Planning

Clinical Evaluation

  • Secretary of State for Health and Social Care acting as part of the Crown through UK Health Security Agency

F01: Prior information notice (prior information only)

Notice identifier: 2024/S 000-003291

Procurement identifier (OCID): ocds-h6vhtk-04362d

Published 1 February 2024, 8:55am



Section one: Contracting authority

one.1) Name and addresses

Secretary of State for Health and Social Care acting as part of the Crown through UK Health Security Agency

10 South Colonnade

London

E14 4PU

Contact

UKHSA Commercial Operations

Email

ProcurementNotices@ukhsa.gov.uk

Country

United Kingdom

Region code

UKI42 - Tower Hamlets

Internet address(es)

Main address

https://www.gov.uk/government/organisations/uk-health-security-agency

Buyer's address

https://www.gov.uk/government/organisations/uk-health-security-agency

one.3) Communication

Additional information can be obtained from the above-mentioned address

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

https://health-family.force.com/s/Welcome

one.4) Type of the contracting authority

Ministry or any other national or federal authority

one.5) Main activity

Health


Section two: Object

two.1) Scope of the procurement

two.1.1) Title

Clinical Evaluation

two.1.2) Main CPV code

  • 73000000 - Research and development services and related consultancy services

two.1.3) Type of contract

Services

two.1.4) Short description

Delivery of evaluation studies relating to In Vitro Diagnostic devices (IVDs) or pathogen characterisation.

two.1.5) Estimated total value

Value excluding VAT: £2,500,000,000

two.1.6) Information about lots

This contract is divided into lots: No

two.2) Description

two.2.3) Place of performance

NUTS codes
  • UK - United Kingdom

two.2.4) Description of the procurement

The UK Health Security Agency (UKHSA) wishes to inform the market of their intention to undertake preliminary market engagement in advance of any potential future procurement to source one or more Clinical Research Organisations (CRO) or equivalent organisations who have the capability and experience of operational delivery of evaluation studies relating to In Vitro Diagnostic devices (IVDs) or pathogen characterisation.
This will include amongst other things protocol development, re-kitting and distribution of diagnostic devices, study design, participant recruitment, data management and analysis, report writing and dissemination of findings to support the UK’s diagnostic testing and infectious disease surveillance capabilities.
This procurement will allow UKHSA to rapidly initiate evaluation studies in a range of settings including but not limited to primary care, NHS Trusts, organisations, and community.
It is UKHSA’s understanding that this activity is not widely carried out across the Public Sector, so UKHSA therefore wishes to explore the market, identify interest and potential solutions from suitably qualified suppliers and interested parties. The scope of our market engagement may be influenced by the responses we receive.

two.2.14) Additional information

Further information about the Meet the Buyer Event and Request for Information is available via this link
https://atamis-1928.my.salesforce.com/sfc/p/0O000000rwim/a/Sr0000004S5l/9fKXLoULf3Z5CEBPa8vkwJRRzE8XhFdgj__jvCJiaP0
Structure of procurement is yet to be determined this may be influenced by the Request for Information which in turn may influence the contract structure and value.

two.3) Estimated date of publication of contract notice

11 June 2024


Section four. Procedure

four.1) Description

four.1.8) Information about the Government Procurement Agreement (GPA)

The procurement is covered by the Government Procurement Agreement: Yes