Clinical Trials Tender

Clinical Trials Tender

Clinical Trials for a new drug product in accordance with ICH Good Clinical Practice. DSTL. UK-Salisbury: medical specialist services

2012/S 111-184693

Contract notice

Services

Directive 2004/18/EC

Section I: Contracting authority

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

DSTL
G02-D, Bldg 5, Porton Down
Contact point(s): B S Morris
SP4 0JQ Salisbury
UNITED KINGDOM
Telephone: +44 1980616067
E-mail: bsmorris@dstl.gov.uk

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

Other: Ministry of Defence (MOD)
I.3)Main activity

Other: Defence
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:

Clinical Trials for a new drug product in accordance with ICH Good Clinical Practice.
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 UKK1

II.1.3)Information about a public contract, a framework agreement or a dynamic purchasing system (DPS)
II.1.4)Information on framework agreement
II.1.5)Short description of the contract or purchase(s)

Medical specialist services.
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

Variants will be accepted: no
II.2)Quantity or scope of the contract
II.2.1)Total quantity or scope:

Dstl has a requirement for Phase 1 Clinical Trials to support the licensures of two drug products. The 1st licensure is a combination of 3 drugs known as the “Triple Therapy”. This new therapy comprises three drug components including a new unlicensed drug and two licensed drugs to be mixed shortly before use and administered intramuscularly by means of an auto injector. The 2nd licensure is for the new unlicensed drug product by intravenous administration. The successful bidder will be required to provide the appropriate volunteers for clinical trials and provide a QP release of the therapy mixture from the pharmacy. The bidder must also hold appropriate MHRA licences to carry out GCP studies.
II.2.2)Information about options
II.2.3)Information about renewals

This contract is subject to renewal: no
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:
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

The performance of the contract is subject to particular conditions: yes
Description of particular conditions: This Contract will be let under Standard MOD Terms and Conditions as appropriate, including applicable DEFCONs/DEFFORMs and bespoke narrative conditions.
III.2)Conditions for participation
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

Information and formalities necessary for evaluating if the requirements are met: (a) Appropriate statements from banks or, where appropriate, evidence of relevant professional risk indemnity insurance.
(b) The presentation of balance-sheets or extracts from the balance-sheets, where publication of the balance-sheet is required under the law of the country in which the economic operator is established.
(c) A statement of the undertaking’s overall turnover and, where appropriate, of turnover in the area covered by the contract for a maximum of the last three financial years available, depending on the date on which the undertaking was set up or the economic operator started trading, as far as the information on these turnovers is available.
III.2.3)Technical capacity

Information and formalities necessary for evaluating if the requirements are met:
(d) A description of the technical facilities and measures used by the supplier or service provider for ensuring quality and the undertaking’s study and research facilities.
(e) Where the products or services to be supplied are complex or, exceptionally, are required for a special purpose, a check carried out by the contracting authorities or on their behalf by a competent official body of the country in which the supplier or service provider is established, subject to that body’s agreement, on the production capacities of the supplier or the technical capacity of the service provider and, if necessary, on the means of study and research which are available to it and the quality control measures it will operate.
(i) A statement of the tools, plant or technical equipment available to the service provider or contractor for carrying out the contract.
(j) An indication of the proportion of the contract which the services provider intends possibly to subcontract.
(k) With regard to the products to be supplied:
(i) samples, descriptions and/or photographs, the authenticity of which must be certified if the contracting authority so requests;
(ii) certificates drawn up by official quality control institutes or agencies of recognised competence attesting the conformity of products clearly identified by references to specifications or standards.
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

Section IV: Procedure

IV.1)Type of procedure
IV.1.1)Type of procedure

Restricted
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:

DSTLX-1000071132
IV.3.2)Previous publication(s) concerning the same contract

Prior information notice

Notice number in the OJEU: 2012/S 68-112068 of 3.4.2012

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

18.7.2012 – 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

The contract is related to a project and/or programme financed by European Union funds: no
VI.3)Additional information

Suppliers interested in working with the Ministry of Defence should register on the MOD Supplier Information Database (SID) Register, available at www.contracts.mod.uk. The MOD SID is a database of active and potential suppliers available to all MOD and UK Defence procurement personnel, and is the main supplier database of MOD Procurement organisations. Please note: the registration and publication of a company profile on the MOD SID does not mean or imply that the supplier has in any way been vetted or approved by the MOD. Suppliers wishing to compete for advertised MOD contracts must respond to any specific call for competition by submitting a separate expression of interest in accordance with the instructions of the purchasing organisation.

Advertising Regime OJEU: This contract opportunity is published in the Official Journal of the European Union (OJEU),the MoD Defence Contracts Bulletin and www.contracts.mod.uk GO Reference: GO-2012611-DCB-3986113.

VI.4)Procedures for appeal
VI.4.1)Body responsible for appeal procedures

DSTL
G02-D, Bldg 5, Porton Down
SP4 0JQ Salisbury
UNITED KINGDOM
E-mail: bsmorris@dstl.gov.uk
Telephone: +44 1980616067

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:11.6.2012