Notice Information
Notice Title
One -off Contract for the Supply of Drug Handling Services for the trial Sotagliflozin in Patients with Heart Failure Symptoms and Type 1 Diabetes (SOPHIST)
Notice Description
One off Contract for the Over Labelling, Storage & Distribution of Research Drugs to Clinical Trial Sites in the UK.
Lot Information
Lot 1
The objective of this procurement is to appoint a single Service Provider for the import, secondary labelling commercially supplied IMP tablets and matching placebo tablets, and their onward distribution to trial sites, as detailed below: -Importer of Record: act as importer of record to the UK. -IMP and placebo to be provided by Patheon (Thermo Fisher Scientific) Canada, on behalf of Lexicon. Both will be supplied in 100ml HDPE containers, induction sealed with Child Resistant Cap. Each container will have 90 tablets, either IMP or placebo, and will be individually labelled and packaged. One container is required per participant for the duration of the trial (i.e. one dispensing of one container to each participant). -IMP is Sotagliflozin 200mg, once daily versus matched placebo. -Number of participants - Target recruitment is 320 participants -Number of sites and countries: UK: 12 sites Overseas: None -Labelling: Total number of containers: Approx 400 containers, shipped into the UK in one or two shipments from manufacturer. Over label containers: (IMP and placebo), over labelling to be done at 15-25oC Labelling options: Single panel label in English on each container. -QP release and distribution: QP release and ship IMP/placebo to up to 12 UK study sites, sites to be confirmed. Two shipments per site: approximately 20 containers (to be confirmed) in the first shipment, second shipment to sites depending on recruitment rates of each site. Distribution to at 15-25oC, with temperature monitor. -Storage 24 months at 15-25oC for active trial period -IMP dossier Appointed Service provider to provide an abbreviated IMP dossier for submission to the MHRA
Notice Details
Publication & Lifecycle
- Open Contracting ID
- ocds-r6ebe6-0000728720
- Publication Source
- Public Contracts Scotland
- Latest Notice
- https://www.publiccontractsscotland.gov.uk/search/show/search_view.aspx?ID=JUN481454
- Current Stage
- Award
- All Stages
- Tender, Award
Procurement Classification
- Notice Type
- PCS Notice - Website Contract Award Notice
- Procurement Type
- Standard
- Procurement Category
- Services
- Procurement Method
- Open
- Procurement Method Details
- Open procedure
- Tender Suitability
- Not specified
- Awardee Scale
- SME
Common Procurement Vocabulary (CPV)
- CPV Divisions
33 - Medical equipments, pharmaceuticals and personal care products
60 - Transport services (excl. Waste transport)
63 - Supporting and auxiliary transport services; travel agencies services
73 - Research and development services and related consultancy services
79 - Business services: law, marketing, consulting, recruitment, printing and security
-
- CPV Codes
33600000 - Pharmaceutical products
60000000 - Transport services (excl. Waste transport)
63120000 - Storage and warehousing services
73110000 - Research services
79824000 - Printing and distribution services
Notice Value(s)
- Tender Value
- £66,000 Under £100K
- Lots Value
- £66,000 Under £100K
- Awards Value
- Not specified
- Contracts Value
- Not specified
Notice Dates
- Publication Date
- 19 Jun 20232 years ago
- Submission Deadline
- 10 May 2023Expired
- Future Notice Date
- Not specified
- Award Date
- 14 Jun 20232 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
- UNIVERSITY OF DUNDEE
- Contact Name
- Mary Kirkpatrick, Category Manager
- Contact Email
- hthomson001@dundee.ac.uk, m.y.kirkpatrick@dundee.ac.uk
- Contact Phone
- +44 1382386604, +44 1382386810
Buyer Location
- Locality
- DUNDEE
- Postcode
- DD1 4HN
- Post Town
- Dundee
- Country
- Scotland
-
- Major Region (ITL 1)
- TLM Scotland
- Basic Region (ITL 2)
- TLM0 Eastern Scotland
- Small Region (ITL 3)
- TLM03 Angus and Dundee City
- Delivery Location
- Not specified
-
- Local Authority
- Dundee City
- Electoral Ward
- West End
- Westminster Constituency
- Dundee Central
Further Information
Notice Documents
-
https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=APR475865&idx=4
20th April 2023 - Annex C - Pricing Schedule UoD-LAB477-OO-2023 -
https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=APR475865&idx=9
20th April 2023 - Annex C - Pricing Schedule UoD-LAB477-OO-2023 -
https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=APR475865&idx=3
20th April 2023 - Annex B - Quality Schedule UoD-LAB477-OO--2023 -
https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=APR475865&idx=8
20th April 2023 - Annex B - Quality Schedule UoD-LAB477-OO--2023 -
https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=APR475865&idx=2
20th April 2023 - Annex A - UoD-LAB477-OO-2023 -
https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=APR475865&idx=7
20th April 2023 - Annex A - UoD-LAB477-OO-2023 SoR and Special Conditions MB 19-04-23 -
https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=APR475865&idx=1
10th April 2023 - Master ITT - UoD-LAB477-OO-2023 -
https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=APR475865&idx=5
10th April 2023 - Annex D - Terms and Conditions -
https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=APR475865&idx=6
10th April 2023 - Annex D2 - Front End to TsCs - Supply of Services -
https://www.publiccontractsscotland.gov.uk/search/show/search_view.aspx?ID=APR475865
One -off Contract for the Supply of Drug Handling Services for the trial Sotagliflozin in Patients with Heart Failure Symptoms and Type 1 Diabetes (SOPHIST) - One off Contract for the Over Labelling, Storage & Distribution of Research Drugs to Clinical Trial Sites in the UK. -
https://www.publiccontractsscotland.gov.uk/search/show/search_view.aspx?ID=JUN481454
One -off Contract for the Supply of Drug Handling Services for the trial Sotagliflozin in Patients with Heart Failure Symptoms and Type 1 Diabetes (SOPHIST) - One off Contract for the Over Labelling, Storage & Distribution of Research Drugs to Clinical Trial Sites in the UK.
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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