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Contract Notice

Manufacture and supply of Pramipexole and matching placebo for clinical trial looking at use in pati

  • First published: 04 May 2018
  • Last modified: 04 May 2018
  • Version: N/A
  • This file may not be fully accessible.

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To record your interest or obtain additional information or documents please find instructions within the Full Notice Text. (NOTE: Contract Award Notices and Prior Information Notices do not normally require a response)

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Contents

Summary

OCID:
Published by:
Northumberland, Tyne and Wear NHS Foundation Trust
Authority ID:
AA33499
Publication date:
04 May 2018
Deadline date:
31 May 2018
Notice type:
Contract Notice
Has documents:
No
Has SPD:
No
Has Carbon Reduction Plan:
N/A

Abstract

Northumberland, Tyne and Wear NHS Foundation Trust (NTW) have successfully bid for a HTA funding to run a National, multi-site, placebo controlled clinical trial looking a pramipexole use in 290 patients with treatment resistant bipolar depression. This will require the manufacture of matching pla...ective disorders service which provides care for patients with complex and/or treatment refractory affective disorders and other treatment refractory conditions complicated by an affective component.

Time Frames.

1 Trial start date: April 2018 (7 months pre-randomisation)

2 Delivery of first batch of IMP – To be advised

3 Delivery of second batch of IMP – To be agreed

4 Study length: 4 years

5 First patient randomisation: November 2018

6 Last patient randomisation: March 2021

Full notice text

Contract notice

Section I: Contracting authority

I.1) Name and addresses

Northumberland, Tyne and Wear NHS Foundation Trust

St Nicholas Hospital, Jubilee Road

Newcastle Upon Tyne

NE3 3XT

UK

Contact person: Mr Gavin Thompson

Telephone: +44 1912232778

E-mail: gavin.thompson@ntw.nhs.uk

NUTS: UKC

Internet address(es)

Main address: http://www.ntw.nhs.uk

Address of the buyer profile: http://www.ntw.nhs.uk

I.3) Communication

The procurement documents are available for unrestricted and full direct access, free of charge at:

https://procontract.due-north.com/Advert/Index?advertId=173d5a00-924c-e811-80eb-005056b64545


Additional information can be obtained from the abovementioned address


Tenders or requests to participate must be sent electronically to:

https://procontract.due-north.com/Advert/Index?advertId=173d5a00-924c-e811-80eb-005056b64545


I.4) Type of the contracting authority

Body governed by public law

I.5) Main activity

Health

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Manufacture and supply of Pramipexole and matching placebo for clinical trial looking at use in patients with treatment resistant bipolar depression.

Reference number: DN337166

II.1.2) Main CPV code

33600000

 

II.1.3) Type of contract

Supplies

II.1.4) Short description

Northumberland, Tyne and Wear NHS Foundation Trust (NTW) have successfully bid for a HTA funding to run a National, multi-site, placebo controlled clinical trial looking a pramipexole use in 290 patients with treatment resistant bipolar depression. This will require the manufacture of matching placebo tablets to pramipexole and the blinding of active pramipexole tablets.

The trial will be run by the Regional Affective Disorders Outpatient Service. This is a specialist / tertiary level affective disorders service which provides care for patients with complex and / or treatment refractory affective disorders and other treatment refractory conditions complicated by an affective component.

For further information and to access tender documents please express interest via the following link: https://procontract.due-north.com/Advert/Index?advertId=173d5a00-924c-e811-80eb-005056b64545.

II.1.6) Information about lots

This contract is divided into lots: No

II.2) Description

II.2.2) Additional CPV code(s)

73000000

II.2.3) Place of performance

NUTS code:

UKC

II.2.4) Description of the procurement

Northumberland, Tyne and Wear NHS Foundation Trust (NTW) have successfully bid for a HTA funding to run a National, multi-site, placebo controlled clinical trial looking a pramipexole use in 290 patients with treatment resistant bipolar depression. This will require the manufacture of matching pla...ective disorders service which provides care for patients with complex and/or treatment refractory affective disorders and other treatment refractory conditions complicated by an affective component.

Time Frames.

1 Trial start date: April 2018 (7 months pre-randomisation)

2 Delivery of first batch of IMP – To be advised

3 Delivery of second batch of IMP – To be agreed

4 Study length: 4 years

5 First patient randomisation: November 2018

6 Last patient randomisation: March 2021

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: Yes

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

Section III: Legal, economic, financial and technical information

III.1) Conditions for participation

III.1.1) Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registers

List and brief description of conditions:

See Tender Documents.

III.2) Conditions related to the contract

Section IV: Procedure

IV.1) Description

IV.1.1) Type of procedure

Open procedure

IV.1.8) Information about Government Procurement Agreement (GPA)

The procurement is covered by the Government Procurement Agreement: Yes

IV.2) Administrative information

IV.2.2) Time limit for receipt of tenders or requests to participate

Date: 31/05/2018

Local time: 12:00

IV.2.4) Languages in which tenders or requests to participate may be submitted

EN

IV.2.7) Conditions for opening of tenders

Date: 31/05/2018

Local time: 13:00

Section VI: Complementary information

VI.1) Information about recurrence

This is a recurrent procurement: No

VI.4) Procedures for review

VI.4.1) Review body

Northumberland Tyne and Wear NHS Foundation Trust

St Nicholas Hospital Jubilee Road Gosforth Newcastle Upon Tyne United Kingdom, NE3 3XT

Newcastle Upon Tyne

NE3 3XT

UK

VI.5) Date of dispatch of this notice

30/04/2018

Coding

Commodity categories

ID Title Parent category
33600000 Pharmaceutical products Medical equipments, pharmaceuticals and personal care products
73000000 Research and development services and related consultancy services Research and Development

Delivery locations

ID Description
100 UK - All

Alert region restrictions

The buyer has restricted the alert for this notice to suppliers based in the following regions.

ID Description
There are no alert restrictions for this notice.

About the buyer

Main contact:
gavin.thompson@ntw.nhs.uk
Admin contact:
N/a
Technical contact:
N/a
Other contact:
N/a

Further information

Date Details
No further information has been uploaded.

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