Contract award · 10 Aug 2023

Investigational Medicinial Product (IMP) & Placebo Manufacture - IM Woman Trial

London School of Hygiene & Tropical Medicine awarded “Investigational Medicinial Product (IMP) &…” to Sharp Clinical Services (UK) Ltd for £1.07m.

Medical equipment & pharmaceuticalsLondon

Open competition

Open procedure: the contract was advertised and any supplier could submit a bid.

Key facts

Buyer
London School of Hygiene & Tropical Medicine · Body governed by public law
Value
£1,066,444
Procedure
Open procedure
Sector
Medical equipment & pharmaceuticals · Syringes (CPV 33141310)
Region
London
Timeline
  1. Contract date10 Aug 2023
  2. Published21 Aug 2023Published 11 days after the contract date

Description

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.

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