The Clinical Trials Pharmacy Team is based within the main inpatient pharmacy at University Hospital Southampton, one of the UK’s most prestigious teaching hospitals. We play a critical role in supporting clinical research by ensuring the safe, compliant, and efficient handling of investigational medicinal products (IMPs).

Our facilities are purpose-built to meet the demands of modern clinical trials and include:

Ambient storage areas with controlled environmental conditions
A walk-in refrigerator unit designed to accommodate multiple studies requiring cold-chain storage
-20°C and -80°C freezers for temperature-sensitive products
Calibrated electronic temperature monitoring systems with real-time alerts
Dedicated dispensing areas under appropriate storage conditions
Dedicated quarantine areas for all storage specific areas
Secure, access-controlled storage and preparation zones

Our infrastructure supports a wide range of studies, from early-phase trials to large-scale, multi-centre investigations. Our facilities allow for good segregation of IMP’s, separate from normal pharmacy stock and with restricted access.

What We Offer

1. IMP Management

Procure, receipt, storage, and accountability of IMPs and non-IMPs (when appropriate)
Temperature-controlled storage with continuous electronic monitoring (with back-up power and back-up temperature monitoring system)
Labelling, re-labelling, and packaging in line with protocol and regulatory standards
Dispensing under appropriate storage conditions
Manage recall or drug alerts of IMP’s

2. Regulatory Compliance & Quality Assurance

Full adherence to Good Clinical Practice (GCP), Regulatory Bodies (MHRA) HRA, NIHR, NHS and local (UHS) guidelines
Support for monitoring, audits, inspections, and regulatory documentation
Robust traceability and documentation for all study drug handling (as required)

3. Trial Setup & Operational Support

Pharmacy feasibility assessments for new studies
Input into protocol development and trial logistics for UHS sponsored studies
Collaboration with sponsors, CROs, and research teams to ensure smooth trial delivery
Dedicated CT aseptic team preparing electronic documentation and IMP assembly within a clean room environment.
Lead Pharmacy team for CRDC Wessex trials.

4. Patient-Focused Services

Timely and accurate dispensing of IMPs to support patient treatment schedules
Support for blinded and open-label trials
Support unblinding service/process (when appropriate)
Safe handling, reconciliation and destruction of returned or unused IMPs
Ensure confidentiality and security of information and data regarding subjects/ clinical trials are respected and maintained.

5. Team Qualifications & Experience (with specialist training in clinical trials and GCP)

Registered Pharmacists experienced in IMP handling, study risk assessment; screening and accurate checking of trial prescriptions and study specific documentation development and maintenance
Accredited Pharmacy Technicians experienced in IMP handling, dispensing and accurate checking of trial prescriptions and study specific documentation development and maintenance
Clinical Trials Administrators experienced in IMP Management (procurement, receipt, destruction); support monitoring visits, access IMP storage areas within clinical areas and study folder maintenance
Qualified QA and Regulatory Support Staff ensuring compliance with all relevant standards
Ongoing professional development through NHS, NIHR, and sponsor-led training
Proven experience supporting Phase I–IV trials within all UHS specialities (including oncology, rare disease and ATIMP studies)