Section one: Contracting authority
one.1) Name and addresses
London School of Hygiene & Tropical Medicine
Keppel Street,
London
WC1E 7HT
Contact
Paul Pester
Telephone
+44 02079272471
Country
United Kingdom
NUTS code
UKI31 - Camden and City of London
National registration number
RC000330
Internet address(es)
Main address
Buyer's address
https://uk.eu-supply.com/ctm/Company/CompanyInformation/Index/104519
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Investigational Medicinial Product (IMP) & Placebo Manufacture - IM Woman Trial
Reference number
LSHTM-2021-29
two.1.2) Main CPV code
- 33600000 - Pharmaceutical products
two.1.3) Type of contract
Supplies
two.1.4) Short description
Manufacturing and packing of IMP for the IM Woman Trial due to commence in March 2023.
Three arms include experimental treatment (IM TXA), reference treatment/active control (IV TXA), and placebo control (0.9% sodium chloride solution).
Treatment Kit Boxes required for 4 campaigns with approximately 10,000 patient packs per campaign. Recruitment period is 24 months - campaign approximately once every 6 months.
two.1.6) Information about lots
This contract is divided into lots: No
two.1.7) Total value of the procurement (excluding VAT)
Value excluding VAT: £1,066,444
two.2) Description
two.2.2) Additional CPV code(s)
- 33141310 - Syringes
- 33141320 - Medical needles
- 33621000 - Medicinal products for the blood and blood-forming organs
- 33621200 - Antihaemorrhagics
- 33698000 - Clinical products
- 39299100 - Glass ampoules
- 44617100 - Cartons
- 79920000 - Packaging and related services
two.2.3) Place of performance
NUTS codes
- UKI31 - Camden and City of London
Main site or place of performance
LSHTM - Keppel Street, London WC1A 7HT
two.2.4) Description of the procurement
Manufacturing and packing of IMP for the IM Woman Trial due to commence in March 2023.
A randomised, triple-blind, three-arm, non-inferiority trial to assess the efficacy and safety of intramuscular tranexamic acid compared to intravenous tranexamic acid and placebo in women having vvaginal and caesarean section births.
Three arms include experimental treatment (IM TXA), reference treatment/active control (IV TXA), and placebo control (0.9% sodium chloride solution).
Treatment Kit Boxes required for 4 campaigns with approximately 10,000 patient packs per campaign. Recruitment period is 24 months - campaign approximately once every 6 months.
two.2.5) Award criteria
Quality criterion - Name: Technical / Weighting: 70
Price - Weighting: 30
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 four. Procedure
four.1) Description
four.1.1) Type of procedure
Open procedure
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.2.1) Previous publication concerning this procedure
Notice number: 2021/S 000-029090
Section five. Award of contract
Contract No
1
Title
Investigational Medicinial Product (IMP) & Placebo Manufacture - IM Woman Trial
A contract/lot is awarded: Yes
five.2) Award of contract
five.2.1) Date of conclusion of the contract
10 August 2023
five.2.2) Information about tenders
Number of tenders received: 1
Number of tenders received by electronic means: 1
The contract has been awarded to a group of economic operators: No
five.2.3) Name and address of the contractor
Sharp Clinical Services (UK) Ltd
Unit 28, Heol Klockner
Rhymney
NP22 5RL
Rachel.curran@sharpclinical.com
Country
United Kingdom
NUTS code
- UK - United Kingdom
National registration number
2234557
The contractor is an SME
No
five.2.4) Information on value of contract/lot (excluding VAT)
Total value of the contract/lot: £1,066,444
Section six. Complementary information
six.4) Procedures for review
six.4.1) Review body
The Royal Courts of Justice
The Strand
London
WC2A 2LL
Country
United Kingdom
six.4.4) Service from which information about the review procedure may be obtained
London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
Country
United Kingdom