Investigational Medicinial Product (IMP) - IM Woman Trial

Concepts

• investigational medicinial product
• syringes
• inferiority trial
• im txa
• im woman trial
• imp
• pharmaceutical products
• packing of imp
• medicinal products
• clinical products

Location

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). Provision of 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 commencing March 2023.

CPV Codes

• 33141310 - Syringes
• 33141320 - Medical needles
• 33600000 - Pharmaceutical products
• 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

Indicators

• Contract is suitable for SMEs.

Other Information

Additional data https://uk.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=40736&B=LSHTM User / Company https://uk.eu-supply.com/ctm/Company/CompanyInformation/Index/104519