Clinical trials
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Ex-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 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.
Somatic Cell Therapy Medicinal Products - Pharmacy Institutional Readiness Guidance
25 March 2025This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing Somatic Cell Therapy Product.
Ex-Vivo (cell based) GMO Gene Therapy Medicinal Products - Pharmacy Institutional Readiness Guidance
20 March 2025This 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 - Pharmacy Institutional Readiness Guidance
20 March 2025This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing In-Vivo Genetically Modified Organism (GMO) Gene Therapy.
How to undertake an audit of a cell therapy laboratory
18 February 2025A 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
7 February 2024A Template Technical Agreement for outsourcing the Receipt, Storage, Preparation and Onward Supply of ATIMPs for Clinical Trial Sites
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