Establishment of a Single Operator Framework Agreement for an Electronic Trial Master File (eTMF) and Associated Services (GALW/CON1646/2023)

The Clinical Trials Institute is looking to procure an electronic trial master file (eTMF) system and services for documentation and management of our clinical trials. The Clinical Trials Institute is looking to procure an electronic trial master file (eTMF) system and services for documentation and management of our clinical trials.

CPV: 48170000 Pakiety oprogramowania zapewniające zgodność, 48311000 Pakiety oprogramowania do zarządzania dokumentami, 48331000 Pakiety oprogramowania do zarządzania projektami, 73000000 Usługi badawcze i eksperymentalno-rozwojowe oraz pokrewne usługi doradcze, 73110000 Usługi badawcze
Miejsce wykonania:
Establishment of a Single Operator Framework Agreement for an Electronic Trial Master File (eTMF) and Associated Services (GALW/CON1646/2023)
Miejsce udzielenia zamówienia:
University of Galway (ID 1400)
Numer nagrody:
CON1646

1. Buyer

1.1 Buyer

Official name : University of Galway (ID 1400)
Legal type of the buyer : Body governed by public law
Activity of the contracting authority : Education

2. Procedure

2.1 Procedure

Title : Establishment of a Single Operator Framework Agreement for an Electronic Trial Master File (eTMF) and Associated Services (GALW/CON1646/2023)
Description : The Clinical Trials Institute is looking to procure an electronic trial master file (eTMF) system and services for documentation and management of our clinical trials.
Procedure identifier : cde326e1-bf98-451f-a039-55c1ccac20df
Previous notice : 3fe4e711-3a51-4e83-8758-10076cb7fc94-01
Type of procedure : Open
The procedure is accelerated : no
Justification for the accelerated procedure :
Main features of the procedure :

2.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 48331000 Project management software package
Additional classification ( cpv ): 48311000 Document management software package
Additional classification ( cpv ): 48170000 Compliance software package
Additional classification ( cpv ): 73110000 Research services
Additional classification ( cpv ): 73000000 Research and development services and related consultancy services

2.1.2 Place of performance

Country : Ireland
Anywhere in the given country

2.1.3 Value

Maximum value of the framework agreement : 800 000 Euro

2.1.4 General information

Legal basis :
Directive 2014/24/EU

5. Lot

5.1 Lot technical ID : LOT-0001

Title : Establishment of a Single Operator Framework Agreement for an Electronic Trial Master File (eTMF) and Associated Services (GALW/CON1646/2023)
Description : The Clinical Trials Institute is looking to procure an electronic trial master file (eTMF) system and services for documentation and management of our clinical trials.
Internal identifier : 0

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 48331000 Project management software package
Additional classification ( cpv ): 48311000 Document management software package
Additional classification ( cpv ): 48170000 Compliance software package
Additional classification ( cpv ): 73110000 Research services
Additional classification ( cpv ): 73000000 Research and development services and related consultancy services

5.1.2 Place of performance

Country : Ireland
Anywhere in the given country
Additional information :

5.1.5 Value

Estimated value excluding VAT : 800 000 Euro

5.1.6 General information

Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.7 Strategic procurement

Aim of strategic procurement : No strategic procurement

5.1.10 Award criteria

Criterion :
Type : Cost
Name :
Description : cost @ 40%
Weight (percentage, exact) : 40
Criterion :
Type : Quality
Name :
Description : quality @ 60%
Weight (percentage, exact) : 60
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.12 Terms of procurement

Information about review deadlines : none

5.1.15 Techniques

Framework agreement :
Framework agreement, without reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : The High Court of Ireland
Organisation providing offline access to the procurement documents : University of Galway (ID 1400)
TED eSender : European Dynamics S.A.

6. Results

Maximum value of the framework agreements in this procedure : 800 000 Euro

6.1 Result lot ldentifier : LOT-0001

At least one winner was chosen.
Framework agreement :
Maximum value of the framework agreement : 800 000 Euro

6.1.2 Information about winners

Winner :
Official name : Cloud9 Software BV
Tender :
Tender identifier : 000039864
Identifier of lot or group of lots : LOT-0001
Subcontracting : No
Contract information :
Identifier of the contract : 415464
Date on which the winner was chosen : 07/05/2024
Date of the conclusion of the contract : 08/05/2024
The contract is awarded within a framework agreement : no

6.1.4 Statistical information

Received tenders or requests to participate :
Type of received submissions : Tenders submitted electronically
Number of tenders or requests to participate received : 2

8. Organisations

8.1 ORG-0001

Official name : University of Galway (ID 1400)
Registration number : 0022578J
Postal address : University Road, Galway
Town : Galway
Postcode : H91TK33
Country subdivision (NUTS) : Dublin ( IE061 )
Country : Ireland
Telephone : 091493970
Roles of this organisation :
Buyer
Organisation providing offline access to the procurement documents

8.1 ORG-0002

Official name : Cloud9 Software BV
Registration number : 57141622
Postal address : Striksteeg 7
Town : Deventer
Postcode : 7411 KR
Country subdivision (NUTS) : Groot-Amsterdam ( NL329 )
Country : Netherlands
Telephone : 31 570 594 789
Roles of this organisation :
Tenderer
Winner of these lots : LOT-0001

8.1 ORG-0003

Official name : The High Court of Ireland
Registration number : The High Court of Ireland
Department : The High Court of Ireland
Postal address : Four Courts, Inns Quay, Dublin 7
Town : Dublin
Postcode : D07 WDX8
Country subdivision (NUTS) : Dublin ( IE061 )
Country : Ireland
Telephone : +353 1 8886000
Roles of this organisation :
Review organisation

8.1 ORG-0004

Official name : European Dynamics S.A.
Registration number : 002024901000
Department : European Dynamics S.A.
Town : Athens
Postcode : 15125
Country subdivision (NUTS) : Βόρειος Τομέας Αθηνών ( EL301 )
Country : Greece
Telephone : +30 2108094500
Roles of this organisation :
TED eSender

11. Notice information

11.1 Notice information

Notice identifier/version : a5dea3b6-7bd8-48e2-bbf1-186e12cf5991 - 01
Form type : Result
Notice type : Contract or concession award notice – standard regime
Notice dispatch date : 22/01/2025 10:21 +00:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00049771-2025
OJ S issue number : 16/2025
Publication date : 23/01/2025