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.
Deadline
Fristen for modtagelse af bud var på 2019-05-27.
Indkøbet blev offentliggjort på 2019-05-06.
Leverandører
Følgende leverandører er nævnt i tildelingsbeslutninger eller andre indkøbsdokumenter:
Objekt Omfanget af udbuddet
Titel: Clinical Trial Support
19027986
Produkter/tjenester: Planlægning og udførelse af forskning og udvikling📦
Kort beskrivelse:
“Clinical trial support regarding delivery of pharmaceuticals i.e. QC, drug accountability, packaging, storage, labelling, and organizing distribution and...”
Kort beskrivelse
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.
1️⃣
Sted for udførelsen: Sverige 🏙️
Sted for udførelsen: Portugal 🏙️
Sted for udførelsen: Norge 🏙️
Sted for udførelsen: Nederland 🏙️
Sted for udførelsen: Lietuva 🏙️
Sted for udførelsen: Italia 🏙️
Sted for udførelsen: Ísland 🏙️
Sted for udførelsen: Éire/Ireland 🏙️
Sted for udførelsen: France 🏙️
Sted for udførelsen: Suomi/Finland 🏙️
Sted for udførelsen: Eesti 🏙️
Sted for udførelsen: Danmark🏙️
Sted for udførelsen: Deutschland 🏙️
Sted for udførelsen: Belgique/België 🏙️
Hovedsted eller sted for udførelsen: Rigshospitalet, Copenhagen is principal investigator.
Beskrivelse af udbuddet:
“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...”
Beskrivelse af udbuddet
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.
Vis mere Kriterier for tildeling
Prisen er ikke det eneste tildelingskriterium, og alle kriterier er kun anført i udbudsdokumenterne
Omfanget af udbuddet
Anslået samlet værdi ekskl. moms: DKK 3 000 000 💰
Varighed
Startdato: 2019-08-01 📅
Slutdato: 2027-06-30 📅
Beskrivelse
Yderligere oplysninger:
“The supplier of the pharmaceutical may obtain EMA marketing approval for the product midway through the study period, in which case no further deliveries...”
Yderligere oplysninger
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.
Juridiske, økonomiske, finansielle og tekniske oplysninger Teknisk og faglig kompetence
Liste og kortfattet beskrivelse af udvælgelseskriterier:
“Experience with projects of similar scope and size (no patients, sites, countries).” Betingelser for deltagelse
Betingelser for deltagelse (tekniske og faglige kvalifikationer):
“At least 5 projects of at least 1 year duration during the last 3 years must be presented as references; the references must include 2 or more cancer...”
Betingelser for deltagelse (tekniske og faglige kvalifikationer)
At least 5 projects of at least 1 year duration during the last 3 years must be presented as references; the references must include 2 or more cancer projects. Each project elegible for reference must involve several sites in different European countries and at least 100 pt. each. Short description of project and scope, duration/time (start to finish), no patients, no of sites, involved countries, and therapeutic area must be stated in the tender for each reference. Only projects conducted under European regulations will be considered.
Vis mere Betingelser i forbindelse med kontrakten
Betingelser for opfyldelse af kontrakten:
“The supplier must expect to accept a data processing agreement with the Contraction Authority.”
Procedure Type af procedure
Åben procedure
Fremskyndet procedure: Urgent for initiation of clinical trial for cancer patients.
Administrative oplysninger
Frist for modtagelse af bud eller ansøgninger om deltagelse: 2019-05-27
12:00 📅
Sprog, på hvilke bud eller ansøgninger om deltagelse kan indgives: engelsk 🗣️
Buddet skal være gyldigt indtil: 2019-08-27 📅
Betingelser for åbning af buddene: 2019-05-27
12:00 📅
Supplerende oplysninger Gennemgå organ
Navn: Klagenævnet for Udbud
Postadresse: Nævnenes Hus, Toldboden 2
Postby: Viborg
Postnummer: 8800
Land: Danmark 🇩🇰
Telefon: +45 72405600📞
E-mail: klfu@naevneneshus.dk📧
URL: http://www.klfu.dk🌏 Gennemgangsprocedure
Præcise oplysninger om fristerne for gennemgangsprocedurer:
“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...”
Præcise oplysninger om fristerne for gennemgangsprocedurer
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.
Vis mere Tjeneste, hvorfra der kan indhentes oplysninger om klageproceduren
Navn: Konkurrence- og forbrugerstyrelsen
Postadresse: Carl Jacobsens Vej 35
Postby: Valby
Postnummer: 2500
Land: Danmark 🇩🇰
Telefon: +45 41715000📞
E-mail: kfst@kfst.dk📧
URL: http://www.kfst.dk🌏
Kilde: OJS 2019/S 089-213409 (2019-05-06)
Bekendtgørelse om indgåede kontrakter (2021-02-18) Objekt Kriterier for tildeling
Pris
Procedure Administrative oplysninger
Tidligere offentliggørelse vedrørende denne procedure: 2019/S 089-213409
Tildeling af kontrakt
1️⃣
Kontraktnummer: 1
Titel: Distribution of Pharmaceuticals for a Clinical Trial
Oplysninger om ikke-tilskudsgivende
Der blev ikke modtaget nogen bud eller ansøgninger om deltagelse, eller alle blev afvist
Supplerende oplysninger Gennemgangsprocedure
Præcise oplysninger om fristerne for gennemgangsprocedurer:
“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...”
Præcise oplysninger om fristerne for gennemgangsprocedurer
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.
Vis mere
Kilde: OJS 2021/S 037-093043 (2021-02-18)
Bekendtgørelse om indgåede kontrakter (2021-02-18) Ordregivende myndighed Navn og adresser
Telefon: +45 60941215📞
URL: http://www.regionh.dk🌏
Objekt Omfanget af udbuddet
Samlet værdi af indkøbsaftalen (ekskl. moms): EUR 4 500 000 💰
Procedure Type af procedure
Ingen bud eller ingen egnede bud/ansøgninger om deltagelse som svar på den åbne procedure
Tildeling af en kontrakt uden forudgående offentliggørelse af en indkaldelse af bud i Den Europæiske Unions Tidende (begrundelse): No tenders were received in the open procedure.
Tildeling af kontrakt
Kontraktnummer: 4700006742
Titel: Clinical Trial Support
Dato for indgåelse af kontrakten: 2020-12-15 📅
Oplysninger om udbud
Antal modtagne bud: 1
Navn og adresse på kontrahenten
Navn: Klifo A/S
Postby: Glostrup
Land: Danmark 🇩🇰
Region: Københavns omegn🏙️
Entreprenøren er en SMV
Oplysninger om kontraktens/parcellens værdi (ekskl. moms)
Kontraktens/parcellens samlede værdi: DKK 4 500 000 💰