Clinical trials
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Undertaking an audit of a cell therapy laboratory
11 February 2026A guide to performing audits of cell therapy laboratories where receipt, storage and handling of cell-based ATMPs has been outsourced by the pharmacy department
Outsourcing ATIMP handling: A template technical agreement
11 February 2026A template technical agreement for outsourcing the receipt, storage, preparation and onward supply of ATIMPs for clinical trial sites.
Updated clinical trials regulation: implementation considerations
26 February 2026An SPS Quality Assurance learning event on understanding the updated clinical trials regulation and practical considerations for pharmacy clinical trials sites.
Supply of aseptically prepared IMPs across legal boundaries
19 November 2025The legal and practical implications when transferring aseptically prepared Investigational Medicinal Products (IMPs) across legal boundaries.
The role of the sponsor pharmacy in clinical trials of investigational medicinal products (CTIMPs)
21 November 2024Identifying key areas where pharmaceutical expertise is required by sponsors for conducting non-commercial clinical trials
Supporting funding applications for CTIMPs
21 November 2024Sponsor pharmacy role in funding applications and establishing costs for sponsor activities
Pharmacy manual checklist for clinical trials for ATIMPs
2 March 2023Pharmacy manual content expectations for optimal site implementation of ATIMP clinical trials.
Closing clinical trials
12 December 2022Sponsor pharmacy responsibilities during trial closure and the final monitoring visit
Monitoring and auditing clinical trials by participating sites
12 December 2022An overview of the Sponsor Pharmacy's responsibilities for monitoring and auditing a clinical trial as part of participating site management
Constructing a pharmacy manual for clinical trials
12 December 2022Sponsor pharmacy must construct a pharmacy manual when required by sites hosting clinical trials