1. The subject of the contract is: a placebo manufacturing service for the clinical trial and a product management service for the trial including documentation, labelling, repackaging and release for use in the clinical trial; storage and inventory of the test products, release from storage, transport to clinical centres and disposal for the project “A randomised, double-blind, three parallel-group, placebo controlled superiority trial assessing the effect of intrcrvenous versus oral iron supplementation on physical performance in iron deficient FRAIL elderly IndiviDuals with cardiovascular disease (FRAIL-IDtrial)”. 2. Brief description of the subject of the contract: The subject of the contract is a service comprising the following tasks: a) Task 1. Development of IMPD for placebo tablets (placebo of Tardiferon or equivalent) and development of label designs, (b) Task 2. Production of a placebo of Tardiferon or equivalent, c) Task 3. Taking into account: - acceptance of delivery, appropriate labelling, relabelling and release of the product for the clinical trial - ampoules containing sodium chloride 0.9% (NaCl) in a volume of 10 ml in a quantity of 2138 units, which will constitute an intravenous placebo, - acceptance of delivery, repackaging, appropriate labelling, relabelling and release of the product for the clinical trial - including transfer of Tardiferon tablets or equivalent (Ferrous sulfate, 80 mg) in a quantity of 54 000 units to new unit bottles, - acceptance of delivery, appropriate labelling, relabelling and release of the product for the clinical trial - Ferinject or equivalent (500 mg carboxymaltose, 10 ml) in a quantity of 830 units, - acceptance of delivery of sodium chloride 0.9% (NaCl) in a volume of 100 ml, necessary for the preparation of solutions for intravenous administration (placebo and the test product) - in a quantity of 1250 units, d) Task 4. Transport to the centres indicated by the Ordering Party and logistics management (including documentation) of products, e) Task 5. Storage of all products, f) Task 6. Disposal of unused or expired products tested after the end of the project. 3. The Ordering Party informs that in the case of providing the Contractor with medicines equivalent to those described above, i.e. Tardiferon and Ferinject, equivalent drugs will meet the following requirements: 1. contain the same active substance in the same dose and form of release, without the addition of other active substances; 2) the pharmaceutical form (e.g. film-coated tablet, solution for injection) will be identical or functionally equivalent – i.e. providing the same absorption and pharmacological parameters; 3) the route of administration will be the same (e.g. oral, intravenous); 4) the product will be registered as a medicinal product authorised on the territory of Poland by URPL or authorised under the Union procedure; 5) it will not be preparations with the status of: a food supplement, a foodstuff intended for particular nutritional uses, a medical device or a prescription drug. 3. The subject-matter of the contract is described in detail in the description of the subject-matter of the contract (Annex 2 to the FTZ) and in the detailed cost estimate (Annex 3 to the FTZ). Detailed conditions and rules for the implementation of the contract are set out in the Model Contract (Annex 4 to the FTZ).
Text automatically translated in your browsing language
Automatically translated
