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End to end CDMO services for the importation, encapsulation and distribution of T3S and Placebo for the LIONNS-D2 Trial

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Summary

Machine-generated summary

Cardiff University has awarded a contract for CDMO services supporting the LIONNS-D2 clinical trial. The services cover importing and QP sign off of T3S and matched placebo tablets made by Ardena in Pamplona, Spain, over encapsulation of commercially secured L-thyroxine and placebo capsules, storage, labelling, and distribution of trial packs to the trial pharmacy at Royal Glamorgan Hospital in Wales. The contract has been awarded. Details of the winning supplier and the contract value are not included in the available facts.

Description

Award notice for the above CDMO services tender. Previous description as follows - The School of Medicine successfully applied for a UKRI grant to investigate in a randomised controlled trial (RCT), a new IMP (investigational medicinal product) called Triiodothyronine sulphate (T3S) in hypothyroid subjects with a gene difference in a thyroid related enzyme called deiodinase 2 (D2). We are looking for a CDMO to (i) Import and QP sign off T3S and matched placebo tablets obtained from Ardena, Pamplona, Spain who will manufacture these to GMP standards; (ii) over encapsulate commercially secured L-thyroxine (LT4 ) and matched placebo capsules; (iii) store T3S and matched placebo obtained from Ardena, and over encapsulated LT4 and matched placebo; (iv) label T3S, LT4 and respective placebo packs for distribution to trial subjects; (v) distribute T3S and matched placebo and over encapsulated LT4 and matched placebo packs to trial pharmacy (Royal Glamorgan Hospital, Wales).

Official source

Source: Find a Tender Service (UK Cabinet Office / Crown Commercial Service)

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Last verified against Find a Tender Service (UK Cabinet Office / Crown Commercial Service) 6 days ago

Documents on Find a Tender Service (UK Cabinet Office / Crown Commercial Service) (English)

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