Published date: 27 May 2015
Awarded contract - This means that the contract has been awarded to a supplier.
Contract summary
Industry
Research and development services and related consultancy services - 73000000
Location of contract
East Midlands, West Midlands, East of England, London, Scotland
Value of contract
£47,000 to £57,000
Procurement reference
CON-0061
Published date
27 May 2015
Closing date
30 June 2015
Contract start date
27 July 2015
Contract end date
31 March 2018
Contract type
Not applicable
Procedure type
Other:
Contract is suitable for SMEs?
Yes
Contract is suitable for VCSEs?
No
Description
The Cell Therapy Catapult is managing the conduct of a phase I/II clinical trial to test primarily the acute safety and tolerability, and longer term efficacy, of a cell therapy product in patients with Acute Respiratory Distress Syndrome.
Pharmacovigilance/Safety Management services are required to cover standard clinical trial tasks including: SAE handling/reporting; production of safety management plan, narratives, safety alert letters; single case reporting, periodic/annual reporting, DSMB reporting and conducting safety reviews).
A DSMB will convene on approximately 4 occasions to review interim, unblinded safety data. The primary analysis for safety and efficacy will be performed once the last subject in Cohort 3 completes the Day 28 visit. This is a product that has previously been given to over 200 patients (including UK) in other disease areas.
More information
Attachments
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- Appendix 2 Generic Supplier Quality Questionnaire.docx
- Appendix 2 - Quality Questionnaire
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- CON-0061 - Pharmacovigilance Response Document v1.docx
- ITT Response Document
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- Appendix 1 ARDS Specification_PV.docx
- Appendix 1 - Specification
Additional text
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Bidders wishing to submit a tender are requested to complete the attached response document, including the requested attachments and return them to tenders@ct.catapult.org.uk by the closing date which is 13.00 30th June 2015
Bidders wishing to seek clarifications in relation to the tender or associated documentation may submit queries to tenders@ct.catapult.org.uk. The closing date for tender clarifications is 13.00 on 19th June 2015.
Award information
Awarded date
4 August 2015
Contract start date
16 August 2015
Contract end date
31 March 2018
Total value of contract
£47,000
This contract was awarded to 1 supplier.
Diamond PV
Address
Gemini House
Flex Meadow
Harlow
Essex CM19 5TJReference
None
Supplier is SME?
No
Supplier is VCSE?
No
About the buyer
Address
12th Floor Tower Wing
Guy's Hospital
London
SE1 9RT
England
Website
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Closing: 30 June 2015
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