Clinical Evaluation

Description

Delivery of evaluation studies relating to In Vitro Diagnostic devices (IVDs) or pathogen characterisation. Lot 1: 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. <br/>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. <br/>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. <br/>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. Additional information: Further information about the Meet the Buyer Event and Request for Information is available via this link <br/>https://atamis-1928.my.salesforce.com/sfc/p/0O000000rwim/a/Sr0000004S5l/9fKXLoULf3Z5CEBPa8vkwJRRzE8XhFdgj__jvCJiaP0<br/>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.