Notice Information
Notice Title
Supply and Manufacture of Investigational Medicinal Products (IMPs) for the Clinical Trial: "Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision"
Notice 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 Information
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.
Procurement Information
The products involved are manufactured purely for the purpose of research. In addition, Simbec-Orion is positioned to meet the requirements of the clinical trial. No other supplier was found to be able to offer the complete set of services required for this project.
Notice Details
Publication & Lifecycle
- Open Contracting ID
- ocds-kuma6s-147495
- Publication Source
- Sell2Wales
- Latest Notice
- https://www.sell2wales.gov.wales/search/search_switch.aspx?ID=147495
- Current Stage
- Award
- All Stages
- Award
Procurement Classification
- Notice Type
- OJEU - F15 - Voluntary Ex Ante Transparency Notice
- Procurement Type
- Standard
- Procurement Category
- Goods
- Procurement Method
- Limited
- Procurement Method Details
- Award procedure without prior publication of a call for competition
- Tender Suitability
- Not specified
- Awardee Scale
- SME
Common Procurement Vocabulary (CPV)
- CPV Divisions
33 - Medical equipments, pharmaceuticals and personal care products
-
- CPV Codes
33000000 - Medical equipments, pharmaceuticals and personal care products
Notice Value(s)
- Tender Value
- Not specified
- Lots Value
- Not specified
- Awards Value
- Not specified
- Contracts Value
- £116,645 £100K-£500K
Notice Dates
- Publication Date
- 20 Jan 20251 years ago
- Submission Deadline
- Not specified
- Future Notice Date
- Not specified
- Award Date
- 1 Jan 20251 years ago
- Contract Period
- Not specified - Not specified
- Recurrence
- Not specified
Notice Status
- Tender Status
- Complete
- Lots Status
- Complete
- Awards Status
- Not Specified
- Contracts Status
- Active
Buyer & Supplier
Contracting Authority (Buyer)
- Main Buyer
- NHS WALES SHARED SERVICES PARTNERSHIP (NWSSP) - PROCUREMENT SERVICES
- Contact Name
- Nia Price
- Contact Email
- nia.price@wales.nhs.uk
- Contact Phone
- +44 2921501500
Buyer Location
- Locality
- CARDIFF
- Postcode
- CF14 4HH
- Post Town
- Cardiff
- Country
- Wales
-
- Major Region (ITL 1)
- TLL Wales
- Basic Region (ITL 2)
- TLL5 South East Wales
- Small Region (ITL 3)
- TLL52 Cardiff and Vale of Glamorgan
- Delivery Location
- TLL22 Cardiff and Vale of Glamorgan
-
- Local Authority
- Cardiff
- Electoral Ward
- Heath
- Westminster Constituency
- Cardiff North
Further Information
Notice Documents
-
https://www.sell2wales.gov.wales/search/show/search_view.aspx?ID=JAN497192
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.
Open Contracting Data Standard (OCDS)
View full OCDS Record for this contracting process
The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.
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