One-off Contract for Supply of Drug Handling Services in respect of GREAT-2 Clinical Trial (Overlabelling, STorage & Distribution)

Tender description

One-off Contract for the Over Labelling, Storage & Distribution of Research Drugs to Clinical Trial Sites (20 in UK and 10 in Spain) The objective of this procurement is to appoint a single Service Provider for the secondary labelling and packaging into kits of commercially supplied IMP vials and matching placebo vials, and their onward distribution to trial sites, as detailed below: - Importer of Record: act as importer of record to the UK. - IMP to be provided by USA manufacturer and supplied in naked vials which will be individually labelled and packaged; a bivalent, bispecific human immunoglobulin G1 kappa monoclonal antibody - Placebo to be provided by USA manufacturer and supplied in naked vials which will be individually labelled and packaged - Number of participants – Target recruitment is 90 participants - Number of sites and countries: UK: 20-25 sites Spain: 5-10 sites - Labelling: Total number of vials: 1400, shipped in 2 batches Over label packs (IMP and placebo), over labelling to be done at 2-8C Labelling options: Booklet label with two languages (English and Spanish) on each vial/carton