Supply and Manufacture of Investigational Medicinal Products (IMPs) for the Clinical Trial: "Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision"

Description

Cardiff and Vale University Health Board (CAVUHB) is undertaking a clinical trial entitled ‘Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision’, funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme (Ref: NIHR 160872). As part of this clinical trial, an Investigational Medicinal Product (IMP) needs to be manufactured and distributed. Lot 1: Supply and Manufacture of Investigational Medicinal Products (IMPs) for the Clinical Trial: "Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision" Cardiff and Vale University Health Board (CAVUHB) is undertaking a clinical trial entitled ‘Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision’, funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme (Ref: NIHR 160872). As part of this clinical trial, an Investigational Medicinal Product (IMP) needs to be manufactured and distributed. The IMPs required are: -Flucloxacillin 2 x 500mg capsules, over encapsulated -A matching placebo of inert filler, over encapsulated to match flucloxacillin 2 x 500mg capsules. The successful supplier will be responsible for the manufacture, packaging, labelling, Quality Assurance (QA) certification, storage, shipment, and regulatory compliance (CTIMP regulations) associated with the trial’s IMPs. After extensive market research and consultations with multiple suppliers, it has been concluded that only one supplier, Simbec-Orion, has the capability to fulfil the full scope of the contract requirements. This includes: -Over encapsulation of flucloxacillin and matching placebo -Packaging and labelling of the final product -Compliance with clinical trial regulations (CTIMP) -Storage and shipment logistics to participating NHS sites -QA certification and regulatory compliance for blinded clinical trials Simbec-Orion will also source the bulk IMP (4 lots of flucloxacillin, 1 lot of placebos), over encapsulate the product, and ensure all necessary documentation and quality assurance procedures are met. Simbec-Orion is uniquely positioned to meet the requirements of the clinical trial due to its established capabilities in the manufacture and regulatory compliance of Investigational Medicinal Products (IMPs). No other supplier was found to be able to offer the complete set of services required for this project.