across pharmacy records. Traceable activity history supports compliance with ICH-GCP principles across all pharmacy operations.
AQ ePSF Setup, Configuration, and Adoption
AscensionQ supports research pharmacies during setup, configuration, and platform adoption — transitioning from paper logs, shared folders, and local trackers to a structured digital pharmacy documentation environment.
Onboarding
Resources
During Rollout
Support
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Here is what our Clients are saying About us
It was a very good experience
Easy to see with clear and concise viewing of the content. It updates very quickly and is useful to note any changes when samples arrive and when a cohort cancels their appointment
– Valerie P.
Research Technician
It was a very good experience
The AscensionQ platform has helped my research staff set-up multiple studies faster and manage participant appointments more effectively. The software is easy to use and the team is always there to help us.
– Fran Westwell
Lead / Senior Research Nurse
Key Questions Beyond Software Features
What is an electronic pharmacy site file (ePSF)?
An electronic pharmacy site file (ePSF) is the controlled record for research pharmacy documentation and investigational product accountability: IP receipt, storage, dispensing, returns, reconciliation, destruction, temperature logs and authorisations. AQ ePSF brings these into the same study environment as the eISF and eTMF, so pharmacy evidence is traceable, connected and review-ready rather than held in binders and spreadsheets.
How does AQ ePSF manage investigational product (IP) accountability?
AQ ePSF records IP receipt, storage, dispensing, returns, reconciliation and destruction with supporting accountability evidence in one controlled file. Temperature and storage records stay traceable against the relevant study, and dispensing and authorisation activity is logged with audit trails. Pharmacy teams can prove IP activity is complete and controlled without manual evidence-gathering.
Does AQ ePSF connect pharmacy records to the wider study?
Yes. AQ ePSF links pharmacy documentation to the eISF, eTMF, QMS, CAPA and Digital DOA on the same study record. Authorisations connect to role-based access and delegation, and pharmacy findings flow into quality workflows. Pharmacy oversight stops sitting in isolation and becomes part of connected study control.
How does AQ ePSF support pharmacy inspection readiness?
AQ ePSF maintains audit trails, activity history, evidence logs and exportable records to support sponsor, QA and MHRA review. Because pharmacy evidence is captured as work happens, accountability gaps surface in daily operations rather than under inspection pressure. Research pharmacy teams enter monitoring and inspection with documentation already current and traceable.
Do all trials need ePSF, or only those with an investigational medicinal product?
ePSF applies to trials that involve an investigational medicinal product (IMP). For an IMP study, it gives pharmacy a controlled file for documentation and accountability connected to the wider study record. Trials without an IMP can run the other AQ modules and add ePSF if pharmacy activity later requires it, so adoption stays modular.
