H/2813 - Purchase, Importation, Storage, QP certification, Distribution and Labelling of Drug for Clinical Trial

Tender description

The Clinical Trial Research Unit at the University of Leeds is seeking tenders for the Purchase, importation, distribution, storage, labelling and QP release of a drug for a clinical trial. The Clinical Trial is called ReoGlio and it is looking at a new treatment combination in adult patients with glioblastoma multiforme. The two medicinal products to be used in combination are the reovirus (REOLYSIN®) and GM-CSF which will be given alongside the standard of care chemoradiotherapy (6 weeks) and adjuvant chemotherapy (6 months). The study will look at the safety and tolerability of this combination. We will recruit up to 24 participants and we hope to open to recruitment by May 2017. We are looking for a company to procure, import, label, store & distribute a drug to the four hospitals we will have in a clinical trial (3 in England and 1 in Scotland). The addresses of each site are included as appendix 9 The storage is planned to be 18 months however this may need to be extended depending on the recruitment rate of participants. The expected start date is May 2017. There will be distribution to the four sites, approximately 1 shipment every 4-6 months per site. However this may vary depending on recruitment rates. Depending on the expiry dates of the drug, more than one shipment of drug may be required to be processed during the trial.