Clinical Trial Services Tender
Clinical Trial Services to conduct a prospective multi centre safety post marketing study in patients suffering sever haemophilia A. the study is only expected to take place in Germany but may extend to other countries.
UK-Elstree: medical specialist services
2012/S 127-210757
Directive 2004/18/EC
Section I: Contracting authority
I.1)Name, addresses and contact point(s)
Bio Products Laboratory Limited
Dagger Lane
For the attention of: Leanne Bull
WD6 3BX Elstree
UNITED KINGDOM
Telephone: +44 2089572444
E-mail: leanne.bull@bpl.co.uk
Fax: +44 2089572610
Internet address(es):
General address of the contracting authority: www.bpl.co.uk
Further information can be obtained from: Bio Products Laboratory Limited
Dagger Lane
For the attention of: Rukhsana Shaikh Zaidi
WD6 3BX Elstree
UNITED KINGDOM
Telephone: +44 7711433688
E-mail: rukhsana.shaikhzaidi@bpl.co.uk
Internet address: www.bpl.co.uk
Specifications and additional documents (including documents for competitive dialogue and a dynamic purchasing system) can be obtained from: Bio Products Laboratory Limited
Dagger Lane
For the attention of: Rukhsana Shaikh Zaidi
WD6 3BX Elstree
UNITED KINGDOM
Telephone: +44 7711433688
E-mail: rukhsana.shaikhzaidi@bpl.co.uk
Internet address: www.bpl.co.uk
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.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:
CRO to supply Clnical Trial Services.
II.1.2)Type of contract and location of works, place of delivery or of performance
Services
Service category No 27: Other services
NUTS code UKH23
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)
Clinical Trial Services to conduct a prospective multi centre safety post marketing study in patients suffering sever haemophilia A. the study is only expected to take place in Germany but may extend to other countries.
II.1.6)Common procurement vocabulary (CPV)
II.1.7)Information about Government Procurement Agreement (GPA)
The contract is covered by the Government Procurement Agreement (GPA): no
II.1.8)Lots
This contract is divided into lots: no
II.1.9)Information about variants
II.2)Quantity or scope of the contract
II.2.1)Total quantity or scope:
II.2.2)Information about options
II.2.3)Information about renewals
II.3)Duration of the contract or time limit for completion
Section III: Legal, economic, financial and technical information
III.1)Conditions relating to the contract
III.1.1)Deposits and guarantees required:
III.1.2)Main financing conditions and payment arrangements and/or reference to the relevant provisions governing them:
Payments against agreed milestones.
III.1.3)Legal form to be taken by the group of economic operators to whom the contract is to be awarded:
Limited Company.
III.1.4)Other particular conditions
The performance of the contract is subject to particular conditions: no
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: Year End Accounts.
III.2.2)Economic and financial ability
Information and formalities necessary for evaluating if the requirements are met: References from other clients.
A statement of bidders overall turnover and percentage related to similar activities over the last 3 years.
III.2.3)Technical capacity
Information and formalities necessary for evaluating if the requirements are met:
Evidence of Quality Control System.
Reference of Conformity with external inspection requirements.
Evidence of experience in therapeutic areas.
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: yes
Reference to the relevant law, regulation or administrative provision: Compliance with EU Directives 2001/20/EC and 2005/28/EC ICH-GCP and any country specific regulations concerning the conduct of clinical trials.
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
Accelerated restricted
Justification for the choice of accelerated procedure: To allow BPL to set up Clinical Trials in the timelines required by the licensing authority.
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 below
1. Quakity. Weighting 40
2. Ability to work within timelines. Weighting 35
3. Relevant Expertise. Weighting 25
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:
IV.3.2)Previous publication(s) concerning the same contract
no
IV.3.3)Conditions for obtaining specifications and additional documents or descriptive document
IV.3.4)Time limit for receipt of tenders or requests to participate
17.7.2012 – 17:00
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
IV.3.8)Conditions for opening tenders
Section VI: Complementary information
VI.1)Information about recurrence
This is a recurrent procurement: no
VI.2)Information about European Union funds
VI.3)Additional information
VI.4)Procedures for appeal
VI.4.1)Body responsible for appeal procedures
VI.4.2)Lodging of appeals
VI.4.3)Service from which information about the lodging of appeals may be obtained
VI.5)Date of dispatch of this notice:2.7.2012
