Clinical trials
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Costing clinical trials of ATIMPs using the NIHR iCT
11 February 2026Guidance to support and promote consistent pharmacy costing for commercial clinical trials involving ATIMPs.
Operating as an NHS clinical trial site post EU Exit
11 February 2026A summary of the implications of the UKs exit from the EU for clinical trial sites for both IMP and ATIMPs, including supply to and from Northern Ireland.
Outsourcing ATIMP storage or preparation across legal boundaries
11 February 2026Guidance on the considerations for pharmacy clinical trial sites outsourcing activities involved in the delivery of ATIMPs.
Product design considerations for optimising ATMP implementation
11 February 2026This guidance provides advice for ATMP developers, highlighting implementation challenges faced by the NHS and suggesting design consideration to minimise them.
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.
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
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.
Ex-Vivo Non-GMO Gene Therapy Medicinal Products - Pharmacy Institutional Readiness Guidance
5 November 2025This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing Ex-Vivo Non-Genetically Modified Organism Gene Therapies.
In-Vivo Non-GMO Gene Therapy Medicinal Products - Pharmacy Institutional Readiness Guidance
30 October 2025This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing In-Vivo Non-Genetically Modified Organism Gene Therapies.