Provide Clinical Research Services to Queens University Belfast
The Clinical Trial shall comprise of 180 patients.
United Kingdom-Belfast: Research services
Section I: Contracting authority
I.1)Name, addresses and contact point(s)
Queens University Belfast
For the attention of: Mrs Gillian Wasson
BT7 1NN Belfast
Telephone: +44 2890973026
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
I.4)Contract award on behalf of other contracting authorities
Section II: Object of the contract
II.1.1)Title attributed to the contract by the contracting authority:
II.1.2)Type of contract and location of works, place of delivery or of performance
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)
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)
II.1.9)Information about variants
II.2.1)Total quantity or scope:
II.2.2)Information about options
II.3)Duration of the contract or time limit for completion
Section III: Legal, economic, financial and technical information
III.1.1)Deposits and guarantees required:
Non-disclosure agreements may be obtained from the contact details outlined within this notice.
III.1.3)Legal form to be taken by the group of economic operators to whom the contract is to be awarded:
III.1.4)Other particular conditions
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.2.1)Personal situation of economic operators, including requirements relating to enrolment on professional or trade registers
III.2.2)Economic and financial ability
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.3.1)Information about a particular profession
III.3.2)Staff responsible for the execution of the service
Section IV: Procedure
IV.1.1)Type of procedure
IV.2.2)Information about electronic auction
IV.3.1)File reference number attributed by the contracting authority:
IV.3.2)Previous publication(s) concerning the same contract
IV.3.3)Conditions for obtaining specifications and additional documents or descriptive document
Payable documents: no
IV.3.4)Time limit for receipt of tenders or requests to participate
IV.3.6)Language(s) in which tenders or requests to participate may be drawn up
IV.3.7)Minimum time frame during which the tenderer must maintain the tender
IV.3.8)Conditions for opening of tenders
Section VI: Complementary information
VI.1)Information about recurrence
VI.2)Information about European Union funds
VI.4.2)Lodging of appeals
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.5)Date of dispatch of this notice: