Manufacturing and Packing of Investigational Medicinal Product for IM Woman Trial

About

London School of Hygiene & Tropical Medicine awarded a contract to Sharp Clinical Services (UK) Ltd for the manufacturing and packing of an investigational medicinal product (IMP) for the IM Woman Trial, a randomised, triple-blind, three-arm, non-inferiority trial assessing the efficacy and safety of intramuscular tranexamic acid compared to intravenous tranexamic acid and placebo in women having vaginal and caesarean section births.

The contract covered the provision of treatment kit boxes for four campaigns, with approximately 10,000 patient packs per campaign, over a 24-month recruitment period with campaigns approximately every six months commencing March 2023.

The contract value was £1,066,444.