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

Concepts

• pharmaceutical products
• investigational medicinial product
• im woman trial
• inferiority trial
• im txa
• manufacturing
• placebo control
• imp
• placebo
• packing of imp

Location

LSHTM - Keppel Street, London WC1A 7HT

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.

Total Quantity or Scope

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.

CPV Codes

• 33600000 - Pharmaceutical products
• 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

Indicators

• This is a one-off contract (no recurrence)
• Renewals are not available.
• Professional qualifications are sought.

Other Information

** PREVIEW NOTICE, please check Find a Tender for full details. **