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Dänemark-Hillerød: Planung und Ausführung von Forschung und Entwicklung
Bekanntmachung vergebener Aufträge
Ergebnisse des Vergabeverfahrens
Abschnitt I: Öffentlicher Auftraggeber
Abschnitt II: Gegenstand
Clinical Trial Support
Clinical trial support regarding delivery of pharmaceuticals i.e. QC, drug accountability, packaging, storage, labelling, and organizing distribution and labeling to multiple centers across Europe.
Rigshospitalet, Copenhagen is principal investigator.
As part of a research project to improve cure rates for children with leukemia we will use a non-marketed, non-EMA (European Medicine Agency) approved liquid formulation of an anticancer agent. The liquid formulation will be produced by a United Kingdom based company. Batches of bottles will be shipped from the company to the supplier for this tender, who will be responsible for:
1) Audit of manufacturing site;
2) Overall quality control;
3) Drug accountability;
4) Review of batch documentation;
5) Packaging and storage until delivery;
6) Labelling (English master text + country-specific labels) of the individual bottles and distribution to the participating European centers as well as organizing the delivery to approximately 900 patients across 100 sites. Anticipated delivery to the individual sites at 1-2 months intervals. However, since individual patients may run out of medication, delivery within 24 hours may occasionally be needed. The study will recruit patients during a 5 years period starting late summer 2020. As patients are on the medication for 1.5 years, the last delivery to the last patient will take place early 2027.
The supplier of the pharmaceutical may obtain EMA marketing approval for the product midway through the study period, in which case no further deliveries are needed and the contract will be terminated.
Abschnitt IV: Verfahren
Urgent for initiation of clinical trial for cancer patients.
Abschnitt V: Auftragsvergabe
Distribution of Pharmaceuticals for a Clinical Trial
Abschnitt VI: Weitere Angaben
Complaints must be filed to Klagenævnet for Udbud no later than 45 days counted from the day after the contract award notice have been published. At the same time as the complaint is filed to Klagenævnet for Udbud it and the reasons (i.e. the rules considered breached) must be delivered to the contracting authority.