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
[NoticeContractAward]
[NoticeContractAwardSub]
[Directive201424]
[Section1]: [Ca]
I.1)
[NameAddressContact]
National University of Ireland, Galway (NUI Galway)
N/A
University Road
Galway
Galway
IE
[Contactpoint]:
Máire Hornibrook
[AddressPhone]:
+353 91524411
[AddressEmail]:
maire.hornibrook@nuigalway.ie
[Nutscode]:
IE042 -
West
[UrlGeneral]:
http://www.nuigalway.ie
[UrlBuyerprofile]:
https://irl.eu-supply.com/ctm/Company/CompanyInformation/Index/414
I.4)
[CaType]
[MaintypePublicbody]
I.5)
[Mainactivity]
[MainactivEducation]
[Section2]: [Object]
II.1)
[QuantityScopeContract]
II.1.1)
[TitleContract]
Clinical Research Services in 10 Lots
[Fileref]:
NUIG/CON1218/2020
II.1.2)
[CpvMain]
73110000
-
II.1.3)
[TypeContract]
[Services]
II.1.4)
[DescrShort]
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)
[LotsInfo]
[DivisionLots]:
[Yes]
II.1.7)
[ValueTotal]
[ValueExclVat]:
2800000.00
EUR
II.2)
[Description]
II.2.1)
[TitleContract]
Lot 1A: Clinical Research Full Service - Device Trials (Full Service including financial invoicing)
[LotNumber]:
1A
II.2.2)
[CpvAdditional]
73000000
-
73100000
-
73111000
-
73200000
-
73210000
-
79530000
-
II.2.3)
[PlacePerformance]
[Nutscode]:
IE042 -
West
II.2.4)
[DescrProcurement]
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)
[AwardCriteria]
[AwardCriteriaBelow]
[AwardCriterionQuality]
-
[AwardCriterionName]:
Understanding of Brief and Proposed Methodology
/
[Weighting]:
50
[AwardCriterionQuality]
-
[AwardCriterionName]:
Quality of Team Proposed
/
[Weighting]:
30
[Price]
-
[Weighting]:
20
II.2.11)
[OptionsInfo]
[Options]:
[No]
II.2.13)
[EuProgrInfo]
[EuProgrRelated]:
[No]
II.2)
[Description]
II.2.1)
[TitleContract]
Lot 1B: Clinical Research Full Service - Pharma Trials (Full Service including financial invoicing)
[LotNumber]:
1B
II.2.2)
[CpvAdditional]
73000000
-
73100000
-
73111000
-
73200000
-
73210000
-
79530000
-
II.2.3)
[PlacePerformance]
[Nutscode]:
IE042 -
West
II.2.4)
[DescrProcurement]
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)
[AwardCriteria]
[AwardCriteriaBelow]
[AwardCriterionQuality]
-
[AwardCriterionName]:
Understanding of Brief and Proposed Methodology
/
[Weighting]:
50
[AwardCriterionQuality]
-
[AwardCriterionName]:
Quality of Team Proposed
/
[Weighting]:
30
[Price]
-
[Weighting]:
20
II.2.11)
[OptionsInfo]
[Options]:
[No]
II.2.13)
[EuProgrInfo]
[EuProgrRelated]:
[No]
II.2)
[Description]
II.2.1)
[TitleContract]
Lot 2: Clinical Research Services: Quality and Regulatory services for Clinical Trials
[LotNumber]:
2
II.2.2)
[CpvAdditional]
73000000
-
73100000
-
73111000
-
73200000
-
73210000
-
79530000
-
II.2.3)
[PlacePerformance]
[Nutscode]:
IE042 -
West
II.2.4)
[DescrProcurement]
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)
[AwardCriteria]
[AwardCriteriaBelow]
[AwardCriterionQuality]
-
[AwardCriterionName]:
Understanding of Brief and Proposed Methodology
/
[Weighting]:
50
[AwardCriterionQuality]
-
[AwardCriterionName]:
Quality of Team Proposed
/
[Weighting]:
30
[Price]
-
[Weighting]:
20
II.2.11)
[OptionsInfo]
[Options]:
[No]
II.2.13)
[EuProgrInfo]
[EuProgrRelated]:
[No]
II.2)
[Description]
II.2.1)
[TitleContract]
Lot 3: Clinical Research Services: Biostatistics and Clinical Study Design services for Clinical Tri
[LotNumber]:
3
II.2.2)
[CpvAdditional]
73000000
-
73100000
-
73111000
-
73200000
-
73210000
-
79530000
-
II.2.3)
[PlacePerformance]
[Nutscode]:
IE042 -
West
II.2.4)
[DescrProcurement]
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)
[AwardCriteria]
[AwardCriteriaBelow]
[AwardCriterionQuality]
-
[AwardCriterionName]:
Understanding of Brief and Proposed Methodology
/
[Weighting]:
50
[AwardCriterionQuality]
-
[AwardCriterionName]:
Quality of Team Proposed
/
[Weighting]:
30
[Price]
-
[Weighting]:
20
II.2.11)
[OptionsInfo]
[Options]:
[No]
II.2.13)
[EuProgrInfo]
[EuProgrRelated]:
[No]
II.2)
[Description]
II.2.1)
[TitleContract]
Lot 4: Clinical Research Services: Study Co-ordination & Management services for Clinical Trials
[LotNumber]:
4
II.2.2)
[CpvAdditional]
73000000
-
73100000
-
73111000
-
73200000
-
73210000
-
79530000
-
II.2.3)
[PlacePerformance]
[Nutscode]:
IE042 -
West
II.2.4)
[DescrProcurement]
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)
[AwardCriteria]
[AwardCriteriaBelow]
[AwardCriterionQuality]
-
[AwardCriterionName]:
Understanding of Brief and Proposed Methodology
/
[Weighting]:
50
[AwardCriterionQuality]
-
[AwardCriterionName]:
Quality of Team Proposed
/
[Weighting]:
30
[Price]
-
[Weighting]:
20
II.2.11)
[OptionsInfo]
[Options]:
[No]
II.2.13)
[EuProgrInfo]
[EuProgrRelated]:
[No]
II.2)
[Description]
II.2.1)
[TitleContract]
Lot 5A : Clinical Research Safety Services - Clinical Trial Device vigilance/safety services
[LotNumber]:
5A
II.2.2)
[CpvAdditional]
73000000
-
73100000
-
73111000
-
73200000
-
73210000
-
79530000
-
II.2.3)
[PlacePerformance]
[Nutscode]:
IE042 -
West
II.2.4)
[DescrProcurement]
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)
[AwardCriteria]
[AwardCriteriaBelow]
[AwardCriterionQuality]
-
[AwardCriterionName]:
Understanding of Brief and Proposed Methodology
/
[Weighting]:
50
[AwardCriterionQuality]
-
[AwardCriterionName]:
Quality of Team Proposed
/
[Weighting]:
30
[Price]
-
[Weighting]:
20
II.2.11)
[OptionsInfo]
[Options]:
[No]
II.2.13)
[EuProgrInfo]
[EuProgrRelated]:
[No]
II.2)
[Description]
II.2.1)
[TitleContract]
Lot 5B : Clinical Research Safety Services - Clinical Trial Pharmacovigilance/safety services
[LotNumber]:
5B
II.2.2)
[CpvAdditional]
73000000
-
73100000
-
73111000
-
73200000
-
73210000
-
79530000
-
II.2.3)
[PlacePerformance]
[Nutscode]:
IE042 -
West
II.2.4)
[DescrProcurement]
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)
[AwardCriteria]
[AwardCriteriaBelow]
[AwardCriterionQuality]
-
[AwardCriterionName]:
Understanding of Brief and Proposed Methodology
/
[Weighting]:
50
[AwardCriterionQuality]
-
[AwardCriterionName]:
Quality of Team Proposed
/
[Weighting]:
30
[Price]
-
[Weighting]:
20
II.2.11)
[OptionsInfo]
[Options]:
[No]
II.2.13)
[EuProgrInfo]
[EuProgrRelated]:
[No]
II.2)
[Description]
II.2.1)
[TitleContract]
Lot 6: Clinical Research Services: Clinical Database programming and data management services
[LotNumber]:
6
II.2.2)
[CpvAdditional]
73000000
-
73100000
-
73111000
-
73200000
-
73210000
-
79530000
-
II.2.3)
[PlacePerformance]
[Nutscode]:
IE042 -
West
II.2.4)
[DescrProcurement]
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)
[AwardCriteria]
[AwardCriteriaBelow]
[AwardCriterionQuality]
-
[AwardCriterionName]:
Understanding of Brief and Proposed Methodology
/
[Weighting]:
50
[AwardCriterionQuality]
-
[AwardCriterionName]:
Quality of Team Proposed
/
[Weighting]:
30
[Price]
-
[Weighting]:
20
II.2.11)
[OptionsInfo]
[Options]:
[No]
II.2.13)
[EuProgrInfo]
[EuProgrRelated]:
[No]
II.2)
[Description]
II.2.1)
[TitleContract]
Lot 7: Clinical Research Services: Validation and Compliance services for clinical trials
[LotNumber]:
7
II.2.2)
[CpvAdditional]
73000000
-
73100000
-
73111000
-
73200000
-
73210000
-
79530000
-
II.2.3)
[PlacePerformance]
[Nutscode]:
IE042 -
West
II.2.4)
[DescrProcurement]
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)
[AwardCriteria]
[AwardCriteriaBelow]
[AwardCriterionQuality]
-
[AwardCriterionName]:
Understanding of Brief and Proposed Methodology
/
[Weighting]:
50
[AwardCriterionQuality]
-
[AwardCriterionName]:
Quality of Team Proposed
/
[Weighting]:
30
[Price]
-
[Weighting]:
20
II.2.11)
[OptionsInfo]
[Options]:
[No]
II.2.13)
[EuProgrInfo]
[EuProgrRelated]:
[No]
II.2)
[Description]
II.2.1)
[TitleContract]
Lot 8: Clinical Research Services: Medical writing and Translation services
[LotNumber]:
8
II.2.2)
[CpvAdditional]
79530000
-
II.2.3)
[PlacePerformance]
[Nutscode]:
IE042 -
West
II.2.4)
[DescrProcurement]
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)
[AwardCriteria]
[AwardCriteriaBelow]
[AwardCriterionQuality]
-
[AwardCriterionName]:
Understanding of Brief and Proposed Methdology
/
[Weighting]:
50
[AwardCriterionQuality]
-
[AwardCriterionName]:
Quality of Team Proposed
/
[Weighting]:
30
[Price]
-
[Weighting]:
20
II.2.11)
[OptionsInfo]
[Options]:
[No]
II.2.13)
[EuProgrInfo]
[EuProgrRelated]:
[No]
[Section4]: [Procedure]
IV.1)
[Description]
IV.1.1)
[TypeProcedure]
[ProctypeOpen]
IV.1.3)
[FrameworkContractDpsInfo]
[NoticeInvolvesFramework]
IV.1.8)
[GpaInfo]
[GpaCovered]
: [Yes]
IV.2)
[InfoAdmin]
IV.2.1)
[PubPrevious]
[NumberOj]: 2021/S 063-160281
[Section5]: [AwardOfContract]
[ContractNumber]: 1
[LotNumber]: 1
[TitleContract]: Lot 1A: Clinical Research Full Service - Device Trials (Full Service including financial invoicing)
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
Afortiori Development
E3430005NH
Portershed
Galway
Galway
IE
[AddressEmail]:
nicola@aftdev.com
[Nutscode]:
IE042 -
West
[Internet]:
http://www.aftdev.com
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
200000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 2
[LotNumber]: 1
[TitleContract]: Lot 1A: Clinical Research Full Service - Device Trials (Full Service including financial invoicing)
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
MCRA LLC
861097944
1050 K St NW
Washington
Suite 10
US
[AddressEmail]:
aobrien@mcra.com
[Nutscode]:
US -
United States
[AwardedSme] : [No]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
200000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 3
[LotNumber]: 1
[TitleContract]: Lot 1A: Clinical Research Full Service - Device Trials (Full Service including financial invoicing)
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
[AddressEmail]:
info@triumclinicalconsulting.com
[Nutscode]:
BE -
BELGIQUE-BELGIË
[Internet]:
http://www.triumclinicalconsulting.com
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
200000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 4
[LotNumber]: 2
[TitleContract]: Lot 1B: Clinical Research Full Service - Pharma Trials (Full Service including financial invoicing)
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
Afortiori Development
E3430005NH
Portershed
Galway
Galway
IE
[AddressEmail]:
nicola@aftdev.com
[Nutscode]:
IE042 -
West
[Internet]:
http://www.aftdev.com
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
200000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 5
[LotNumber]: 2
[TitleContract]: Lot 1B: Clinical Research Full Service - Pharma Trials (Full Service including financial invoicing)
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
[AddressEmail]:
info@triumclinicalconsulting.com
[Nutscode]:
BE -
BELGIQUE-BELGIË
[Internet]:
http://www.triumclinicalconsulting.com
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
200000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 6
[LotNumber]: 3
[TitleContract]: Lot 2: Clinical Research Services: Quality and Regulatory services for Clinical Trials
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
Common Sense Clinical
NL001882722B20
Nieuw-Loosdrechtsedijk140
Loosdrecht
1231LC
NL
[AddressEmail]:
sanne@commonsenseclinical.nl
[Nutscode]:
NL -
NEDERLAND
[Internet]:
http://www.commonsenseclinical.nl
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 7
[LotNumber]: 3
[TitleContract]: Lot 2: Clinical Research Services: Quality and Regulatory services for Clinical Trials
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
MCRA LLC
861097944
1050 K St NW
Washington
Suite 10
US
[AddressEmail]:
aobrien@mcra.com
[Nutscode]:
US -
United States
[AwardedSme] : [No]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 8
[LotNumber]: 3
[TitleContract]: Lot 2: Clinical Research Services: Quality and Regulatory services for Clinical Trials
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
[AddressEmail]:
info@triumclinicalconsulting.com
[Nutscode]:
BE -
BELGIQUE-BELGIË
[Internet]:
http://www.triumclinicalconsulting.com
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 9
[LotNumber]: 4
[TitleContract]: Lot 3: Clinical Research Services: Biostatistics and Clinical Study Design services for Clinical Tri
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
Afortiori Development
E3430005NH
Portershed
Galway
Galway
IE
[AddressEmail]:
nicola@aftdev.com
[Nutscode]:
IE042 -
West
[Internet]:
http://www.aftdev.com
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 10
[LotNumber]: 4
[TitleContract]: Lot 3: Clinical Research Services: Biostatistics and Clinical Study Design services for Clinical Tri
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
DF/Net Research, Inc.
200852149
140 Lakeside Ave., Suite 310
Seattle
98122
US
[AddressPhone]:
+1 2064467949
[AddressEmail]:
kevin@dfnetresearch.com
[Nutscode]:
US -
United States
[Internet]:
http://www.dfnetresearch.com
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 11
[LotNumber]: 4
[TitleContract]: Lot 3: Clinical Research Services: Biostatistics and Clinical Study Design services for Clinical Tri
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
MCRA LLC
861097944
1050 K St NW
Washington
Suite 10
US
[AddressEmail]:
aobrien@mcra.com
[Nutscode]:
US -
United States
[AwardedSme] : [No]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 12
[LotNumber]: 4
[TitleContract]: Lot 3: Clinical Research Services: Biostatistics and Clinical Study Design services for Clinical Tri
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
StatisticaMedica Ltd
9670232P
26 Belarmine Court
Stepaside
D18 TD82
IE
[AddressPhone]:
+353 868598777
[AddressEmail]:
gloria.crispino@statisticamedica.com
[Nutscode]:
IE061 -
Dublin
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 13
[LotNumber]: 4
[TitleContract]: Lot 3: Clinical Research Services: Biostatistics and Clinical Study Design services for Clinical Tri
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
[AddressEmail]:
info@triumclinicalconsulting.com
[Nutscode]:
BE -
BELGIQUE-BELGIË
[Internet]:
http://www.triumclinicalconsulting.com
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 14
[LotNumber]: 5
[TitleContract]: Lot 4: Clinical Research Services: Study Co-ordination & Management services for Clinical Trials
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
Afortiori Development
E3430005NH
Portershed
Galway
Galway
IE
[AddressEmail]:
nicola@aftdev.com
[Nutscode]:
IE042 -
West
[Internet]:
http://www.aftdev.com
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 15
[LotNumber]: 5
[TitleContract]: Lot 4: Clinical Research Services: Study Co-ordination & Management services for Clinical Trials
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
Common Sense Clinical
NL001882722B20
Nieuw-Loosdrechtsedijk140
Loosdrecht
1231LC
NL
[AddressEmail]:
sanne@commonsenseclinical.nl
[Nutscode]:
NL -
NEDERLAND
[Internet]:
http://www.commonsenseclinical.nl
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 16
[LotNumber]: 5
[TitleContract]: Lot 4: Clinical Research Services: Study Co-ordination & Management services for Clinical Trials
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
MCRA LLC
861097944
1050 K St NW
Washington
Suite 10
US
[AddressEmail]:
aobrien@mcra.com
[Nutscode]:
US -
United States
[AwardedSme] : [No]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 17
[LotNumber]: 5
[TitleContract]: Lot 4: Clinical Research Services: Study Co-ordination & Management services for Clinical Trials
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
Rede Optimus Hospitalar AG
CHE-216.455.548 MWST
Fröbelstrasse 10
Zürich
8032
CH
[AddressEmail]:
marc.bosiers@telenet.be
[Nutscode]:
CH -
SCHWEIZ/SUISSE/SVIZZERA
[Internet]:
http://www.rdeoptimus.com.br
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 18
[LotNumber]: 5
[TitleContract]: Lot 4: Clinical Research Services: Study Co-ordination & Management services for Clinical Trials
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
[AddressEmail]:
info@triumclinicalconsulting.com
[Nutscode]:
BE -
BELGIQUE-BELGIË
[Internet]:
http://www.triumclinicalconsulting.com
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 19
[LotNumber]: 6
[TitleContract]: Lot 5A : Clinical Research Safety Services - Clinical Trial Device vigilance/safety services
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
MCRA LLC
861097944
1050 K St NW
Washington
Suite 10
US
[AddressEmail]:
aobrien@mcra.com
[Nutscode]:
US -
United States
[AwardedSme] : [No]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 20
[LotNumber]: 6
[TitleContract]: Lot 5A : Clinical Research Safety Services - Clinical Trial Device vigilance/safety services
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
[AddressEmail]:
info@triumclinicalconsulting.com
[Nutscode]:
BE -
BELGIQUE-BELGIË
[Internet]:
http://www.triumclinicalconsulting.com
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 21
[TitleContract]: Lot 5B : Clinical Research Safety Services - Clinical Trial Pharmacovigilance/safety services
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
[AddressEmail]:
info@triumclinicalconsulting.com
[Nutscode]:
BE -
BELGIQUE-BELGIË
[Internet]:
http://www.triumclinicalconsulting.com
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 22
[LotNumber]: 8
[TitleContract]: Lot 6: Clinical Research Services: Clinical Database programming and data management services
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
Afortiori Development
E3430005NH
Portershed
Galway
Galway
IE
[AddressEmail]:
nicola@aftdev.com
[Nutscode]:
IE042 -
West
[Internet]:
http://www.aftdev.com
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 23
[LotNumber]: 8
[TitleContract]: Lot 6: Clinical Research Services: Clinical Database programming and data management services
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
DF/Net Research, Inc.
200852149
140 Lakeside Ave., Suite 310
Seattle
98122
US
[AddressPhone]:
+1 2064467949
[AddressEmail]:
kevin@dfnetresearch.com
[Nutscode]:
US -
United States
[Internet]:
http://www.dfnetresearch.com
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 24
[LotNumber]: 8
[TitleContract]: Lot 6: Clinical Research Services: Clinical Database programming and data management services
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
MCRA LLC
861097944
1050 K St NW
Washington
Suite 10
US
[AddressEmail]:
aobrien@mcra.com
[Nutscode]:
US -
United States
[AwardedSme] : [No]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 25
[LotNumber]: 8
[TitleContract]: Lot 6: Clinical Research Services: Clinical Database programming and data management services
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
Rede Optimus Hospitalar AG
CHE-216.455.548 MWST
Fröbelstrasse 10
Zürich
8032
CH
[AddressEmail]:
marc.bosiers@telenet.be
[Nutscode]:
CH -
SCHWEIZ/SUISSE/SVIZZERA
[Internet]:
http://www.rdeoptimus.com.br
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 26
[LotNumber]: 8
[TitleContract]: Lot 6: Clinical Research Services: Clinical Database programming and data management services
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
[AddressEmail]:
info@triumclinicalconsulting.com
[Nutscode]:
BE -
BELGIQUE-BELGIË
[Internet]:
http://www.triumclinicalconsulting.com
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 27
[TitleContract]: Lot 7: Clinical Research Services: Validation and Compliance services for clinical trials
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
[AddressEmail]:
info@triumclinicalconsulting.com
[Nutscode]:
BE -
BELGIQUE-BELGIË
[Internet]:
http://www.triumclinicalconsulting.com
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section5]: [AwardOfContract]
[ContractNumber]: 28
[TitleContract]: Lot 8: Clinical Research Services: Medical writing and Translation services
V.2)
[AwardOfContract]
V.2.1)
[DateAward]
15/11/2021
V.2.2)
[AwardOffersInfo]
[OffersReceived]:
10
[OffersReceivedElectronic]:
10
[AwardedGroup]
:
[No]V.2.3)
[AwardedToName]
TRIUM Clinical Consulting NV
BE0837988839
Baron Opsomerlaan 32
LIER
2500
BE
[AddressEmail]:
info@triumclinicalconsulting.com
[Nutscode]:
BE -
BELGIQUE-BELGIË
[Internet]:
http://www.triumclinicalconsulting.com
[AwardedSme] : [Yes]
V.2.4)
[ValueContractInfo] ([ExclVat])
[ValueTotalFinal]:
400000.00
EUR
[Section6]: [InfoComplement]
VI.4)
[AppealsProcedure]
VI.4.1)
[AppealsBody]
Central Office of the High Court
Inns Quay
Dublin 7
IE