Clinical Trial Services Tender

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

Contract notice

Services

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.3)Main activity

Health
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)

85121200

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