Provide Clinical Research Services to Queens University Belfast

Provide Clinical Research Services to Queens University Belfast

The Clinical Trial shall comprise of 180 patients.

United Kingdom-Belfast: Research services

2015/S 188-341268

Contract notice

Services

Directive 2004/18/EC

Section I: Contracting authority

I.1)Name, addresses and contact point(s)

Queens University Belfast
University Road
For the attention of: Mrs Gillian Wasson
BT7 1NN Belfast
UNITED KINGDOM
Telephone: +44 2890973026
E-mail: g.wasson@qub.ac.uk

Internet address(es):

General address of the contracting authority: www.qub.ac.uk/po

Address of the buyer profile: https://in-tendhost.co.uk/queensuniversitybelfast/aspx/Home

Further information can be obtained from: The above mentioned contact point(s)

Specifications and additional documents (including documents for competitive dialogue and a dynamic purchasing system) can be obtained from: The above mentioned contact point(s)

Tenders or requests to participate must be sent to: The above mentioned contact point(s)

I.2)Type of the contracting authority

Body governed by public law

I.3)Main activity

Education

I.4)Contract award on behalf of other contracting authorities

The contracting authority is purchasing on behalf of other contracting authorities: no

Section II: Object of the contract

II.1)Description

II.1.1)Title attributed to the contract by the contracting authority:

QUB/1432/15 Provision of Clinical Research Organisation Services.

II.1.2)Type of contract and location of works, place of delivery or of performance

Services
Service category No 25: Health and social services
Main site or location of works, place of delivery or of performance: The Clinical Trial shall comprise of 180 patients, the location of whom will be randomized, in a number of European countries.
NUTS code FR,GR,SK,UK,MT,CZ,DK,ES,SI,LV,PL,RO,PT,NL,FI,IT,SE,LT,BG,AT,IE,CY,BE,DE,EE,HU,LU

II.1.3)Information about a public contract, a framework agreement or a dynamic purchasing system (DPS)

The notice involves a public contract
II.1.4)Information on framework agreement

II.1.5)Short description of the contract or purchase(s)

Queens University Belfast seeks to appoint a Clinical Research Organisation (CRO) to provide services in respect of managing a Phase II and III Clinical Trial sponsored by Novartis Pharma.

The CRO is required to facilitate a multinational, Phase IIb study in non-Cystic Fibrosis BE patients across Europe. The trial is operating under the Innovative Medicines Initiative (IMI), which is Europe’s largest public-private initiative, aiming to speed up the development of better and safer medicines for patients (http://www.imi.europa.eu/).

II.1.6)Common procurement vocabulary (CPV)

73110000, 85121200, 73111000, 85145000

II.1.7)Information about Government Procurement Agreement (GPA)

The contract is covered by the Government Procurement Agreement (GPA): yes

II.1.8)Lots

This contract is divided into lots: no

II.1.9)Information about variants

Variants will be accepted: no
II.2)Quantity or scope of the contract

II.2.1)Total quantity or scope:

The CRO is required to facilitate a multinational, Phase IIb study in non-Cystic Fibrosis BE patients across Europe.

II.2.2)Information about options

Options: no
II.2.3)Information about renewals

II.3)Duration of the contract or time limit for completion

Starting 4.12.2015.

Section III: Legal, economic, financial and technical information

III.1)Conditions relating to the contract

III.1.1)Deposits and guarantees required:

Applicants seeking to obtain tender documents must first complete and submit a non-disclosure confidentiality agreement. Please note: tender documents will not be issued to any applicant until they have first submitted a completed non-disclosure agreement to Queen’s University Belfast via the electronic tendering system outlined at Section I.1) above.
Non-disclosure agreements may be obtained from the contact details outlined within this notice.
III.1.2)Main financing conditions and payment arrangements and/or reference to the relevant provisions governing them:

III.1.3)Legal form to be taken by the group of economic operators to whom the contract is to be awarded:

Please note: the funding body for this contract does not permit the appointed CRO to further sub-contract services, therefore the CRO must be able to demonstrate their ability to provide the full suite of services outlined in the specification.

III.1.4)Other particular conditions

The performance of the contract is subject to particular conditions: yes
Description of particular conditions: The CRO must be capable of carrying out a randomized clinical trial in all EU Countries. As sub-contracting is not permitted, the appointed CRO must have capability to carry out monitoring in all EU countries in order to be eligible to participate.
III.2)Conditions for participation

III.2.1)Personal situation of economic operators, including requirements relating to enrolment on professional or trade registers

Information and formalities necessary for evaluating if the requirements are met: As outlined within the Procurement Documents.

III.2.2)Economic and financial ability

Information and formalities necessary for evaluating if the requirements are met: As outlined within the Procurement Documents.

III.2.3)Technical capacity

Minimum level(s) of standards possibly required:
The CRO must have demonstrated experience in the management of clinical trials using inhaled compounds in respiratory indications.
The CRO must have the capacity to perform all requested activities including Site Contracting, Site Management, Monitoring, Data Management, Statistics, Medical Writing and Laboratory Analysis (including capacity for sample management of reference laboratory and capacity to interface with other service partners and collaborators).
The CRO must have the resource capacity and associated experience to conduct monitoring in all European Countries.
The CRO must have documented processes in place that are compliant with all applicable laws and regulations, and which describe, at minimum: SOP management, ICH/GCP requirements, quality management system, IT infrastructure, training, organization charts, internal and external audit program, CAPA management, and process for managing regulatory inspections.
III.2.4)Information about reserved contracts
III.3)Conditions specific to services contracts

III.3.1)Information about a particular profession

Execution of the service is reserved to a particular profession: no

III.3.2)Staff responsible for the execution of the service

Legal persons should indicate the names and professional qualifications of the staff responsible for the execution of the service: no

Section IV: Procedure

IV.1)Type of procedure

IV.1.1)Type of procedure

Open
IV.1.2)Limitations on the number of operators who will be invited to tender or to participate
IV.1.3)Reduction of the number of operators during the negotiation or dialogue
IV.2)Award criteria

IV.2.1)Award criteria

The most economically advantageous tender in terms of the criteria stated in the specifications, in the invitation to tender or to negotiate or in the descriptive document

IV.2.2)Information about electronic auction

An electronic auction will be used: no
IV.3)Administrative information

IV.3.1)File reference number attributed by the contracting authority:

QUB/1432/15

IV.3.2)Previous publication(s) concerning the same contract

no

IV.3.3)Conditions for obtaining specifications and additional documents or descriptive document

Time limit for receipt of requests for documents or for accessing documents: 1.11.2015 – 23:59
Payable documents: no

IV.3.4)Time limit for receipt of tenders or requests to participate

2.11.2015 – 16:00
IV.3.5)Date of dispatch of invitations to tender or to participate to selected candidates

IV.3.6)Language(s) in which tenders or requests to participate may be drawn up

English.

IV.3.7)Minimum time frame during which the tenderer must maintain the tender

in days: 120 (from the date stated for receipt of tender)

IV.3.8)Conditions for opening of tenders

Persons authorised to be present at the opening of tenders: no

Section VI: Complementary information

VI.1)Information about recurrence

This is a recurrent procurement: no

VI.2)Information about European Union funds

The contract is related to a project and/or programme financed by European Union funds: no
VI.3)Additional information
VI.4)Procedures for appeal
VI.4.1)Body responsible for appeal procedures

VI.4.2)Lodging of appeals

Precise information on deadline(s) for lodging appeals: This authority will incorporate a standstill period at the point information on the award of the contract is communicated to Tenderers. That notification will provide full information on the award decision. The standstill period, which will be for a minimum of 10 calendar days, provides time for unsuccessful tenderers to challenge the award decision before the contract is entered into.
The Public Contract Regulations 2015 (SI 2015/102) provide for aggrieved parties who have been harmed or are at risk of harm by a breach of the rules to take action in the High Court (England, Wales and Northern Ireland).
VI.4.3)Service from which information about the lodging of appeals may be obtained

VI.5)Date of dispatch of this notice:

24.9.2015

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