Date of dispatch of this notice: 26/03/2021
Expire date: 04/05/2021
External Reference: 2021-298227
TED Reference: 2021/S 063-160281
Contract notice
Information
Published
Contract notice
Contract notice
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:
Frances Feeney
Telephone:
+353 91524411
E-mail:
frances.feeney@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.3)
Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at:
http://irl.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=185563&B=ETENDERS_SIMPLEAdditional information can be obtained from
the abovementioned address:
Tenders or requests to participate must be submitted
electronically via:
http://irl.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=185563&B=ETENDERS_SIMPLE
Tenders or requests to participate must be submitted
to the abovementioned address
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
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 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.1.5)
Estimated total value
Value excluding VAT: 2800000.00
EUR
II.1.6)
Information about lots
This contract is divided into lots:
yes
Tenders may be submitted for
all lots
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
Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.7)
Duration of the contract, framework agreement or dynamic purchasing system
Duration in months:
24
This contract is subject to renewal:
yes
Description of renewals:
The framework agreement will be established for a period of two (2) years, with the option to extend same for a further period of one (1) year, on up to two occasions, subject to a maximum overall term of four (4) years, subject to satisfactory performance, business needs and budgetary constraints.
II.2.10)
Information about variants
Variants will be accepted:
no
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
Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.7)
Duration of the contract, framework agreement or dynamic purchasing system
Duration in months:
24
This contract is subject to renewal:
yes
Description of renewals:
The framework agreement will be established for a period of two (2) years, with the option to extend same for a further period of one (1) year, on up to two occasions, subject to a maximum overall term of four (4) years, subject to satisfactory performance, business needs and budgetary constraints.
II.2.10)
Information about variants
Variants will be accepted:
no
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
Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.7)
Duration of the contract, framework agreement or dynamic purchasing system
Duration in months:
24
This contract is subject to renewal:
yes
Description of renewals:
The framework agreement will be established for a period of two (2) years, with the option to extend same for a further period of one (1) year, on up to two occasions, subject to a maximum overall term of four (4) years, subject to satisfactory performance, business needs and budgetary constraints.
II.2.10)
Information about variants
Variants will be accepted:
no
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
Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.7)
Duration of the contract, framework agreement or dynamic purchasing system
Duration in months:
24
This contract is subject to renewal:
yes
Description of renewals:
The framework agreement will be established for a period of two (2) years, with the option to extend same for a further period of one (1) year, on up to two occasions, subject to a maximum overall term of four (4) years, subject to satisfactory performance, business needs and budgetary constraints.
II.2.10)
Information about variants
Variants will be accepted:
no
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
Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.7)
Duration of the contract, framework agreement or dynamic purchasing system
Duration in months:
24
This contract is subject to renewal:
yes
Description of renewals:
The framework agreement will be established for a period of two (2) years, with the option to extend same for a further period of one (1) year, on up to two occasions, subject to a maximum overall term of four (4) years, subject to satisfactory performance, business needs and budgetary constraints.
II.2.10)
Information about variants
Variants will be accepted:
no
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
Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.7)
Duration of the contract, framework agreement or dynamic purchasing system
Duration in months:
24
This contract is subject to renewal:
yes
Description of renewals:
The framework agreement will be established for a period of two (2) years, with the option to extend same for a further period of one (1) year, on up to two occasions, subject to a maximum overall term of four (4) years, subject to satisfactory performance, business needs and budgetary constraints.
II.2.10)
Information about variants
Variants will be accepted:
no
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
Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.7)
Duration of the contract, framework agreement or dynamic purchasing system
Duration in months:
24
This contract is subject to renewal:
yes
Description of renewals:
The framework agreement will be established for a period of two (2) years, with the option to extend same for a further period of one (1) year, on up to two occasions, subject to a maximum overall term of four (4) years, subject to satisfactory performance, business needs and budgetary constraints.
II.2.10)
Information about variants
Variants will be accepted:
no
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
Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.7)
Duration of the contract, framework agreement or dynamic purchasing system
Duration in months:
24
This contract is subject to renewal:
yes
Description of renewals:
The framework agreement will be established for a period of two (2) years, with the option to extend same for a further period of one (1) year, on up to two occasions, subject to a maximum overall term of four (4) years, subject to satisfactory performance, business needs and budgetary constraints.
II.2.10)
Information about variants
Variants will be accepted:
no
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
Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.7)
Duration of the contract, framework agreement or dynamic purchasing system
Duration in months:
24
This contract is subject to renewal:
yes
Description of renewals:
The framework agreement will be established for a period of two (2) years, with the option to extend same for a further period of one (1) year, on up to two occasions, subject to a maximum overall term of four (4) years, subject to satisfactory performance, business needs and budgetary constraints.
II.2.10)
Information about variants
Variants will be accepted:
no
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
Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.7)
Duration of the contract, framework agreement or dynamic purchasing system
Duration in months:
24
This contract is subject to renewal:
yes
Description of renewals:
The framework agreement will be established for a period of two (2) years, with the option to extend same for a further period of one (1) year, on up to two occasions, subject to a maximum overall term of four (4) years, subject to satisfactory performance, business needs and budgetary constraints.
II.2.10)
Information about variants
Variants will be accepted:
no
II.2.11)
Information about options
Options:
no
II.2.13)
Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds:
no
Section III: Legal, economic, financial and technical information
III.1)
Conditions for participation
III.1.2)
Economic and financial standing
Selection criteria as stated in the procurement documents
III.1.3)
Technical and professional ability
Selection criteria as stated in the procurement documents
III.2)
Conditions related to the contract
III.2.3)
Information about staff responsible for the performance of the contract
Obligation to indicate the names and professional qualifications of the staff assigned to performing the contract
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
Framework agreement with several operators
Envisaged maximum number of participants to the framework agreement:
48
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.2.2)
Time limit for receipt of tenders or requests to participate
Date:
26/04/2021
Local time:
14:00
IV.2.4)
Languages in which tenders or requests to participate may be submitted
English
IV.2.6)
Minimum time frame during which the tenderer must maintain the tender
Duration in months
: 12
(from the date stated for receipt of tender)
IV.2.7)
Conditions for opening of tenders
Date:
26/04/2021
Local time:
14:00
Section VI: Complementary information
VI.1)
Information about recurrence
This is a recurrent procurement:
yes
Estimated timing for further notices to be published:
26.09.2024
VI.2)
Information about electronic workflows
Electronic ordering will be used
Electronic invoicing will be accepted
Electronic payment will be used
VI.4)
Procedures for review
VI.4.1)
Review body
Central Office of the High Court
Inns Quay
Dublin 7
IE