Monitoring according to GCP (Full revasc)
Karolinska Institutet
Directive 2014/24/EU
Section I: Contracting authority
I.1)
Name and addresses
Karolinska Institutet
202100-2973
Universitetsförvaltningen
Stockholm
171 77
Sweden
Contact person: Krister Karlavagn
E-mail:
krister.karlavagn@ki.se
NUTS code:
SE11
Internet address(es):
Main address: http://www.ki.se
I.2)
Information about joint procurement
I.3)
Communication
Additional information can be obtained from the abovementioned address
I.4)
Type of the contracting authority
Ministry or any other national or federal authority, including their regional or local subdivisions
I.5)
Main activity
Education
Section II: Object
II.1)
Scope of the procurement
II.1.1)
Title:
Monitoring according to GCP (Full revasc)
Reference number: 2-2277/2018
II.1.2)
Main CPV code
79311000
II.1.3)
Type of contract
Services
II.1.4)
Short description:
The Department of Medicine at KI needs a study of Full Revasc.
Invitation to tender.
Karolinska Institutet, hereinafter called KI, invites companies, hereinafter called the Tenderers, to submit tenders concerning service for monitoring and all other aspects of the services of a Clinical Research Organization (CRO) and according to GCP.
Signed agreement is to be used by the Department of Medicine (CMM) at KI.
II.1.5)
Estimated total value
II.1.6)
Information about lots
This contract is divided into lots: no
II.2)
Description
II.2.1)
Title:
II.2.2)
Additional CPV code(s)
79311300
85148000
II.2.3)
Place of performance
NUTS code:
SE11
II.2.4)
Description of the procurement:
Background.
The best strategy for ST-elevation myocardial infarction (STEMI) patients with multi-vessel disease, who undergo primary percutaneous coronary intervention (PCI) of the infarct-related artery (IRA) in the acute phase with remaining multivessel disease, is still not well established. Current guidelines recommend PCI of only the infarct related artery (IRA), and that you should consider PCI of other suspected narrowings. A recent retrospective meta-analysis of 34279 patients with 1819 cardiovascular deaths registered during follow-up showed that PCI of the culprit lesion only is associated with reduced mortality.
However, recent small scale randomised controlled trials indicate that in cases where there is anatomically significant non-culprit multi-vessel disease full revascularization of these non-infarct related arteries during the index procedure is superior to initial conservative treatment. Fractional flow reserve (FFR), a method used to determine ischemia-inducing lesions, has been shown to be superior to angiography-guided PCI in stable angina. Whether performing full revascularization of physiologically significant non-culprit lesions for patients with STEMI improves outcome compared to an initial conservative approach or compared to angiography-guided PCI is not known.
II.2.5)
Award criteria
Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.6)
Estimated value
II.2.7)
Duration of the contract, framework agreement or dynamic purchasing system
Start: 17/07/2018
End: 17/07/2022
This contract is subject to renewal: no
II.2.10)
Information about variants
Variants will be accepted: no
II.2.11)
Information about options
Options: no
II.2.12)
Information about electronic catalogues
II.2.13)
Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)
Additional information
Section III: Legal, economic, financial and technical information
III.1)
Conditions for participation
III.1.1)
Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registers
III.1.2)
Economic and financial standing
III.1.3)
Technical and professional ability
III.1.5)
Information about reserved contracts
III.2)
Conditions related to the contract
III.2.1)
Information about a particular profession
III.2.2)
Contract performance conditions:
III.2.3)
Information about staff responsible for the performance of the contract
Section IV: Procedure
IV.1)
Description
IV.1.1)
Type of procedure
Open procedure
IV.1.3)
Information about a framework agreement or a dynamic purchasing system
IV.1.4)
Information about reduction of the number of solutions or tenders during negotiation or dialogue
IV.1.6)
Information about electronic auction
IV.1.8)
Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: yes
IV.2)
Administrative information
IV.2.1)
Previous publication concerning this procedure
IV.2.2)
Time limit for receipt of tenders or requests to participate
Date: 22/06/2018
Local time: 23:59
IV.2.3)
Estimated date of dispatch of invitations to tender or to participate to selected candidates
IV.2.4)
Languages in which tenders or requests to participate may be submitted:
Swedish
IV.2.6)
Minimum time frame during which the tenderer must maintain the tender
Tender must be valid until: 30/11/2018
IV.2.7)
Conditions for opening of tenders
Date: 25/06/2018
Local time: 00:00
Section VI: Complementary information
VI.1)
Information about recurrence
This is a recurrent procurement: no
VI.2)
Information about electronic workflows
VI.3)
Additional information:
VI.4)
Procedures for review
VI.4.1)
Review body
Förvaltningsrätten
Stockholm
Sweden
VI.4.2)
Body responsible for mediation procedures
VI.4.3)
Review procedure
VI.4.4)
Service from which information about the review procedure may be obtained
VI.5)
Date of dispatch of this notice:
24/05/2018