Clinical trials
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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.
Ex-vivo GMO gene therapy medicinal products
13 February 2026This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing ex-vivo genetically modified organism (GMO) gene therapy.
In-vivo GMO gene therapy medicinal products
13 February 2026This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing in-vivo genetically modified organism (GMO) gene therapy.
Tissue engineered products
13 February 2026This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing tissue engineered products.
Ex-vivo non-GMO gene therapy medicinal products
13 February 2026This 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
13 February 2026This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing in-vivo non-genetically modified organism gene therapies.
Somatic cell therapy medicinal products
13 February 2026This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing somatic cell therapy product.
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.
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.