Services - 449719-2018

16/10/2018    S199    Agencies - Services - Contract award notice - Open procedure 

United Kingdom-London: Efficacy and Safety Studies on Medicines

2018/S 199-449719

Contract award notice

Results of the procurement procedure

Services

Legal Basis:

Directive 2014/24/EU

Section I: Contracting authority

I.1)Name and addresses
I.2)Information about joint procurement
I.4)Type of the contracting authority
European institution/agency or international organisation
I.5)Main activity
Health

Section II: Object

II.1)Scope of the procurement
II.1.1)Title:

Efficacy and Safety Studies on Medicines

Reference number: EMA/2017/09/PE
II.1.2)Main CPV code
73000000
II.1.3)Type of contract
Services
II.1.4)Short description:

Post-authorisation effectiveness and pharmacoepidemiology studies to generate data and information to support regulatory decision-making. Research may also focus on the effectiveness of regulatory measures taken and on the impact of relevant legislation. The range of research topics is limited to those with high public health relevance and with a European impact. The scope of the funding covers both nationally and centrally authorised products, including vaccines. The results obtained from this research will subsequently be assessed by the responsible Agency Committee regarding the need for regulatory action and further research may subsequently also be conducted to measure the effectiveness of regulatory actions taken.

The research may concern four different lots, with a maximum of 5 framework contracts for lots 1, 2 and 3 and a maximum of 8 framework contracts for lot 4.

II.1.6)Information about lots
This contract is divided into lots: yes
II.1.7)Total value of the procurement (excluding VAT)
Value excluding VAT: 5 000 000.00 EUR
II.2)Description
II.2.1)Title:

Use of Innovative Methods to Optimise the Utility of Sparse Data to Support Benefit/Risk Assessment

Lot No: 1
II.2.2)Additional CPV code(s)
73210000
II.2.3)Place of performance
NUTS code: UKI4
II.2.4)Description of the procurement:

For full description please see section 3.2 of the technical specifications (procurement documents).

II.2.5)Award criteria
Quality criterion - Name: Case study / Weighting: 30
Quality criterion - Name: Research Team and Tasks / Weighting: 20
Quality criterion - Name: Project management and communication / Weighting: 20
Price - Weighting: 30
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.2.14)Additional information

Please note that a maximum of 5 framework contracts is foreseen for lot 1.

II.2)Description
II.2.1)Title:

Qualitative research

Lot No: 2
II.2.2)Additional CPV code(s)
73210000
II.2.3)Place of performance
NUTS code: UKI4
II.2.4)Description of the procurement:

For full description please see section 3.2 of the technical specifications (procurement documents).

II.2.5)Award criteria
Quality criterion - Name: Case study / Weighting: 30
Quality criterion - Name: Research Team and Tasks / Weighting: 20
Quality criterion - Name: Project management and communication / Weighting: 20
Price - Weighting: 30
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.2.14)Additional information

Please note that a maximum of 5 framework contracts is foreseen for lot 2.

II.2)Description
II.2.1)Title:

Pharmacoepidemiology Research — Rapid Descriptive Studies

Lot No: 3
II.2.2)Additional CPV code(s)
73210000
II.2.3)Place of performance
NUTS code: UKI4
II.2.4)Description of the procurement:

For full description please see section 3.2 of the technical specifications (procurement documents).

II.2.5)Award criteria
Quality criterion - Name: Case study / Weighting: 30
Quality criterion - Name: Research Team and Tasks / Weighting: 20
Quality criterion - Name: Project management and communication / Weighting: 20
Price - Weighting: 30
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.2.14)Additional information

Please note that a maximum of 5 framework contracts is foreseen for lot 3.

II.2)Description
II.2.1)Title:

Pharmacoepidemiology Research — Association Studies, Including Pregnancy and Breastfeeding Research

Lot No: 4
II.2.2)Additional CPV code(s)
73210000
II.2.3)Place of performance
NUTS code: UKI4
II.2.4)Description of the procurement:

For full description please see section 3.2 of the technical specifications (procurement documents).

II.2.5)Award criteria
Quality criterion - Name: Case study / Weighting: 30
Quality criterion - Name: Research Team and Tasks / Weighting: 20
Quality criterion - Name: Project management and communication / Weighting: 20
Price - Weighting: 30
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.2.14)Additional information

Please note that a maximum of 8 framework contracts is foreseen for lot 4.

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
IV.1.6)Information about electronic auction
IV.1.8)Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: no
IV.2)Administrative information
IV.2.1)Previous publication concerning this procedure
Notice number in the OJ S: 2017/S 240-497343
IV.2.8)Information about termination of dynamic purchasing system
IV.2.9)Information about termination of call for competition in the form of a prior information notice

Section V: Award of contract

Contract No: EMA/2018/17/PE
Lot No: 1
Title:

Use of Innovative Methods to Optimise the Utility of Sparse Data to Support Benefit/Risk Assessment

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
06/09/2018
V.2.2)Information about tenders
Number of tenders received: 3
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
University of Dundee
Dundee
United Kingdom
NUTS code: UKM71
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Initial estimated total value of the contract/lot: 400 000.00 EUR
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: EMA/2018/19/PE
Lot No: 2
Title:

Qualitative Research

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
06/09/2018
V.2.2)Information about tenders
Number of tenders received: 6
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
IQVIA
Reading
United Kingdom
NUTS code: UKJ11
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Initial estimated total value of the contract/lot: 600 000.00 EUR
Total value of the contract/lot: 600 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: EMA/2018/20/PE
Lot No: 2
Title:

Qualitative Research

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
06/09/2018
V.2.2)Information about tenders
Number of tenders received: 6
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Icon Clinical Research Ltd
Dublin
Ireland
NUTS code: IE061
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Initial estimated total value of the contract/lot: 600 000.00 EUR
Total value of the contract/lot: 600 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: EMA/2018/21/PE
Lot No: 3
Title:

Pharmacoepidemiology Research — Rapid Descriptive Studies

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
06/09/2018
V.2.2)Information about tenders
Number of tenders received: 8
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Erasmus University Medical Center
Rotterdam
Netherlands
NUTS code: NL4
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Initial estimated total value of the contract/lot: 1 000 000.00 EUR
Total value of the contract/lot: 1 000 000.00 EUR
V.2.5)Information about subcontracting
The contract is likely to be subcontracted
Short description of the part of the contract to be subcontracted:

Not known.

Section V: Award of contract

Contract No: EMA/2018/22/PE
Lot No: 3
Title:

Pharmacoepidemiology Research — Rapid Descriptive Studies

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
06/09/2018
V.2.2)Information about tenders
Number of tenders received: 8
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
IQVIA
Reading
United Kingdom
NUTS code: UKJ11
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Initial estimated total value of the contract/lot: 1 000 000.00 EUR
Total value of the contract/lot: 1 000 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: EMA/2018/24/PE
Lot No: 4
Title:

Pharmacoepidemiology Research — Association Studies, Including Pregnancy and Breastfeeding

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
06/09/2018
V.2.2)Information about tenders
Number of tenders received: 8
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
Aarhus University Hospital, Department of Clinical Epidemiology
Aarhus
Denmark
NUTS code: DK
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Initial estimated total value of the contract/lot: 3 000 000.00 EUR
Total value of the contract/lot: 3 000 000.00 EUR
V.2.5)Information about subcontracting
The contract is likely to be subcontracted
Short description of the part of the contract to be subcontracted:

Not known.

Section V: Award of contract

Contract No: EMA/2018/25/PE
Lot No: 4
Title:

Pharmacoepidemiology Research — Association Studies, Including Pregnancy and Breastfeeding

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
06/09/2018
V.2.2)Information about tenders
Number of tenders received: 8
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
University of Dundee
Dundee
United Kingdom
NUTS code: UKM71
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Initial estimated total value of the contract/lot: 3 000 000.00 EUR
Total value of the contract/lot: 3 000 000.00 EUR
V.2.5)Information about subcontracting
The contract is likely to be subcontracted
Short description of the part of the contract to be subcontracted:

Not known.

Section V: Award of contract

Contract No: EMA/2018/26/PE
Lot No: 4
Title:

Pharmacoepidemiology Research — Association Studies, Including Pregnancy and Breastfeeding

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
06/09/2018
V.2.2)Information about tenders
Number of tenders received: 8
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
RTI Health Solutions
Barcelona
Spain
NUTS code: ES511
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Initial estimated total value of the contract/lot: 3 000 000.00 EUR
Total value of the contract/lot: 3 000 000.00 EUR
V.2.5)Information about subcontracting
The contract is likely to be subcontracted
Short description of the part of the contract to be subcontracted:

Not known.

Section V: Award of contract

Contract No: EMA/2018/29/PE
Lot No: 4
Title:

Pharmacoepidemiology Research — Association Studies, Including Pregnancy and Breastfeeding

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
06/09/2018
V.2.2)Information about tenders
Number of tenders received: 8
The contract has been awarded to a group of economic operators: no
V.2.3)Name and address of the contractor
IQVIA
Readining
United Kingdom
NUTS code: UKJ11
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Initial estimated total value of the contract/lot: 3 000 000.00 EUR
Total value of the contract/lot: 3 000 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: EMA/2018/16/PE
Lot No: 1
Title:

Use of Innovative Methods to Optimize the Utility of Sparse Data to Support Benefit/Risk Assessment

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
20/09/2018
V.2.2)Information about tenders
Number of tenders received: 3
The contract has been awarded to a group of economic operators: yes
V.2.3)Name and address of the contractor
Hasselt University
Hasselt
Belgium
NUTS code: BE221
The contractor is an SME: no
V.2.3)Name and address of the contractor
Katholieke Universiteit Leuven
Leuven
Belgium
NUTS code: BE242
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 400 000.00 EUR
V.2.5)Information about subcontracting

Section V: Award of contract

Contract No: EMA/2018/18/PE
Lot No: 2
Title:

Qualitative Research

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
03/10/2018
V.2.2)Information about tenders
Number of tenders received: 6
The contract has been awarded to a group of economic operators: yes
V.2.3)Name and address of the contractor
Universiteit Utrecht
Utrecht
Netherlands
NUTS code: NL310
The contractor is an SME: no
V.2.3)Name and address of the contractor
University Medical Center Utrecht
Utrecht
Netherlands
NUTS code: NL310
The contractor is an SME: no
V.2.3)Name and address of the contractor
Dpt. Biomedical, Dental Sciences, Morphofunctional Imaging (BIOMORF) University Messina
Messina
Italy
NUTS code: ITG13
The contractor is an SME: no
V.2.3)Name and address of the contractor
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
Madrid
Spain
NUTS code: ES300
The contractor is an SME: no
V.2.3)Name and address of the contractor
Fundació Institut Català de Farmacologia (FICF)
Barcelona
Spain
NUTS code: ES511
The contractor is an SME: no
V.2.3)Name and address of the contractor
London School of Hygiene and Tropical Medicine (LSHTM)
London
United Kingdom
NUTS code: UKI3
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 600 000.00 EUR
V.2.5)Information about subcontracting
The contract is likely to be subcontracted
Short description of the part of the contract to be subcontracted:

Not known

Section V: Award of contract

Contract No: EMA/2018/23/PE
Lot No: 3
Title:

Pharmacoepidemiology Research — Rapid Descriptive Studies

A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
03/10/2018
V.2.2)Information about tenders
Number of tenders received: 8
The contract has been awarded to a group of economic operators: yes
V.2.3)Name and address of the contractor
Universiteit Utrecht
Utrecht
Netherlands
NUTS code: NL310
The contractor is an SME: no
V.2.3)Name and address of the contractor
University Medical Center Utrecht
Utrecht
Netherlands
NUTS code: NL310
The contractor is an SME: no
V.2.3)Name and address of the contractor
Dpt. Biomedical, Dental Sciences, Morphofunctional Imaging (BIOMORF) University Messina
Messina
Italy
NUTS code: ITG13
The contractor is an SME: no
V.2.3)Name and address of the contractor
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
Madrid
Spain
NUTS code: ES300
The contractor is an SME: no
V.2.3)Name and address of the contractor
Fundació Institut Català de Farmacologia (FICF)
Barcelona
Spain
NUTS code: ES511
The contractor is an SME: no
V.2.3)Name and address of the contractor
London School of Hygiene and Tropical Medicine (LSHTM)
London
United Kingdom
NUTS code: UKI3
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 1 000 000.00 EUR
V.2.5)Information about subcontracting
The contract is likely to be subcontracted
Short description of the part of the contract to be subcontracted:

Not known.

Section V: Award of contract

Contract No: EMA/2018/28/PE
Lot No: Lot 4
A contract/lot is awarded: yes
V.2)Award of contract
V.2.1)Date of conclusion of the contract:
03/10/2018
V.2.2)Information about tenders
Number of tenders received: 8
The contract has been awarded to a group of economic operators: yes
V.2.3)Name and address of the contractor
Universiteit Utrecht
Utrecht
Netherlands
NUTS code: NL310
The contractor is an SME: no
V.2.3)Name and address of the contractor
University Medical Center Utrecht
Utrecht
Netherlands
NUTS code: NL310
The contractor is an SME: no
V.2.3)Name and address of the contractor
Dpt. Biomedical, Dental Sciences, Morphofunctional Imaging (BIOMORF) University Messina
Utrecht
Netherlands
NUTS code: NL310
The contractor is an SME: no
V.2.3)Name and address of the contractor
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
Madrid
Spain
NUTS code: ES300
The contractor is an SME: no
V.2.3)Name and address of the contractor
Fundació Institut Català de Farmacologia (FICF)
Barcelona
Spain
NUTS code: ES511
The contractor is an SME: no
V.2.3)Name and address of the contractor
London School of Hygiene and Tropical Medicine (LSHTM)
London
United Kingdom
NUTS code: UKI3
The contractor is an SME: no
V.2.4)Information on value of the contract/lot (excluding VAT)
Total value of the contract/lot: 3 000 000.00 EUR
V.2.5)Information about subcontracting
The contract is likely to be subcontracted
Short description of the part of the contract to be subcontracted:

Not known

Section VI: Complementary information

VI.3)Additional information:

Please note only 1 tender per tenderer per lot may be submitted.

VI.4)Procedures for review
VI.4.1)Review body
General Court
rue du Fort Niedergrünewald
Luxembourg
2925
Luxembourg
Telephone: +352 4303-1
E-mail: generalcourt.registry@curia.europa.eu
Fax: +352 4303-2100

Internet address: http://curia.europa.eu

VI.4.2)Body responsible for mediation procedures
VI.4.3)Review procedure
Precise information on deadline(s) for review procedures:

You may submit any observations concerning the award procedure to the Contracting Authority indicated under heading I.1.

If you believe that there was maladministration, you may lodge a complaint to the European Ombudsman within 2 years of the date when you became aware of the facts on which the complaint is based (see http://www.ombudsman.europa.eu). Such complaint does not have as an effect either to suspend the time limit to launch an appeal or to open a new period for lodging an appeal.

Within 2 months of the notification of the award decision you may lodge an appeal to the body referred to in VI.4.1.

VI.4.4)Service from which information about the review procedure may be obtained
European Medicines Agency
30 Churchill Place
London
E14 5EU
United Kingdom
Telephone: +44 2036606000
E-mail: info@ema.europa.eu
Fax: +44 2036605555

Internet address: http://www.ema.europa.eu/ema/

VI.5)Date of dispatch of this notice:
04/10/2018