1.1 Buyer
Official name
:
European Medicines Agency
Data Management Services
Dienstleistungen im Bereich Datenmanagement in verschiedenen administrativen Bereichen der Human- und Veterinärdaten, im Bereich der Datenüberprüfung und -validierung, der Wartung, der Reinigung und der Aktivitäten des Qualitätsmanagements. Sopimuksen kohteena ovat tiedonhallintapalvelut useilla hallinnollisilla ihmis- ja eläinlääketiedettä koskevilla aloilla ja tietojen arvioinnin ja validoinnin alalla sekä ylläpitoa, puhdistusta ja laadunhallintaa koskevat …
CPV: 72322000 Servicios de gestión de datos
1. Buyer
2. Procedure
2.1 Procedure
Title
:
Data Management Services
Description
:
Data management services in various administrative human and veterinary data domains, in the domain of data review and validation, maintenance, cleansing and quality management activities.
Procedure identifier
:
21fca07b-f7bd-4092-a21e-3569b67c9117
Internal identifier
:
EMA/2019/15/BD
2.1.1 Purpose
Main classification
(
cpv
):
72322000
Data management services
2.1.4 General information
Legal basis
:
Regulation (EU, Euratom) 2018/1046
not applicable
-
not applicable
5. Lot
5.1 Lot technical ID : LOT-0000
Title
:
Data Management Services
Description
:
The tender aims to put into place contractual arrangements that will enable the EMA to acquire services provided by outsourced resources. These resources will contribute expertise directly to the data management activities of various programmes, including but not limited to: • EudraVigilance — the Agency’s pharmacovigilance system for xEVMPD and ICSR data; • SPOR — centralised IDMP master data management system for organisation, location and substance data; • Parallel distribution — the Agency’s database for notices of distribution of CAPs from one EU member state to another. The tasks include data review, validation, maintenance and cleansing tasks, including quality management.
Internal identifier
:
EMA/2019/15/BD
5.1.1 Purpose
Main nature of the contract
:
Services
Main classification
(
cpv
):
72322000
Data management services
5.1.6 General information
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA)
:
no
5.1.16 Further information, mediation and review
Review organisation
:
General Court Luxembourg
Organisation providing more information on the review procedures
:
General Court Luxembourg
TED eSender
:
Publications Office of the European Union
6. Results
Maximum value of the framework agreements in this procedure
:
18 000 000
Euro
6.1 Result lot ldentifier : LOT-0000
6.1.2 Information about winners
Winner
:
Official name
:
Syneos Health Netherlands B.V.
Tender
:
Tender identifier
:
Syneos Health Netherlands B.V.
Identifier of lot or group of lots
:
LOT-0000
Value of the tender
:
18 000 000
Euro
The tender was ranked
:
yes
Rank in the list of winners
:
1
Subcontracting
:
No
Contract information
:
Identifier of the contract
:
EMA/2019/15/BD/1
Title
:
Data Management Services — first priority
Date of the conclusion of the contract
:
11/01/2021
Winner
:
Official name
:
NTT Data Belgique (formerly Everis Belgique SPRL)
Tender
:
Tender identifier
:
NTT DATA Belgique SRL
Identifier of lot or group of lots
:
LOT-0000
Value of the tender
:
18 000 000
Euro
The tender was ranked
:
yes
Rank in the list of winners
:
2
Subcontracting
:
No
Contract information
:
Identifier of the contract
:
EMA/2019/15/BD/2
Title
:
Data Management Services — second Priority
Date of the conclusion of the contract
:
08/01/2021
7. Modification
7.1 Modification
Identifier of the previous contract award notice
:
26520-2021
Identifier of the modified contract
:
CON-0001
Reason for modification
:
Need for additional works, services or supplies by the original contractor.
Description
:
Increase of the ceiling with 50% up to 18,000,000.00 EUR.
7.1.1 Change
Description of modifications
:
Increase of the ceiling with 50% up to 18,000,000.00 EUR.
Business entity identifier in the previous notice
:
ORG-0002
7.1 Modification
Identifier of the previous contract award notice
:
26520-2021
Identifier of the modified contract
:
CON-0002
Reason for modification
:
Need for additional works, services or supplies by the original contractor.
Description
:
Increase of the ceiling with 50% up to 18,000,000.00 EUR.
7.1.1 Change
Description of modifications
:
Increase of the ceiling with 50% up to 18,000,000.00 EUR.
Business entity identifier in the previous notice
:
ORG-0003
8. Organisations
8.1 ORG-0001
Official name
:
European Medicines Agency
Registration number
:
not applicable
Postal address
:
PO Box 71010
Town
:
Amsterdam
Postcode
:
1008 BA
Country subdivision (NUTS)
:
Groot-Amsterdam
(
NL329
)
Country
:
Netherlands
Telephone
:
088 781 6000
Roles of this organisation
:
Buyer
8.1 ORG-0002
Official name
:
Syneos Health Netherlands B.V.
Registration number
:
30162108
Town
:
Amsterdam
Postcode
:
1101HE
Country subdivision (NUTS)
:
Groot-Amsterdam
(
NL329
)
Country
:
Netherlands
Roles of this organisation
:
Tenderer
Winner of these lots
:
LOT-0000
8.1 ORG-0003
Official name
:
NTT Data Belgique (formerly Everis Belgique SPRL)
Registration number
:
712941486
Town
:
Brussels
Postcode
:
1000
Country subdivision (NUTS)
:
Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
(
BE100
)
Country
:
Belgium
Roles of this organisation
:
Tenderer
Winner of these lots
:
LOT-0000
8.1 ORG-0004
Official name
:
General Court Luxembourg
Registration number
:
N/A
Postal address
:
rue du Fort Niedergrünewald
Town
:
Luxembourg
Postcode
:
2925
Country subdivision (NUTS)
:
Luxembourg
(
LU000
)
Country
:
Luxembourg
Telephone
:
+352 4303-1
Fax
:
+352 4303-2100
Roles of this organisation
:
Review organisation
Organisation providing more information on the review procedures
8.1 ORG-0000
Official name
:
Publications Office of the European Union
Registration number
:
PUBL
Town
:
Luxembourg
Postcode
:
2417
Country subdivision (NUTS)
:
Luxembourg
(
LU000
)
Country
:
Luxembourg
Telephone
:
+352 29291
Roles of this organisation
:
TED eSender
11. Notice information
11.1 Notice information
Notice identifier/version
:
0d6424f9-4e3f-473f-bcb6-63a76c3a75b8
-
01
Form type
:
Contract modification
Notice type
:
Contract modification notice
Notice dispatch date
:
13/12/2024
14:08 +00:00
Languages in which this notice is officially available
:
English
Danish, German, Spanish, Finnish, French, Greek, Italian, Dutch, Portuguese, Swedish, Czech, Estonian, Hungarian, Lithuanian, Latvian, Maltese, Polish, Slovak, Slovenian, Irish, Bulgarian, Romanian, Croatian
11.2 Publication information
Notice publication number
:
00772159-2024
OJ S issue number
:
245/2024
Publication date
:
17/12/2024