One -off Contract for the Supply of Drug Handling Services for the trial Sotagliflozin in Patients with Heart Failure Symptoms and Type 1 Diabetes (SOPHIST)

Description

One off Contract for the Over Labelling, Storage & Distribution of Research Drugs to Clinical Trial Sites in the UK. The objective of this procurement is to appoint a single Service Provider for the import, secondary labelling commercially supplied IMP tablets and matching placebo tablets, and their onward distribution to trial sites, as detailed below: -Importer of Record: act as importer of record to the UK. -IMP and placebo to be provided by Patheon (Thermo Fisher Scientific) Canada, on behalf of Lexicon. Both will be supplied in 100ml HDPE containers, induction sealed with Child Resistant Cap. Each container will have 90 tablets, either IMP or placebo, and will be individually labelled and packaged. One container is required per participant for the duration of the trial (i.e. one dispensing of one container to each participant). -IMP is Sotagliflozin 200mg, once daily versus matched placebo. -Number of participants – Target recruitment is 320 participants -Number of sites and countries: UK: 12 sites Overseas: None -Labelling: Total number of containers: Approx 400 containers, shipped into the UK in one or two shipments from manufacturer. Over label containers: (IMP and placebo), over labelling to be done at 15-25oC Labelling options: Single panel label in English on each container. -QP release and distribution: QP release and ship IMP/placebo to up to 12 UK study sites, sites to be confirmed. Two shipments per site: approximately 20 containers (to be confirmed) in the first shipment, second shipment to sites depending on recruitment rates of each site. Distribution to at 15-25oC, with temperature monitor. -Storage 24 months at 15-25oC for active trial period -IMP dossier Appointed Service provider to provide an abbreviated IMP dossier for submission to the MHRA