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Ireland-Galway: Research services

Ireland-Galway: Research services has been closed on 15 Nov 2021. It no longer accepts any bids. For further information, you can contact the National University of Ireland, Galway (NUI Galway) (N/A)

Bellow, you can find more information about this project: 

Location: Ireland

General information

Donor:

National University of Ireland, Galway (NUI Galway) (N/A)

Industry:

Business Services

Status:

Closed

Timeline

Published:

19 Nov 2021

Deadline:

15 Nov 2021

Value:

2800000

Contacts

Name:

Máire Hornibrook

Phone:

+353 91524411

+353 868598777

+1 2064467949

Email: [email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]

Description

Contract award notice

Results of the procurement procedure

Services

Legal Basis:
Directive 2014/24/EU

Section I: Contracting authority

I.1)Name and addresses
Official name: National University of Ireland, Galway (NUI Galway)
National registration number: N/A
Postal address: University Road
Town: Galway
NUTS code: IE042 West
Postal code: Galway
Country: Ireland
Contact person: Máire Hornibrook
E-mail: [email protected]
Telephone: +353 91524411
Internet address(es):
Main address: http://www.nuigalway.ie
Address of the buyer profile: https://irl.eu-supply.com/ctm/Company/CompanyInformation/Index/414
I.4)Type of the contracting authority
Body governed by public law
I.5)Main activity
Education

Section II: Object

II.1)Scope of the procurement
II.1.1)Title:

Clinical Research Services in 10 Lots

Reference number: NUIG/CON1218/2020
II.1.2)Main CPV code
73110000 Research services
II.1.3)Type of contract
Services
II.1.4)Short description:

This is a Contract Award Notice.

Lot 1A: Clinical Research Full Service - Device Trials (Full Service including financial invoicing)

Lot 1B: Clinical Research Full Service - Pharma Trials (Full Service including financial invoicing)

Lot 2: Clinical Research Services: Quality and Regulatory services for Clinical Trials

Lot 3: Clinical Research Services: Biostatistics and Clinical Study Design services for Clinical Trials

Lot 4: Clinical Research Services: Study Co-ordination & Management services for Clinical Trials

Lot 5A : Clinical Research Safety Services - Clinical Trial Device vigilance/safety services

Lot 5B : Clinical Research Safety Services - Clinical Trial Pharmacovigilance/safety services

Lot 6: Clinical Research Services: Clinical Database programming and data management services

Lot 7: Clinical Research Services: Validation and Compliance services for clinical trials

Lot 8: Clinical Research Services: Medical writing and Translation services

II.1.6)Information about lots
This contract is divided into lots: yes
II.1.7)Total value of the procurement (excluding VAT)
Value excluding VAT: 2 800 000.00 EUR
II.2)Description
II.2.1)Title:

Lot 1A: Clinical Research Full Service - Device Trials (Full Service including financial invoicing)

Lot No: 1A
II.2.2)Additional CPV code(s)
73000000 Research and development services and related consultancy services
73100000 Research and experimental development services
73111000 Research laboratory services
73200000 Research and development consultancy services
73210000 Research consultancy services
79530000 Translation services
II.2.3)Place of performance
NUTS code: IE042 West
II.2.4)Description of the procurement:

The services of a full-service Clinical Research Organisation are required to provide clinical research support services as required to support scaling the internal expertise and internal team activity as required with the Research centre undertaking clinical trial research. The service provider will have with a speciality in managing device clinical trials and post-market device clinical follow-up studies from study set up phase through to close out. Full service includes all aspects and services required with the full service execution for the trial lifecycle (project management, coordination, site management, programming and data management, safety management, statistical support, compliance, quality and regulatory support, medical writing and translation, and financial invoicing support if applicable).

II.2.5)Award criteria
Quality criterion - Name: Understanding of Brief and Proposed Methodology / Weighting: 50
Quality criterion - Name: Quality of Team Proposed / Weighting: 30
Price - Weighting: 20
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
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Lot 1B: Clinical Research Full Service - Pharma Trials (Full Service including financial invoicing)

Lot No: 1B
II.2.2)Additional CPV code(s)
73000000 Research and development services and related consultancy services
73100000 Research and experimental development services
73111000 Research laboratory services
73200000 Research and development consultancy services
73210000 Research consultancy services
79530000 Translation services
II.2.3)Place of performance
NUTS code: IE042 West
II.2.4)Description of the procurement:

The services of a full-service Clinical Research Organisation are required to provide clinical research support services as required to support scaling the internal expertise and internal team activity as required with the Research centre undertaking clinical trial research. The service provider will have with a speciality in managing IMP/ATMP clinical trials and post-market clinical follow-up studies from study set up phase through to close out. Full service includes all aspects and services required with the full service execution for the trial lifecycle (project management, coordination, site management, programming and data management, safety management, statistical support, compliance, quality and regulatory support, medical writing and translation, and financial invoicing support if applicable).

II.2.5)Award criteria
Quality criterion - Name: Understanding of Brief and Proposed Methodology / Weighting: 50
Quality criterion - Name: Quality of Team Proposed / Weighting: 30
Price - Weighting: 20
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
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Lot 2: Clinical Research Services: Quality and Regulatory services for Clinical Trials

Lot No: 2
II.2.2)Additional CPV code(s)
73000000 Research and development services and related consultancy services
73100000 Research and experimental development services
73111000 Research laboratory services
73200000 Research and development consultancy services
73210000 Research consultancy services
79530000 Translation services
II.2.3)Place of performance
NUTS code: IE042 West
II.2.4)Description of the procurement:

Quality and regulatory operational support may be required on occasion as a support/scale up requirement to support internal quality and regulatory resources in the delivery of clinical research trials with a view to providing and delivering on quality assurance measures as required by the sponsor and coordination centres’ programme.

Includes service support for audits and inspections-audit readiness activities and remediation support including CAPA support.

Regulatory gap analysis and quality system update support as required by applicable regulations and standard updates.

II.2.5)Award criteria
Quality criterion - Name: Understanding of Brief and Proposed Methodology / Weighting: 50
Quality criterion - Name: Quality of Team Proposed / Weighting: 30
Price - Weighting: 20
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
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Lot 3: Clinical Research Services: Biostatistics and Clinical Study Design services for Clinical Tri

Lot No: 3
II.2.2)Additional CPV code(s)
73000000 Research and development services and related consultancy services
73100000 Research and experimental development services
73111000 Research laboratory services
73200000 Research and development consultancy services
73210000 Research consultancy services
79530000 Translation services
II.2.3)Place of performance
NUTS code: IE042 West
II.2.4)Description of the procurement:

Operational and strategic biostatistical support for Clinical research activities. Including Protocol design support and statistical analysis plan support for clinical research trials working closely with academic team and coordination team including data management.

Maintenance of statistical database for the clinical studies, drafting and updating relevant statistical standard operating procedures.

Statistical support/advices for the academic/scientific projects of the academic team (e.g. supporting statistical analysis of various imaging analysis).

Working with investigators and the research centre to develop and disseminate statistical methods and techniques that add to the intellectual understanding of the field and the wider scientific and clinical community.

Support the preparation of peer review manuscripts for publication and/or research bids and provide expert advice on research issues to the research team.

II.2.5)Award criteria
Quality criterion - Name: Understanding of Brief and Proposed Methodology / Weighting: 50
Quality criterion - Name: Quality of Team Proposed / Weighting: 30
Price - Weighting: 20
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
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Lot 4: Clinical Research Services: Study Co-ordination & Management services for Clinical Trials

Lot No: 4
II.2.2)Additional CPV code(s)
73000000 Research and development services and related consultancy services
73100000 Research and experimental development services
73111000 Research laboratory services
73200000 Research and development consultancy services
73210000 Research consultancy services
79530000 Translation services
II.2.3)Place of performance
NUTS code: IE042 West
II.2.4)Description of the procurement:

Work alongside the research centre during trial set up, execution and close out as required to delivery clinical research study coordination and project management services including but not limited to coordination of study documentation during set up, regulatory and ethic approval management, site feasibility and selection processes, site contracting process, site initiations and site training, site management, study management and all associated services during execution phase and study close out phase.

II.2.5)Award criteria
Quality criterion - Name: Understanding of Brief and Proposed Methodology / Weighting: 50
Quality criterion - Name: Quality of Team Proposed / Weighting: 30
Price - Weighting: 20
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
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Lot 5A : Clinical Research Safety Services - Clinical Trial Device vigilance/safety services

Lot No: 5A
II.2.2)Additional CPV code(s)
73000000 Research and development services and related consultancy services
73100000 Research and experimental development services
73111000 Research laboratory services
73200000 Research and development consultancy services
73210000 Research consultancy services
79530000 Translation services
II.2.3)Place of performance
NUTS code: IE042 West
II.2.4)Description of the procurement:

Work alongside the research centre during trial set up, execution and close out as required to delivery clinical research device vigilance and safety management services including but not limited to coordination of all study safety documentation during set up including safety database, safety management and processing for all study related safety events during study execution including regulatory and ethics reporting as required, management of clinical event adjudication process and any other safety management related services during execution phase and study close out phase.

II.2.5)Award criteria
Quality criterion - Name: Understanding of Brief and Proposed Methodology / Weighting: 50
Quality criterion - Name: Quality of Team Proposed / Weighting: 30
Price - Weighting: 20
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
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Lot 5B : Clinical Research Safety Services - Clinical Trial Pharmacovigilance/safety services

Lot No: 5B
II.2.2)Additional CPV code(s)
73000000 Research and development services and related consultancy services
73100000 Research and experimental development services
73111000 Research laboratory services
73200000 Research and development consultancy services
73210000 Research consultancy services
79530000 Translation services
II.2.3)Place of performance
NUTS code: IE042 West
II.2.4)Description of the procurement:

Work alongside the research centre during trial set up, execution and close out as required to delivery clinical research pharmacovigilance and safety management services including but not limited to coordination of all study safety documentation during set up including safety database, safety management and processing for all study related safety events during study execution including regulatory and ethics reporting as required, management of clinical event adjudication process and any other safety management related services during execution phase and study close out phase.

II.2.5)Award criteria
Quality criterion - Name: Understanding of Brief and Proposed Methodology / Weighting: 50
Quality criterion - Name: Quality of Team Proposed / Weighting: 30
Price - Weighting: 20
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
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Lot 6: Clinical Research Services: Clinical Database programming and data management services

Lot No: 6
II.2.2)Additional CPV code(s)
73000000 Research and development services and related consultancy services
73100000 Research and experimental development services
73111000 Research laboratory services
73200000 Research and development consultancy services
73210000 Research consultancy services
79530000 Translation services
II.2.3)Place of performance
NUTS code: IE042 West
II.2.4)Description of the procurement:

Work alongside the research centre during trial set up, execution and close out as required to delivery clinical research database development, database administration and data management services including but not limited to coordination of all data management related documentation during set up including study database set up activities, database testing and validation tasks for eCRF finalization, data management and processing for all study data during study execution and any other data management related services during execution phase and study close out phase.

II.2.5)Award criteria
Quality criterion - Name: Understanding of Brief and Proposed Methodology / Weighting: 50
Quality criterion - Name: Quality of Team Proposed / Weighting: 30
Price - Weighting: 20
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
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Lot 7: Clinical Research Services: Validation and Compliance services for clinical trials

Lot No: 7
II.2.2)Additional CPV code(s)
73000000 Research and development services and related consultancy services
73100000 Research and experimental development services
73111000 Research laboratory services
73200000 Research and development consultancy services
73210000 Research consultancy services
79530000 Translation services
II.2.3)Place of performance
NUTS code: IE042 West
II.2.4)Description of the procurement:

Work with the Research Centre to ensure that all clinical research associated computerised systems and associated clinical research software packages are introduced, maintained and operating in accordance with GCP, GAMP 5 requirements, Lab Policies and Procedures and regulatory requirements with a keen focus on Data Integrity.

Work with the team on the introduction of new software including validation impact assessment under change control processes and any required validation activities including preparation of validation related documentation, standard operating procedures, reports, test scripts and change controls with regards to computer systems validation.

Support for audit readiness and audit compliance activities with regard to computer system compliance as required per GAMP 5 and any applicable regulatory requirements.

II.2.5)Award criteria
Quality criterion - Name: Understanding of Brief and Proposed Methodology / Weighting: 50
Quality criterion - Name: Quality of Team Proposed / Weighting: 30
Price - Weighting: 20
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
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Lot 8: Clinical Research Services: Medical writing and Translation services

Lot No: 8
II.2.2)Additional CPV code(s)
79530000 Translation services
II.2.3)Place of performance
NUTS code: IE042 West
II.2.4)Description of the procurement:

Support the certified translation of Medical and legal documentation associated with the delivery of the clinical research programme ongoing with the Research centre.

Documentation includes clinical trial contracts, patient information and informed consent forms, study protocol etc.

II.2.5)Award criteria
Quality criterion - Name: Understanding of Brief and Proposed Methdology / Weighting: 50
Quality criterion - Name: Quality of Team Proposed / Weighting: 30
Price - Weighting: 20
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
II.2.14)Additional information

Section IV: Procedure

IV.1)Description
IV.1.1)Type of procedure
Open procedure
IV.1.3)Information about a framework agreement or a dynamic purchasing system
The procurement involves the establishment of a framework agreement
IV.1.8)Information about the 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 063-160281
IV.2.8)Information about termination of dynamic purchasing system
IV.2.9)Information about termination of call for competition in the form of a prior information notice

Section V: Award of contract

Contract No: 1
Lot No: 1
Title:

Lot 1A: Clinical Research Full Service - Device Trials (Full Service including financial invoicing)

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: Afortiori Development
National registration number: E3430005NH
Postal address: Portershed
Town: Galway
NUTS code: IE042 West
Postal code: Galway
Country: Ireland
E-mail: [email protected]
Internet address: http://www.aftdev.com
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 200 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 2
Lot No: 1
Title:

Lot 1A: Clinical Research Full Service - Device Trials (Full Service including financial invoicing)

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: MCRA LLC
National registration number: 861097944
Postal address: 1050 K St NW
Town: Washington
NUTS code: US United States
Postal code: Suite 10
Country: United States
E-mail: [email protected]
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 200 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 3
Lot No: 1
Title:

Lot 1A: Clinical Research Full Service - Device Trials (Full Service including financial invoicing)

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: TRIUM Clinical Consulting NV
National registration number: BE0837988839
Postal address: Baron Opsomerlaan 32
Town: LIER
NUTS code: BE Belgique / België
Postal code: 2500
Country: Belgium
E-mail: [email protected]
Internet address: http://www.triumclinicalconsulting.com
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 200 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 4
Lot No: 2
Title:

Lot 1B: Clinical Research Full Service - Pharma Trials (Full Service including financial invoicing)

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: Afortiori Development
National registration number: E3430005NH
Postal address: Portershed
Town: Galway
NUTS code: IE042 West
Postal code: Galway
Country: Ireland
E-mail: [email protected]
Internet address: http://www.aftdev.com
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 200 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 5
Lot No: 2
Title:

Lot 1B: Clinical Research Full Service - Pharma Trials (Full Service including financial invoicing)

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: TRIUM Clinical Consulting NV
National registration number: BE0837988839
Postal address: Baron Opsomerlaan 32
Town: LIER
NUTS code: BE Belgique / België
Postal code: 2500
Country: Belgium
E-mail: [email protected]
Internet address: http://www.triumclinicalconsulting.com
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 200 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 6
Lot No: 3
Title:

Lot 2: Clinical Research Services: Quality and Regulatory services for Clinical Trials

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: Common Sense Clinical
National registration number: NL001882722B20
Postal address: Nieuw-Loosdrechtsedijk140
Town: Loosdrecht
NUTS code: NL Nederland
Postal code: 1231LC
Country: Netherlands
E-mail: [email protected]
Internet address: http://www.commonsenseclinical.nl
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 7
Lot No: 3
Title:

Lot 2: Clinical Research Services: Quality and Regulatory services for Clinical Trials

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: MCRA LLC
National registration number: 861097944
Postal address: 1050 K St NW
Town: Washington
NUTS code: US United States
Postal code: Suite 10
Country: United States
E-mail: [email protected]
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 8
Lot No: 3
Title:

Lot 2: Clinical Research Services: Quality and Regulatory services for Clinical Trials

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: TRIUM Clinical Consulting NV
National registration number: BE0837988839
Postal address: Baron Opsomerlaan 32
Town: LIER
NUTS code: BE Belgique / België
Postal code: 2500
Country: Belgium
E-mail: [email protected]
Internet address: http://www.triumclinicalconsulting.com
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 9
Lot No: 4
Title:

Lot 3: Clinical Research Services: Biostatistics and Clinical Study Design services for Clinical Tri

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: Afortiori Development
National registration number: E3430005NH
Postal address: Portershed
Town: Galway
NUTS code: IE042 West
Postal code: Galway
Country: Ireland
E-mail: [email protected]
Internet address: http://www.aftdev.com
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 10
Lot No: 4
Title:

Lot 3: Clinical Research Services: Biostatistics and Clinical Study Design services for Clinical Tri

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: DF/Net Research, Inc.
National registration number: 200852149
Postal address: 140 Lakeside Ave., Suite 310
Town: Seattle
NUTS code: US United States
Postal code: 98122
Country: United States
E-mail: [email protected]
Telephone: +1 2064467949
Internet address: http://www.dfnetresearch.com
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 11
Lot No: 4
Title:

Lot 3: Clinical Research Services: Biostatistics and Clinical Study Design services for Clinical Tri

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: MCRA LLC
National registration number: 861097944
Postal address: 1050 K St NW
Town: Washington
NUTS code: US United States
Postal code: Suite 10
Country: United States
E-mail: [email protected]
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 12
Lot No: 4
Title:

Lot 3: Clinical Research Services: Biostatistics and Clinical Study Design services for Clinical Tri

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: StatisticaMedica Ltd
National registration number: 9670232P
Postal address: 26 Belarmine Court
Town: Stepaside
NUTS code: IE061 Dublin
Postal code: D18 TD82
Country: Ireland
E-mail: [email protected]
Telephone: +353 868598777
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 13
Lot No: 4
Title:

Lot 3: Clinical Research Services: Biostatistics and Clinical Study Design services for Clinical Tri

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: TRIUM Clinical Consulting NV
National registration number: BE0837988839
Postal address: Baron Opsomerlaan 32
Town: LIER
NUTS code: BE Belgique / België
Postal code: 2500
Country: Belgium
E-mail: [email protected]
Internet address: http://www.triumclinicalconsulting.com
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 14
Lot No: 5
Title:

Lot 4: Clinical Research Services: Study Co-ordination & Management services for Clinical Trials

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: Afortiori Development
National registration number: E3430005NH
Postal address: Portershed
Town: Galway
NUTS code: IE042 West
Postal code: Galway
Country: Ireland
E-mail: [email protected]
Internet address: http://www.aftdev.com
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 15
Lot No: 5
Title:

Lot 4: Clinical Research Services: Study Co-ordination & Management services for Clinical Trials

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: Common Sense Clinical
National registration number: NL001882722B20
Postal address: Nieuw-Loosdrechtsedijk140
Town: Loosdrecht
NUTS code: NL Nederland
Postal code: 1231LC
Country: Netherlands
E-mail: [email protected]
Internet address: http://www.commonsenseclinical.nl
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 16
Lot No: 5
Title:

Lot 4: Clinical Research Services: Study Co-ordination & Management services for Clinical Trials

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: MCRA LLC
National registration number: 861097944
Postal address: 1050 K St NW
Town: Washington
NUTS code: US United States
Postal code: Suite 10
Country: United States
E-mail: [email protected]
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 17
Lot No: 5
Title:

Lot 4: Clinical Research Services: Study Co-ordination & Management services for Clinical Trials

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: Rede Optimus Hospitalar AG
National registration number: CHE-216.455.548 MWST
Postal address: Fröbelstrasse 10
Town: Zürich
NUTS code: CH Schweiz / Suisse / Svizzera
Postal code: 8032
Country: Switzerland
E-mail: [email protected]
Internet address: http://www.rdeoptimus.com.br
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 18
Lot No: 5
Title:

Lot 4: Clinical Research Services: Study Co-ordination & Management services for Clinical Trials

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: TRIUM Clinical Consulting NV
National registration number: BE0837988839
Postal address: Baron Opsomerlaan 32
Town: LIER
NUTS code: BE Belgique / België
Postal code: 2500
Country: Belgium
E-mail: [email protected]
Internet address: http://www.triumclinicalconsulting.com
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 19
Lot No: 6
Title:

Lot 5A : Clinical Research Safety Services - Clinical Trial Device vigilance/safety services

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: MCRA LLC
National registration number: 861097944
Postal address: 1050 K St NW
Town: Washington
NUTS code: US United States
Postal code: Suite 10
Country: United States
E-mail: [email protected]
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 20
Lot No: 6
Title:

Lot 5A : Clinical Research Safety Services - Clinical Trial Device vigilance/safety services

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: TRIUM Clinical Consulting NV
National registration number: BE0837988839
Postal address: Baron Opsomerlaan 32
Town: LIER
NUTS code: BE Belgique / België
Postal code: 2500
Country: Belgium
E-mail: [email protected]
Internet address: http://www.triumclinicalconsulting.com
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 21
Title:

Lot 5B : Clinical Research Safety Services - Clinical Trial Pharmacovigilance/safety services

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: TRIUM Clinical Consulting NV
National registration number: BE0837988839
Postal address: Baron Opsomerlaan 32
Town: LIER
NUTS code: BE Belgique / België
Postal code: 2500
Country: Belgium
E-mail: [email protected]
Internet address: http://www.triumclinicalconsulting.com
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 22
Lot No: 8
Title:

Lot 6: Clinical Research Services: Clinical Database programming and data management services

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: Afortiori Development
National registration number: E3430005NH
Postal address: Portershed
Town: Galway
NUTS code: IE042 West
Postal code: Galway
Country: Ireland
E-mail: [email protected]
Internet address: http://www.aftdev.com
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 23
Lot No: 8
Title:

Lot 6: Clinical Research Services: Clinical Database programming and data management services

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: DF/Net Research, Inc.
National registration number: 200852149
Postal address: 140 Lakeside Ave., Suite 310
Town: Seattle
NUTS code: US United States
Postal code: 98122
Country: United States
E-mail: [email protected]
Telephone: +1 2064467949
Internet address: http://www.dfnetresearch.com
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 24
Lot No: 8
Title:

Lot 6: Clinical Research Services: Clinical Database programming and data management services

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: MCRA LLC
National registration number: 861097944
Postal address: 1050 K St NW
Town: Washington
NUTS code: US United States
Postal code: Suite 10
Country: United States
E-mail: [email protected]
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 25
Lot No: 8
Title:

Lot 6: Clinical Research Services: Clinical Database programming and data management services

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: Rede Optimus Hospitalar AG
National registration number: CHE-216.455.548 MWST
Postal address: Fröbelstrasse 10
Town: Zürich
NUTS code: CH Schweiz / Suisse / Svizzera
Postal code: 8032
Country: Switzerland
E-mail: [email protected]
Internet address: http://www.rdeoptimus.com.br
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 26
Lot No: 8
Title:

Lot 6: Clinical Research Services: Clinical Database programming and data management services

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: TRIUM Clinical Consulting NV
National registration number: BE0837988839
Postal address: Baron Opsomerlaan 32
Town: LIER
NUTS code: BE Belgique / België
Postal code: 2500
Country: Belgium
E-mail: [email protected]
Internet address: http://www.triumclinicalconsulting.com
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 27
Title:

Lot 7: Clinical Research Services: Validation and Compliance services for clinical trials

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: TRIUM Clinical Consulting NV
National registration number: BE0837988839
Postal address: Baron Opsomerlaan 32
Town: LIER
NUTS code: BE Belgique / België
Postal code: 2500
Country: Belgium
E-mail: [email protected]
Internet address: http://www.triumclinicalconsulting.com
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: 28
Title:

Lot 8: Clinical Research Services: Medical writing and Translation services

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
15/11/2021
V.2.2)Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Official name: TRIUM Clinical Consulting NV
National registration number: BE0837988839
Postal address: Baron Opsomerlaan 32
Town: LIER
NUTS code: BE Belgique / België
Postal code: 2500
Country: Belgium
E-mail: [email protected]
Internet address: http://www.triumclinicalconsulting.com
The contractor is an SME: yes
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section VI: Complementary information

VI.3)Additional information:
VI.4)Procedures for review
VI.4.1)Review body
Official name: Central Office of the High Court
Postal address: Inns Quay
Town: Dublin 7
Country: Ireland
VI.5)Date of dispatch of this notice:
16/11/2021

http://ted.europa.eu/udl?uri=TED:NOTICE:592419-2021:TEXT:EN:HTML&src=0&tabId=2

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