Skip to main content

We've saved some files called cookies on your device. These cookies are:

  • essential for the site to work
  • to help improve our website by collecting and reporting information on how you use it

We would also like to save some cookies to help tailor communications.

BETA
You're viewing an updated version of this service - your feedback will help us to improve it.

Contract Award Notice

Investigational Medicinial Product (IMP) & Placebo Manufacture - IM Woman Trial

  • First published: 22 August 2023
  • Last modified: 22 August 2023
  • Version: N/A
  •  

  • This file may not be fully accessible.

  •  

Information icon

The buyer is not using this website to administer the notice.

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)

Contents

Summary

OCID:
ocds-h6vhtk-02f911
Published by:
London School of Hygiene & Tropical Medicine
Authority ID:
AA21304
Publication date:
22 August 2023
Deadline date:
-
Notice type:
Contract Award Notice
Has documents:
No
Has SPD:
No
Has Carbon Reduction Plan:
N/A

Abstract

Manufacturing and packing of IMP for the IM Woman Trial due to commence in March 2023.

A randomised, triple-blind, three-arm, non-inferiority trial to assess the efficacy and safety of intramuscular tranexamic acid compared to intravenous tranexamic acid and placebo in women having vvaginal and caesarean section births.

Three arms include experimental treatment (IM TXA), reference treatment/active control (IV TXA), and placebo control (0.9% sodium chloride solution).

Treatment Kit Boxes required for 4 campaigns with approximately 10,000 patient packs per campaign. Recruitment period is 24 months - campaign approximately once every 6 months.

Full notice text

Contract award notice

Results of the procurement procedure

Section I: Contracting entity

I.1) Name and addresses

London School of Hygiene & Tropical Medicine

RC000330

Keppel Street,

London

WC1E 7HT

UK

Contact person: Paul Pester

Telephone: +44 02079272471

E-mail: paul.pester@lshtm.ac.uk

NUTS: UKI31

Internet address(es)

Main address: http://www.lshtm.ac.uk

Address of the buyer profile: https://uk.eu-supply.com/ctm/Company/CompanyInformation/Index/104519

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

Investigational Medicinial Product (IMP) & Placebo Manufacture - IM Woman Trial

Reference number: LSHTM-2021-29

II.1.2) Main CPV code

33600000

 

II.1.3) Type of contract

Supplies

II.1.4) Short description

Manufacturing and packing of IMP for the IM Woman Trial due to commence in March 2023.

Three arms include experimental treatment (IM TXA), reference treatment/active control (IV TXA), and placebo control (0.9% sodium chloride solution).

Treatment Kit Boxes required for 4 campaigns with approximately 10,000 patient packs per campaign. Recruitment period is 24 months - campaign approximately once every 6 months.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 1 066 444.00  GBP

II.2) Description

II.2.2) Additional CPV code(s)

33141310

33141320

33621000

33621200

33698000

39299100

44617100

79920000

II.2.3) Place of performance

NUTS code:

UKI31


Main site or place of performance:

LSHTM - Keppel Street, London WC1A 7HT

II.2.4) Description of the procurement

Manufacturing and packing of IMP for the IM Woman Trial due to commence in March 2023.

A randomised, triple-blind, three-arm, non-inferiority trial to assess the efficacy and safety of intramuscular tranexamic acid compared to intravenous tranexamic acid and placebo in women having vvaginal and caesarean section births.

Three arms include experimental treatment (IM TXA), reference treatment/active control (IV TXA), and placebo control (0.9% sodium chloride solution).

Treatment Kit Boxes required for 4 campaigns with approximately 10,000 patient packs per campaign. Recruitment period is 24 months - campaign approximately once every 6 months.

II.2.5) Award criteria

Quality criterion: Technical / Weighting: 70

Price / Weighting:  30

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 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.2.1) Previous publication concerning this procedure

Notice number in the OJ S:

2021/S 000-029090

Section V: Award of contract

Contract No: 1

Title: Investigational Medicinial Product (IMP) & Placebo Manufacture - IM Woman Trial

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

10/08/2023

V.2.2) Information about tenders

Number of tenders received: 1

Number of tenders received by electronic means: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Sharp Clinical Services (UK) Ltd

2234557

Unit 28, Heol Klockner

Rhymney

NP22 5RL

UK

E-mail: Rachel.curran@sharpclinical.com

NUTS: UK

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Total value of the contract/lot: : 1 066 444.00  GBP

V.2.5) Information about subcontracting

Section VI: Complementary information

VI.4) Procedures for review

VI.4.1) Review body

The Royal Courts of Justice

The Strand

London

WC2A 2LL

UK

VI.4.4) Service from which information about the review procedure may be obtained

London School of Hygiene & Tropical Medicine

Keppel Street

London

WC1E 7HT

UK

E-mail: procurement@lshtm.ac.uk

VI.5) Date of dispatch of this notice

21/08/2023

Coding

Commodity categories

ID Title Parent category
33621200 Antihaemorrhagics Medicinal products for the blood and blood-forming organs
44617100 Cartons Boxes
33698000 Clinical products Various medicinal products
39299100 Glass ampoules Glassware
33141320 Medical needles Disposable non-chemical medical consumables and haematological consumables
33621000 Medicinal products for the blood and blood-forming organs Medicinal products for the blood, blood-forming organs and the cardiovascular system
79920000 Packaging and related services Miscellaneous business and business-related services
33600000 Pharmaceutical products Medical equipments, pharmaceuticals and personal care products
33141310 Syringes Disposable non-chemical medical consumables and haematological consumables

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:
paul.pester@lshtm.ac.uk
Admin contact:
N/a
Technical contact:
N/a
Other contact:
N/a

Further information

Date Details
No further information has been uploaded.

0800 222 9004

Lines are open 8:30am to 5pm Monday to Friday.

Rydym yn croesawu galwadau'n Gymraeg.

We welcome calls in Welsh.