The group has been operating since March 2013 providing a non-sterile manufacturing, assembly, repackaging and blind labelling service to NHS Lothian and the University of Edinburgh investigators. In this period the ISG has successfully supported over 30 clinical trials and other investigations, many of which are on-going. In 2018 the ISG came under the management of the Healthcare Technology Accelerator Facility (HTAF) to support its on-going translational medicine platform activities. The ISG is based in George Square in central Edinburgh, where a purpose built, non-sterile, GMP suite and warehouse is established and is licensed by the MHRA. MIA (IMP) and MS licences (Specials) are held. The ISG can directly support research by primary manufacturing, packaging and assembling medicines for use in clinical trials and investigations as indicated in the scope of services below. With the experience of its staff the ISG can also provide advice at the study design/project build stage, support IMPD development, ensuring formulation, blinding and product stability issues are appropriately addressed and provide direction on outsourcing options, should these be required. Scope of services: Importation of Investigational Medicinal Products (IMPs) The manufacture of placebo capsule and powder in bottle formulations Over-encapsulate tablets and capsules (for blinding) Manufacture liquids for internal or gels for external use Design and print labels for all study phases Over-label, package and assemble investigational supplies QP Certify IMP for CTIMPs Store investigational product in a temperature controlled environment (including refrigerated and frozen -20°C) Despatch (via courier) to UK/EU clinical sites This article was published on 2022-09-29
