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)
Contracting authority
Name and addresses
Name: National University of Ireland, Galway (NUI Galway)
National registration number: N/a
Postal address: University Road
Postal town: Galway
Country: Ireland 🇮🇪
Contact person: Frances Feeney
Phone: +353 91524411 📞
E-mail: frances.feeney@nuigalway.ie 📧
Region: West 🏙️
URL: http://www.nuigalway.ie 🌏
Address of the buyer profile: https://irl.eu-supply.com/ctm/Company/CompanyInformation/Index/414 🌏
Communication
Documents URL: http://irl.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=185563&B=ETENDERS_SIMPLE 🌏
Participation URL: http://irl.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=185563&B=ETENDERS_SIMPLE 🌏

Object
Scope of the procurement
Title: Clinical Research Services in Ten Lots NUIG/CON1218/2020
Products/services: Research services 📦
Short description:
“Lot 1A: Clinical research full service — device trials (full service including financial invoicing); Lot 1B: Clinical research full service — pharma trials...”    Show more
Estimated value excluding VAT: EUR 2 800 000 💰
Information about lots
Tenders may be submitted for all lots

1️⃣
Scope of the procurement
Title:
“Lot 1A: Clinical Research Full Service — Device Trials (Full Service Including Financial Invoicing)”
Title
Lot Identification Number: 1A
Description
Additional products/services: Research and development services and related consultancy services 📦
Additional products/services: Research and experimental development services 📦
Additional products/services: Research laboratory services 📦
Additional products/services: Research and development consultancy services 📦
Additional products/services: Research consultancy services 📦
Additional products/services: Translation services 📦
Place of performance: West 🏙️
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...”    Show more
Award criteria
Price is not the only award criterion and all criteria are stated only in the procurement documents
Duration of the contract, framework agreement or dynamic purchasing system
The time frame below is expressed in number of months.
Description
Duration: 24
Duration of the contract, framework agreement or dynamic purchasing system
This contract is subject to renewal
Description
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...”    Show more

2️⃣
Scope of the procurement
Title:
“Lot 1B: Clinical Research Full Service — Pharma Trials (Full Service Including Financial Invoicing)”
Title
Lot Identification Number: 1B
Description
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...”    Show more

3️⃣
Scope of the procurement
Title:
“Lot 2: Clinical Research Services: Quality and Regulatory services for Clinical Trials”
Title
Lot Identification Number: 2
Description
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...”    Show more

4️⃣
Scope of the procurement
Title:
“Lot 3: Clinical Research Services: Biostatistics and Clinical Study Design Services for Clinical Trials”
Title
Lot Identification Number: 3
Description
Description of the procurement:
“Operational and strategic biostatistical support for clinical research activities. Including Protocol design support and statistical analysis plan support...”    Show more

5️⃣
Scope of the procurement
Title:
“Lot 4: Clinical Research Services: Study Co-ordination and Management services for Clinical Trials”
Title
Lot Identification Number: 4
Description
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...”    Show more

6️⃣
Scope of the procurement
Title:
“Lot 5A: Clinical Research Safety Services — Clinical Trial Device Vigilance/Safety Services”
Title
Lot Identification Number: 5A
Description
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...”    Show more

7️⃣
Scope of the procurement
Title:
“Lot 5B: Clinical Research Safety Services — Clinical Trial Pharmacovigilance/Safety Services”
Title
Lot Identification Number: 5B
Description
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...”    Show more

8️⃣
Scope of the procurement
Title:
“Lot 6: Clinical Research Services: Clinical Database Programming and Data Management Services”
Title
Lot Identification Number: 6
Description
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...”    Show more

9️⃣
Scope of the procurement
Title:
“Lot 7: Clinical Research Services: Validation and Compliance services for Clinical Trials”
Title
Lot Identification Number: 7
Description
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...”    Show more

1️⃣0️⃣
Scope of the procurement
Title: Lot 8: Clinical Research Services: Medical Writing and Translation Services
Title
Lot Identification Number: 8
Description
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...”    Show more

Legal, economic, financial and technical information
Economic and financial standing
Selection criteria as stated in the procurement documents
Technical and professional ability
Selection criteria as stated in the procurement documents
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

Procedure
Type of procedure
Open procedure
Information about a framework agreement or a dynamic purchasing system
Framework agreement with several operators
Description
Envisaged maximum number of participants to the framework agreement: 48
Administrative information
Time limit for receipt of tenders or requests to participate: 2021-04-26 14:00 📅
Languages in which tenders or requests to participate may be submitted: English 🗣️
The time frame below is expressed in number of months.
Minimum time frame during which the tenderer must maintain the tender: 12
Conditions for opening of tenders: 2021-04-26 14:00 📅

Complementary information
Information about recurrence
This is a recurrent procurement
Estimated timing for further notices to be published: 26 September 2024.
Information about electronic workflows
Electronic ordering will be used
Electronic invoicing will be accepted
Electronic payment will be used
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
Title: Clinical Research Services in 10 Lots 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...”    Show more

Complementary information
Original notice reference
Notice number in the OJ S: 2021/S 063-160281

Changes
Other additional information

“The deadline for Tender Responses has been extended to Tuesday 4 May 2021 at 10 a.m. Irish time.”
Source: OJS 2021/S 081-209529 (2021-04-22)
Contract award notice (2021-11-16)
Contracting authority
Name and addresses
Postal code: Galway
Contact person: Máire Hornibrook
E-mail: maire.hornibrook@nuigalway.ie 📧

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...”    Show more
Total value of the procurement (excluding VAT): EUR 2 800 000 💰
Information about lots
This contract is divided into lots
Scope of the procurement
Title:
“Lot 1A: Clinical Research Full Service - Device Trials (Full Service including financial invoicing)”
Description
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...”    Show more
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
Scope of the procurement
Title:
“Lot 1B: Clinical Research Full Service - Pharma Trials (Full Service including financial invoicing)”
Description
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...”    Show more
Scope of the procurement
Title:
“Lot 3: Clinical Research Services: Biostatistics and Clinical Study Design services for Clinical Tri”
Description
Description of the procurement:
“Operational and strategic biostatistical support for Clinical research activities. Including Protocol design support and statistical analysis plan support...”    Show more
Scope of the procurement
Title:
“Lot 4: Clinical Research Services: Study Co-ordination & Management services for Clinical Trials”
Title:
“Lot 5A : Clinical Research Safety Services - Clinical Trial Device vigilance/safety services”
Title:
“Lot 5B : Clinical Research Safety Services - Clinical Trial Pharmacovigilance/safety services”
Description
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...”    Show more
Scope of the procurement
Title:
“Lot 6: Clinical Research Services: Clinical Database programming and data management services”
Description
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...”    Show more
Scope of the procurement
Title:
“Lot 7: Clinical Research Services: Validation and Compliance services for clinical trials”
Description
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...”    Show more
Scope of the procurement
Title: Lot 8: Clinical Research Services: Medical writing and Translation services
Description
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...”    Show more
Award criteria
Quality criterion (name): Understanding of Brief and Proposed Methdology

Procedure
Information about framework agreement
The procurement involves the establishment of a framework agreement
Administrative information
Previous publication concerning this procedure: 2021/S 063-160281

Award of contract

1️⃣
Contract Number: 1
Lot Identification Number: 1
Title:
“Lot 1A: Clinical Research Full Service - Device Trials (Full Service including financial invoicing)”
Date of conclusion of the contract: 2021-11-15 📅
Information about tenders
Number of tenders received: 10
Number of tenders received by electronic means: 10
Name and address of the contractor
Name: Afortiori Development
National registration number: E3430005NH
Postal address: Portershed
Postal town: Galway
Postal code: Galway
Country: Ireland 🇮🇪
E-mail: nicola@aftdev.com 📧
Region: West 🏙️
URL: http://www.aftdev.com 🌏
The contractor is an SME
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 200 000 💰

2️⃣
Contract Number: 2
Name and address of the contractor
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 📧
Region: us 🏙️
The contractor is an SME
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 200 000 💰

3️⃣
Contract Number: 3
Name and address of the contractor
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 📧
Region: Belgique/België 🏙️
URL: http://www.triumclinicalconsulting.com 🌏
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 200 000 💰

4️⃣
Contract Number: 4
Lot Identification Number: 2
Title:
“Lot 1B: Clinical Research Full Service - Pharma Trials (Full Service including financial invoicing)”
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 200 000 💰

5️⃣
Contract Number: 5
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 200 000 💰

6️⃣
Contract Number: 6
Lot Identification Number: 3
Title:
“Lot 2: Clinical Research Services: Quality and Regulatory services for Clinical Trials”
Name and address of the contractor
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 📧
Region: Nederland 🏙️
URL: http://www.commonsenseclinical.nl 🌏
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

7️⃣
Contract Number: 7
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

8️⃣
Contract Number: 8
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

9️⃣
Contract Number: 9
Lot Identification Number: 4
Title:
“Lot 3: Clinical Research Services: Biostatistics and Clinical Study Design services for Clinical Tri”
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

1️⃣0️⃣
Contract Number: 10
Name and address of the contractor
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 📧
URL: http://www.dfnetresearch.com 🌏
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

1️⃣1️⃣
Contract Number: 11
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

1️⃣2️⃣
Contract Number: 12
Name and address of the contractor
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 📧
Region: Dublin 🏙️
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

1️⃣3️⃣
Contract Number: 13
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

1️⃣4️⃣
Contract Number: 14
Lot Identification Number: 5
Title:
“Lot 4: Clinical Research Services: Study Co-ordination & Management services for Clinical Trials”
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

1️⃣5️⃣
Contract Number: 15
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

1️⃣6️⃣
Contract Number: 16
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

1️⃣7️⃣
Contract Number: 17
Name and address of the contractor
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 📧
Region: Schweiz/Suisse/Svizzera 🏙️
URL: http://www.rdeoptimus.com.br 🌏
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

1️⃣8️⃣
Contract Number: 18
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

1️⃣9️⃣
Contract Number: 19
Lot Identification Number: 6
Title:
“Lot 5A : Clinical Research Safety Services - Clinical Trial Device vigilance/safety services”
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

2️⃣0️⃣
Contract Number: 20
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

2️⃣1️⃣
Contract Number: 21
Title:
“Lot 5B : Clinical Research Safety Services - Clinical Trial Pharmacovigilance/safety services”
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

2️⃣2️⃣
Contract Number: 22
Lot Identification Number: 8
Title:
“Lot 6: Clinical Research Services: Clinical Database programming and data management services”
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

2️⃣3️⃣
Contract Number: 23
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

2️⃣4️⃣
Contract Number: 24
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

2️⃣5️⃣
Contract Number: 25
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

2️⃣6️⃣
Contract Number: 26
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

2️⃣7️⃣
Contract Number: 27
Title:
“Lot 7: Clinical Research Services: Validation and Compliance services for clinical trials”
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰

2️⃣8️⃣
Contract Number: 28
Title: Lot 8: Clinical Research Services: Medical writing and Translation services
Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: EUR 400 000 💰
Source: OJS 2021/S 225-592419 (2021-11-16)