Clinical Research Services in Ten Lots

National University of Ireland, Galway (NUI Galway)

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 and 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.

Deadline

The time limit for receipt of tenders was 2021-04-26. The procurement was published on 2021-03-26.

Suppliers

The following suppliers are mentioned in award decisions or other procurement documents:

Who? What? Where?
Procurement history
Date Document
2021-03-26 Contract notice
2021-04-22 Additional information
2021-11-16 Contract award notice
Contract notice (2021-03-26)
Object
Scope of the procurement
Title: Research services
Reference number: NUIG/CON1218/2020
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 and 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.
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Notice metadata
Original language: English 🗣️
Document type: Contract notice
Nature of contract: Services
Regulation: European Union, with participation of GPA countries
Common procurement vocabulary (CPV)
Code: Research services 📦
Additional CPV: Research and development services and related consultancy services 📦
Translation services 📦
Place of performance
NUTS region: West 🏙️

Procedure
Procedure type: Open procedure
Type of bid: Submission for all lots
Award criteria
The most economic tender

Contracting authority
Identity
Country: Ireland 🇮🇪
Awarding authority type: Body governed by public law
Awarding authority name: National University of Ireland, Galway (NUI Galway)
Postal address: University Road
Postal town: Galway
Contact
Internet address: http://www.nuigalway.ie 🌏
E-mail: frances.feeney@nuigalway.ie 📧
Phone: +353 91524411 📞
URL for documents: http://irl.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=185563&B=ETENDERS_SIMPLE 🌏
URL for participation: http://irl.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=185563&B=ETENDERS_SIMPLE 🌏

Reference
Dates
Date dispatched: 2021-03-26 📅
Submission deadline: 2021-04-26 📅
Publication date: 2021-03-31 📅
Identifiers
Notice number: 2021/S 063-160281
OJ-S issue: 63

Object
Scope of the procurement
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 and 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.
Estimated total value: 2 800 000 EUR 💰
Title of the lot: Lot 1A: Clinical Research Full Service — Device Trials (Full Service Including Financial Invoicing)
Lot number: 1A
Short description:
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).
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Duration: 24 months
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.
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Title of the lot: Lot 1B: Clinical Research Full Service — Pharma Trials (Full Service Including Financial Invoicing)
Lot number: 1B
Short description:
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).
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Title of the lot: Lot 2: Clinical Research Services: Quality and Regulatory services for Clinical Trials
Lot number: 2
Short description:
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.
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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.
Title of the lot: Lot 3: Clinical Research Services: Biostatistics and Clinical Study Design Services for Clinical Trials
Lot number: 3
Short description:
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.
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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.
Title of the lot: Lot 4: Clinical Research Services: Study Co-ordination and Management services for Clinical Trials
Lot number: 4
Short description:
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.
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Title of the lot: Lot 5A: Clinical Research Safety Services — Clinical Trial Device Vigilance/Safety Services
Lot number: 5A
Short description:
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.
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Title of the lot: Lot 5B: Clinical Research Safety Services — Clinical Trial Pharmacovigilance/Safety Services
Lot number: 5B
Short description:
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.
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Title of the lot: Lot 6: Clinical Research Services: Clinical Database Programming and Data Management Services
Lot number: 6
Short description:
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 finalisation, 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.
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Title of the lot: Lot 7: Clinical Research Services: Validation and Compliance services for Clinical Trials
Lot number: 7
Short description:
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.
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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.
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Support for audit readiness and audit compliance activities with regard to computer system compliance as required per GAMP 5 and any applicable regulatory requirements.
Title of the lot: Lot 8: Clinical Research Services: Medical Writing and Translation Services
Lot number: 8
Short description:
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.

Procedure
Legal basis: 32014L0024
Number of participants to be contemplated: 48
Time of receipt of tenders: 14:00
Languages in which tenders or requests to participate may be submitted: English 🗣️
Tender validity period: 12 months
Tender opening date: 2021-04-26 📅
Tender opening time: 14:00

Contracting authority
Identity
National registration number: N/a
Contact
Contact point: Frances Feeney
Address of the buyer profile: https://irl.eu-supply.com/ctm/Company/CompanyInformation/Index/414 🌏
Documents URL: http://irl.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=185563&B=ETENDERS_SIMPLE 🌏

Reference
Additional information
Estimated timing for further notices: 26 September 2024.

Complementary information
Review body
Name: Central Office of the High Court
Postal address: Inns Quay
Postal town: Dublin 7
Country: Ireland 🇮🇪
Source: OJS 2021/S 063-160281 (2021-03-26)
Additional information (2021-04-22)
Object
Scope of the procurement
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 and 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.
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Notice metadata
Document type: Additional information

Reference
Dates
Date dispatched: 2021-04-22 📅
Publication date: 2021-04-27 📅
Identifiers
Notice number: 2021/S 081-209529
Refers to notice: 2021/S 063-160281
OJ-S issue: 81
Additional information
The deadline for Tender Responses has been extended to Tuesday 4 May 2021 at 10 a.m. Irish time.

Object
Scope of the procurement
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 and 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.
Source: OJS 2021/S 081-209529 (2021-04-22)
Contract award notice (2021-11-16)
Object
Scope of the procurement
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
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Total value of the procurement: 2 800 000 EUR 💰
Notice metadata
Document type: Contract award notice

Procedure
Type of bid: Not applicable

Contracting authority
Identity
Postal code: Galway
Contact
E-mail: maire.hornibrook@nuigalway.ie 📧

Reference
Dates
Date dispatched: 2021-11-16 📅
Publication date: 2021-11-19 📅
Identifiers
Notice number: 2021/S 225-592419
OJ-S issue: 225

Object
Scope of the procurement
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
Title of the lot: Lot 1A: Clinical Research Full Service - Device Trials (Full Service including financial invoicing)
Short description:
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).
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Title of the lot: Lot 1B: Clinical Research Full Service - Pharma Trials (Full Service including financial invoicing)
Short description:
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).
Show more
Title of the lot: Lot 3: Clinical Research Services: Biostatistics and Clinical Study Design services for Clinical Tri
Short description:
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.
Show more
Title of the lot: 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
Short description:
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.
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Title of the lot: Lot 6: Clinical Research Services: Clinical Database programming and data management services
Short description:
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.
Show more
Title of the lot: Lot 7: Clinical Research Services: Validation and Compliance services for clinical trials
Short description:
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.
Show more
Title of the lot: Lot 8: Clinical Research Services: Medical writing and Translation services
Short description:
Support the certified translation of Medical and legal documentation associated with the delivery of the clinical research programme ongoing with the Research centre.

Procedure
Award criteria
Quality criterion (name): Understanding of Brief and Proposed Methodology
Quality criterion (weighting): 50
Quality criterion (name): Quality of Team Proposed
Quality criterion (weighting): 30
Price (weighting): 20
Quality criterion (name): Understanding of Brief and Proposed Methdology

Award of contract
Date of contract conclusion: 2021-11-15 📅
Name: Afortiori Development
National registration number: E3430005NH
Postal address: Portershed
Postal town: Galway
Postal code: Galway
Country: Ireland 🇮🇪
E-mail: nicola@aftdev.com 📧
Country: West 🏙️
Internet address: http://www.aftdev.com 🌏
Total value of the procurement: 200 000 EUR 💰
Name: Mcra llc
National registration number: 861097944
Postal address: 1050 K St NW
Postal town: Washington
Postal code: Suite 10
Country: United States 🇺🇸
E-mail: aobrien@mcra.com 📧
Name: TRIUM Clinical Consulting NV
National registration number: BE0837988839
Postal address: Baron Opsomerlaan 32
Postal town: Lier
Postal code: 2500
Country: Belgium 🇧🇪
E-mail: info@triumclinicalconsulting.com 📧
Internet address: http://www.triumclinicalconsulting.com 🌏
Name: Common Sense Clinical
National registration number: NL001882722B20
Postal address: Nieuw-Loosdrechtsedijk140
Postal town: Loosdrecht
Postal code: 1231LC
Country: Netherlands 🇳🇱
E-mail: sanne@commonsenseclinical.nl 📧
Internet address: http://www.commonsenseclinical.nl 🌏
Total value of the procurement: 400 000 EUR 💰
Name: DF/Net Research, Inc.
National registration number: 200852149
Postal address: 140 Lakeside Ave., Suite 310
Postal town: Seattle
Postal code: 98122
Phone: +1 2064467949 📞
E-mail: kevin@dfnetresearch.com 📧
Internet address: http://www.dfnetresearch.com 🌏
Name: StatisticaMedica Ltd
National registration number: 9670232P
Postal address: 26 Belarmine Court
Postal town: Stepaside
Postal code: D18 TD82
Phone: +353 868598777 📞
E-mail: gloria.crispino@statisticamedica.com 📧
Country: Dublin 🏙️
Name: Rede Optimus Hospitalar AG
National registration number: CHE-216.455.548 MWST
Postal address: Fröbelstrasse 10
Postal town: Zürich
Postal code: 8032
Country: Switzerland 🇨🇭
E-mail: marc.bosiers@telenet.be 📧
Internet address: http://www.rdeoptimus.com.br 🌏
Information about tenders
Number of tenders received: 10

Contracting authority
Contact
Contact point: Máire Hornibrook
Source: OJS 2021/S 225-592419 (2021-11-16)
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Region:
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Suppliers:
Afortiori Development Common Sense Clinical DF/Net Research, Inc. MCRA LLC Rede Optimus Hospitalar AG StatisticaMedica Ltd TRIUM Clinical Consulting NV
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