Date of dispatch of this notice: 16/11/2021
External Reference: 2021-235679
TED Reference: 2021/S 225-592419
Contract award notice
Information
Published
Contract award notice
Contract award notice
Results of the procurement procedure
Directive 2014/24/EU
Section I: Contracting authority
I.1)
Name and addresses
National University of Ireland, Galway (NUI Galway)
N/A
University Road
Galway
Galway
IE
Contact person:
Máire Hornibrook
Telephone:
+353 91524411
E-mail:
maire.hornibrook@nuigalway.ie
NUTS code:
IE042 -
West
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
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
Value excluding VAT:
2800000.00
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
Criteria below
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)
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
Criteria below
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)
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.
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
Criteria below
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)
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.
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
Criteria below
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)
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
Criteria below
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)
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
Criteria below
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)
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
Criteria below
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)
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
Criteria below
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)
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.
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
Criteria below
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)
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.
Documentation includes clinical trial contracts, patient information and informed consent forms, study protocol etc.
II.2.5)
Award criteria
Criteria below
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
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
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)
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
:
noV.2.3)
Name and address of the contractor
Afortiori Development
E3430005NH
Portershed
Galway
Galway
IE
E-mail:
nicola@aftdev.com
NUTS code:
IE042 -
West
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:
200000.00
EUR
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)
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
:
noV.2.3)
Name and address of the contractor
MCRA LLC
861097944
1050 K St NW
Washington
Suite 10
US
E-mail:
aobrien@mcra.com
NUTS code:
US -
United States
The contractor is an SME : no
V.2.4)
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot:
200000.00
EUR
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)
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
:
noV.2.3)
Name and address of the contractor
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
E-mail:
info@triumclinicalconsulting.com
NUTS code:
BE -
BELGIQUE-BELGIË
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:
200000.00
EUR
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)
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
:
noV.2.3)
Name and address of the contractor
Afortiori Development
E3430005NH
Portershed
Galway
Galway
IE
E-mail:
nicola@aftdev.com
NUTS code:
IE042 -
West
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:
200000.00
EUR
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)
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
:
noV.2.3)
Name and address of the contractor
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
E-mail:
info@triumclinicalconsulting.com
NUTS code:
BE -
BELGIQUE-BELGIË
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:
200000.00
EUR
Section V: Award of contract
Contract No: 6
Lot No: 3
Title: Lot 2: Clinical Research Services: Quality and Regulatory services for Clinical Trials
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
:
noV.2.3)
Name and address of the contractor
Common Sense Clinical
NL001882722B20
Nieuw-Loosdrechtsedijk140
Loosdrecht
1231LC
NL
E-mail:
sanne@commonsenseclinical.nl
NUTS code:
NL -
NEDERLAND
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:
400000.00
EUR
Section V: Award of contract
Contract No: 7
Lot No: 3
Title: Lot 2: Clinical Research Services: Quality and Regulatory services for Clinical Trials
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
:
noV.2.3)
Name and address of the contractor
MCRA LLC
861097944
1050 K St NW
Washington
Suite 10
US
E-mail:
aobrien@mcra.com
NUTS code:
US -
United States
The contractor is an SME : no
V.2.4)
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot:
400000.00
EUR
Section V: Award of contract
Contract No: 8
Lot No: 3
Title: Lot 2: Clinical Research Services: Quality and Regulatory services for Clinical Trials
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
:
noV.2.3)
Name and address of the contractor
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
E-mail:
info@triumclinicalconsulting.com
NUTS code:
BE -
BELGIQUE-BELGIË
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:
400000.00
EUR
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
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
:
noV.2.3)
Name and address of the contractor
Afortiori Development
E3430005NH
Portershed
Galway
Galway
IE
E-mail:
nicola@aftdev.com
NUTS code:
IE042 -
West
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:
400000.00
EUR
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
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
:
noV.2.3)
Name and address of the contractor
DF/Net Research, Inc.
200852149
140 Lakeside Ave., Suite 310
Seattle
98122
US
Telephone:
+1 2064467949
E-mail:
kevin@dfnetresearch.com
NUTS code:
US -
United States
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:
400000.00
EUR
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
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
:
noV.2.3)
Name and address of the contractor
MCRA LLC
861097944
1050 K St NW
Washington
Suite 10
US
E-mail:
aobrien@mcra.com
NUTS code:
US -
United States
The contractor is an SME : no
V.2.4)
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot:
400000.00
EUR
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
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
:
noV.2.3)
Name and address of the contractor
StatisticaMedica Ltd
9670232P
26 Belarmine Court
Stepaside
D18 TD82
IE
Telephone:
+353 868598777
NUTS code:
IE061 -
Dublin
The contractor is an SME : yes
V.2.4)
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot:
400000.00
EUR
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
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
:
noV.2.3)
Name and address of the contractor
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
E-mail:
info@triumclinicalconsulting.com
NUTS code:
BE -
BELGIQUE-BELGIË
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:
400000.00
EUR
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
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
:
noV.2.3)
Name and address of the contractor
Afortiori Development
E3430005NH
Portershed
Galway
Galway
IE
E-mail:
nicola@aftdev.com
NUTS code:
IE042 -
West
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:
400000.00
EUR
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
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
:
noV.2.3)
Name and address of the contractor
Common Sense Clinical
NL001882722B20
Nieuw-Loosdrechtsedijk140
Loosdrecht
1231LC
NL
E-mail:
sanne@commonsenseclinical.nl
NUTS code:
NL -
NEDERLAND
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:
400000.00
EUR
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
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
:
noV.2.3)
Name and address of the contractor
MCRA LLC
861097944
1050 K St NW
Washington
Suite 10
US
E-mail:
aobrien@mcra.com
NUTS code:
US -
United States
The contractor is an SME : no
V.2.4)
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot:
400000.00
EUR
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
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
:
noV.2.3)
Name and address of the contractor
Rede Optimus Hospitalar AG
CHE-216.455.548 MWST
Fröbelstrasse 10
Zürich
8032
CH
E-mail:
marc.bosiers@telenet.be
NUTS code:
CH -
SCHWEIZ/SUISSE/SVIZZERA
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:
400000.00
EUR
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
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
:
noV.2.3)
Name and address of the contractor
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
E-mail:
info@triumclinicalconsulting.com
NUTS code:
BE -
BELGIQUE-BELGIË
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:
400000.00
EUR
Section V: Award of contract
Contract No: 19
Lot No: 6
Title: Lot 5A : Clinical Research Safety Services - Clinical Trial Device vigilance/safety services
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
:
noV.2.3)
Name and address of the contractor
MCRA LLC
861097944
1050 K St NW
Washington
Suite 10
US
E-mail:
aobrien@mcra.com
NUTS code:
US -
United States
The contractor is an SME : no
V.2.4)
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot:
400000.00
EUR
Section V: Award of contract
Contract No: 20
Lot No: 6
Title: Lot 5A : Clinical Research Safety Services - Clinical Trial Device vigilance/safety services
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
:
noV.2.3)
Name and address of the contractor
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
E-mail:
info@triumclinicalconsulting.com
NUTS code:
BE -
BELGIQUE-BELGIË
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:
400000.00
EUR
Section V: Award of contract
Contract No: 21
Title: Lot 5B : Clinical Research Safety Services - Clinical Trial Pharmacovigilance/safety services
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
:
noV.2.3)
Name and address of the contractor
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
E-mail:
info@triumclinicalconsulting.com
NUTS code:
BE -
BELGIQUE-BELGIË
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:
400000.00
EUR
Section V: Award of contract
Contract No: 22
Lot No: 8
Title: Lot 6: Clinical Research Services: Clinical Database programming and data management services
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
:
noV.2.3)
Name and address of the contractor
Afortiori Development
E3430005NH
Portershed
Galway
Galway
IE
E-mail:
nicola@aftdev.com
NUTS code:
IE042 -
West
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:
400000.00
EUR
Section V: Award of contract
Contract No: 23
Lot No: 8
Title: Lot 6: Clinical Research Services: Clinical Database programming and data management services
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
:
noV.2.3)
Name and address of the contractor
DF/Net Research, Inc.
200852149
140 Lakeside Ave., Suite 310
Seattle
98122
US
Telephone:
+1 2064467949
E-mail:
kevin@dfnetresearch.com
NUTS code:
US -
United States
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:
400000.00
EUR
Section V: Award of contract
Contract No: 24
Lot No: 8
Title: Lot 6: Clinical Research Services: Clinical Database programming and data management services
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
:
noV.2.3)
Name and address of the contractor
MCRA LLC
861097944
1050 K St NW
Washington
Suite 10
US
E-mail:
aobrien@mcra.com
NUTS code:
US -
United States
The contractor is an SME : no
V.2.4)
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot:
400000.00
EUR
Section V: Award of contract
Contract No: 25
Lot No: 8
Title: Lot 6: Clinical Research Services: Clinical Database programming and data management services
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
:
noV.2.3)
Name and address of the contractor
Rede Optimus Hospitalar AG
CHE-216.455.548 MWST
Fröbelstrasse 10
Zürich
8032
CH
E-mail:
marc.bosiers@telenet.be
NUTS code:
CH -
SCHWEIZ/SUISSE/SVIZZERA
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:
400000.00
EUR
Section V: Award of contract
Contract No: 26
Lot No: 8
Title: Lot 6: Clinical Research Services: Clinical Database programming and data management services
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
:
noV.2.3)
Name and address of the contractor
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
E-mail:
info@triumclinicalconsulting.com
NUTS code:
BE -
BELGIQUE-BELGIË
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:
400000.00
EUR
Section V: Award of contract
Contract No: 27
Title: Lot 7: Clinical Research Services: Validation and Compliance services for clinical trials
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
:
noV.2.3)
Name and address of the contractor
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
E-mail:
info@triumclinicalconsulting.com
NUTS code:
BE -
BELGIQUE-BELGIË
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:
400000.00
EUR
Section V: Award of contract
Contract No: 28
Title: Lot 8: Clinical Research Services: Medical writing and Translation services
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
:
noV.2.3)
Name and address of the contractor
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
E-mail:
info@triumclinicalconsulting.com
NUTS code:
BE -
BELGIQUE-BELGIË
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:
400000.00
EUR
Section VI: Complementary information
VI.4)
Procedures for review
VI.4.1)
Review body
Central Office of the High Court
Inns Quay
Dublin 7
IE