II.1)
Scope of the procurement
Investigational Medicinial Product (IMP) & Placebo Manufacture - IM Woman Trial
Reference number:
LSHTM-2021-29
33600000
-
Pharmaceutical products
Supplies
II.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.
II.1.6)
Information about lots
This contract is divided into lots:
no
II.1.7)
Total value of the procurement
Value excluding VAT:
1066444.00
GBP
II.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
II.2.3)
Place of performance
NUTS code:
UKI31 -
Camden and City of London
Main site or place of performance:
LSHTM - Keppel Street, London WC1A 7HT
II.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.
Criteria below
Quality criterion
-
Name:
Technical
/
Weighting:
70
Price
-
Weighting:
30
II.2.11)
Information about options
Options:
no
II.2.13)
Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds:
no