- Scope of the procurement
- Lot 3. Storage of Research Drugs
- Lot 6. QP Release
- Lot 1. Manufacture of Trial Drugs
- Lot 2. Over-labelling Services (Labelling & Secondary Packaging)
- Lot 4. Distribution of Trial Drugs and Placebos to UK and/or international sites
- Lot 5. Importation of Research Drugs
- Lot 7. Trial Monitoring Services
Section one: Contracting authority
one.1) Name and addresses
University of Dundee
Procurement, 3rd Floor, Tower Building, Nethergate
Dundee
DD1 4HN
Contact
Mary Kirkpatrick
Telephone
+44 1382386684
Country
United Kingdom
NUTS code
UKM71 - Angus and Dundee City
Internet address(es)
Main address
Buyer's address
https://www.publiccontractsscotland.gov.uk/search/Search_AuthProfile.aspx?ID=AA00105
one.2) Information about joint procurement
The contract is awarded by a central purchasing body
one.3) Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at
www.publiccontractsscotland.gov.uk
Additional information can be obtained from the above-mentioned address
Tenders or requests to participate must be submitted electronically via
www.publicontractsscotland.gov.uk
Electronic communication requires the use of tools and devices that are not generally available. Unrestricted and full direct access to these tools and devices is possible, free of charge, at
www.publicontractsscotland.gov.uk
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Education
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Lotted Term Framework for the management and manufacture of research drugs including over-labelling, storage and distribution to trial sites, and associated trial monitoring services
Reference number
UoD-LAB432-TC-2023
two.1.2) Main CPV code
- 73110000 - Research services
two.1.3) Type of contract
Services
two.1.4) Short description
This Lotted Term Framework is required in order to provide a quick route to market for smaller clinical trials being conducted by Tayside Clinical Trials Unit (TCTU) in respect of the management and manufacture of research drugs, including (as necessary) over-labelling, storage and distribution , and trial monitoring services
two.1.5) Estimated total value
Value excluding VAT: £1,000,000
two.1.6) Information about lots
This contract is divided into lots: Yes
Tenders may be submitted for maximum number of lots
7
two.2) Description
two.2.1) Title
Storage of Research Drugs
Lot No
3
two.2.2) Additional CPV code(s)
- 63120000 - Storage and warehousing services
two.2.3) Place of performance
NUTS codes
- UK - United Kingdom
Main site or place of performance
Dependent on on the location of the appointed service provider(s) and clinical trial location
two.2.4) Description of the procurement
Lot 3 of the Framework - Storage
two.2.5) Award criteria
Quality criterion - Name: Project Management & Communication / Weighting: 8
Quality criterion - Name: Storage Facility Size and Location / Weighting: 8
Quality criterion - Name: Temperature Control / Weighting: 8
Quality criterion - Name: Experience of Servicing Similar Contracts / Weighting: 8
Quality criterion - Name: Audit Control and Record Keeping / Weighting: 4
Quality criterion - Name: Business Continuity/Disaster Recovery Plan / Weighting: 4
Price - Weighting: 60
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months
24
This contract is subject to renewal
Yes
Description of renewals
2 x 12 month extensions, subject to satisfactory performance and ongoing need.
two.2.10) Information about variants
Variants will be accepted: No
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
two.2) Description
two.2.1) Title
QP Release
Lot No
6
two.2.2) Additional CPV code(s)
- 73110000 - Research services
two.2.3) Place of performance
NUTS codes
- UK - United Kingdom
Main site or place of performance
Dundee but could have sites all over the UK and potentially overseas dependent on the trial.
two.2.4) Description of the procurement
Lotted Term Framework for the management and manufacture of research drugs including over-labelling, storage and distribution to trial sites, and trial monitoring services
two.2.5) Award criteria
Quality criterion - Name: Project Management & Communication / Weighting: 8
Quality criterion - Name: Proposed Methodology for QP release / Weighting: 8
Quality criterion - Name: Experience of servicing similar contracts / Weighting: 8
Quality criterion - Name: Audit Control and Record Keeping / Weighting: 8
Quality criterion - Name: Business Continuity /Disaster Recovery Plan / Weighting: 8
Price - Weighting: 60
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months
24
This contract is subject to renewal
Yes
Description of renewals
2 x 12 months subject to satisfactory performance and ongoing need.
two.2.10) Information about variants
Variants will be accepted: No
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
two.2) Description
two.2.1) Title
Manufacture of Trial Drugs
Lot No
1
two.2.2) Additional CPV code(s)
- 33600000 - Pharmaceutical products
two.2.3) Place of performance
NUTS codes
- UK - United Kingdom
Main site or place of performance
Could be anywhere in UK or overseas depending on clinical trial
two.2.4) Description of the procurement
Supply and/or Manufacture of Clinical Trial drugs on a project by project basis (service provider(s) will be appointed via Mini Competition under the relevant Lot of the Framework)
two.2.5) Award criteria
Quality criterion - Name: 1. Project Management & Communication / Weighting: 8
Quality criterion - Name: 2. Randomisation & Drug Management / Weighting: 8
Quality criterion - Name: 3. Manufacture of IMP/Placebo / Weighting: 8
Quality criterion - Name: 4. Audit Control & Record Keeping / Weighting: 4
Quality criterion - Name: 5. Experience of Servicing Similar Contracts / Weighting: 8
Quality criterion - Name: 6. Business Continuity/Disaster Recovery Plan / Weighting: 4
Price - Weighting: 60
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months
24
This contract is subject to renewal
Yes
Description of renewals
Option to extend framework for 2 x 12 months after initial 2 year term, subject to satisfactory performance and ongoing need.
two.2.10) Information about variants
Variants will be accepted: No
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
two.2) Description
two.2.1) Title
Over-labelling Services (Labelling & Secondary Packaging)
Lot No
2
two.2.2) Additional CPV code(s)
- 79824000 - Printing and distribution services
two.2.3) Place of performance
NUTS codes
- UK - United Kingdom
Main site or place of performance
Determined on a project by project basis.
two.2.4) Description of the procurement
Provision of Over-labelling Services (Labelling & Secondary Packaging) in support of smaller clinical trials being conducted by Tayside Clinical Trials Unit (TCTU), University of Dundee.
two.2.5) Award criteria
Quality criterion - Name: Project Management & Communication / Weighting: 8
Quality criterion - Name: Proposed Labelling Methodology for IMP and Placebo / Weighting: 8
Quality criterion - Name: Proposed methodology for secondary packaging of Trial drug / Weighting: 8
Quality criterion - Name: Experience of Servicing Similar Contracts / Weighting: 8
Quality criterion - Name: Audit Control and Record Keeping / Weighting: 4
Quality criterion - Name: Business Continuity/Disaster Recovery Plan / Weighting: 4
Price - Weighting: 60
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months
24
This contract is subject to renewal
Yes
Description of renewals
2 x 12 months, subject to satisfactory performance by the appointed service provider(s) and ongoing need.
two.2.10) Information about variants
Variants will be accepted: No
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
two.2) Description
two.2.1) Title
Distribution of Trial Drugs and Placebos to UK and/or international sites
Lot No
4
two.2.2) Additional CPV code(s)
- 60000000 - Transport services (excl. Waste transport)
two.2.3) Place of performance
NUTS codes
- UK - United Kingdom
Main site or place of performance
Dundee, but trial sites could be anywhere in the UK and potentially overseas.
two.2.4) Description of the procurement
This Lot relates to the distribution of Clinical Trial Drugs to participating UK and/or international trial sites.
two.2.5) Award criteria
Quality criterion - Name: Project Management & Communication / Weighting: 8
Quality criterion - Name: Available Fleet for distribution of trial drugs to UK and/or international trial sites. / Weighting: 8
Quality criterion - Name: Audit Control and Record Keeping / Weighting: 8
Quality criterion - Name: Experience of Servicing Similar Contracts / Weighting: 8
Quality criterion - Name: Business Continuity/Disaster Recovery Plan / Weighting: 8
Price - Weighting: 60
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months
24
This contract is subject to renewal
Yes
Description of renewals
2 x 12 months, subject to satisfactory performance and ongoing need by the University.
two.2.10) Information about variants
Variants will be accepted: No
two.2.11) Information about options
Options: Yes
Description of options
2 x 12 months, subject to satisfactory performance and ongoing need by the University.
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
two.2.14) Additional information
Foe detailed information, please see attached tender documents.
two.2) Description
two.2.1) Title
Importation of Research Drugs
Lot No
5
two.2.2) Additional CPV code(s)
- 79824000 - Printing and distribution services
two.2.3) Place of performance
NUTS codes
- UK - United Kingdom
Main site or place of performance
Based in Dundee but could have Clinical Trial Sites across the UK and/or abroad.
two.2.4) Description of the procurement
Lotted Term Framework for the Management and manufacture of Research Drugs.
two.2.5) Award criteria
Quality criterion - Name: Project Management & Communication / Weighting: 8
Quality criterion - Name: Proposed Methodology for over-labelling importation of Research Drugs importa / Weighting: 8
Quality criterion - Name: Experience of Servicing similar contracts / Weighting: 8
Quality criterion - Name: Audit Control and Record Keeping / Weighting: 8
Quality criterion - Name: Continuity/Disaster Recovery Plan / Weighting: 8
Price - Weighting: 60
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months
24
This contract is subject to renewal
Yes
Description of renewals
2 x 12 month extension(s), subject to satisfactory performance an ongoing need.
two.2.10) Information about variants
Variants will be accepted: No
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
two.2) Description
two.2.1) Title
Trial Monitoring Services
Lot No
7
two.2.2) Additional CPV code(s)
- 73110000 - Research services
two.2.3) Place of performance
NUTS codes
- UK - United Kingdom
Main site or place of performance
Based in Dundee but trials could be anywhere in the UK and/or overseas.
two.2.4) Description of the procurement
Lot 7 relates to Trial Monitoring Services for any Clinical trials that may require them.
two.2.5) Award criteria
Quality criterion - Name: Project Management & Communication / Weighting: 8
Quality criterion - Name: Preparation of Plan of Activity to Deliver Sponsor Monitoring Plan / Weighting: 8
Quality criterion - Name: Audit Control & Record Keeping / Weighting: 8
Quality criterion - Name: Experience of Servicing Similar Contracts / Weighting: 8
Quality criterion - Name: Business Continuity/Disaster Recovery Plan / Weighting: 8
Price - Weighting: 60
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months
24
This contract is subject to renewal
Yes
Description of renewals
2 x 12 month extensions after initial 2 year term, subject to satisfactory performance and ongoing need.
two.2.10) Information about variants
Variants will be accepted: No
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
Section three. Legal, economic, financial and technical information
three.1) Conditions for participation
three.1.1) Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registers
List and brief description of conditions
MHRA Certificate of GMP Compliance of a Manufacturer/Manufacturer's Authorisation - IMP with named Qualified Person (QP).
three.1.2) Economic and financial standing
Selection criteria as stated in the procurement documents
three.1.3) Technical and professional ability
Selection criteria as stated in the procurement documents
three.2) Conditions related to the contract
three.2.2) Contract performance conditions
As detailed in tender documents
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Open procedure
four.1.3) Information about a framework agreement or a dynamic purchasing system
The procurement involves the establishment of a framework agreement
Framework agreement with several operators
Envisaged maximum number of participants to the framework agreement: 21
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
four.2) Administrative information
four.2.2) Time limit for receipt of tenders or requests to participate
Originally published as:
Date
27 October 2023
Local time
12:00pm
Changed to:
Date
27 November 2023
Local time
12:00pm
See the change notice.
four.2.4) Languages in which tenders or requests to participate may be submitted
English
four.2.6) Minimum time frame during which the tenderer must maintain the tender
Tender must be valid until: 30 November 2023
four.2.7) Conditions for opening of tenders
Date
27 October 2023
Local time
12:00pm
Place
Electronically
Information about authorised persons and opening procedure
Mary Kirkpatrick, Category Manager, duly authorised.
Section six. Complementary information
six.1) Information about recurrence
This is a recurrent procurement: No
six.2) Information about electronic workflows
Electronic ordering will be used
Electronic invoicing will be accepted
Electronic payment will be used
six.3) Additional information
NOTE: To register your interest in this notice and obtain any additional information please visit the Public Contracts Scotland Web Site at https://www.publiccontractsscotland.gov.uk/Search/Search_Switch.aspx?ID=740555.
The buyer has indicated that it will accept electronic responses to this notice via the Postbox facility. A user guide is available at https://www.publiccontractsscotland.gov.uk/sitehelp/help_guides.aspx.
Suppliers are advised to allow adequate time for uploading documents and to dispatch the electronic response well in advance of the closing time to avoid any last minute problems.
(SC Ref:740555)
Download the ESPD document here: https://www.publiccontractsscotland.gov.uk/ESPD/ESPD_Download.aspx?id=740555
six.4) Procedures for review
six.4.1) Review body
Dundee Sheriff Court
Bell Street
Dundee
Country
United Kingdom