IIT study CLEAR "Combining Loncastuximab Tesirine and Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)"

The IIT (Investigator Initiated Trial) study CLEAR "Combining Loncastuximab Tesirine and Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)" should take place in 26 trial sites in Germany and 4 trial sites in Italy. The University of Münster acts as sponsor of the clinical trial CLEAR according to Article 2 …

CPV: 71335000 Estudios de ingeniería
Plazo:
21 de noviembre de 2024 a las 12:00
Tipo de plazo:
Presentación de una oferta
Lugar de ejecución:
IIT study CLEAR "Combining Loncastuximab Tesirine and Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)"
Organismo adjudicador:
Universitätsklinikum Münster
Número de premio:
GBBM20241021LG_1

1. Buyer

1.1 Buyer

Official name : Universitätsklinikum Münster
Legal type of the buyer : Body governed by public law, controlled by a regional authority
Activity of the contracting authority : Health

2. Procedure

2.1 Procedure

Title : IIT study CLEAR "Combining Loncastuximab Tesirine and Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)"
Description : The IIT (Investigator Initiated Trial) study CLEAR "Combining Loncastuximab Tesirine and Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)" should take place in 26 trial sites in Germany and 4 trial sites in Italy. The University of Münster acts as sponsor of the clinical trial CLEAR according to Article 2 No. 14 Regulation (EU) 536/2014 (CTR). For the conduct of the study in Italy, we would like to transfer the following tasks in the areas of project management, trial start-up, monitoring and quality assurance to another institution in Italy. A synopsis of the study is attached to this tender as Appendix 1. A framework agreement will be concluded afterwards.
Procedure identifier : 39ab6b8e-72b1-4b74-a130-c35aecca2c19
Internal identifier : GBBM20241021LG_1
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 : Services
Main classification ( cpv ): 71335000 Engineering studies

2.1.2 Place of performance

Postal address : Universitätsklinikum Münster Albert-Schweitzer-Campus 1 Gebäude A3
Town : Münster
Postcode : 48149
Country subdivision (NUTS) : Münster, Kreisfreie Stadt ( DEA33 )
Country : Germany

2.1.4 General information

Additional information : Bekanntmachungs-ID: CXS0YYGY1WZ4K6LZ An dieser Stelle keine weiteren Informationen nötig.
Legal basis :
Directive 2014/24/EU
vgv -

2.1.6 Grounds for exclusion

Analogous situation like bankruptcy under national law : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Bankruptcy : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Corruption : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Arrangement with creditors : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Participation in a criminal organisation : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Agreements with other economic operators aimed at distorting competition : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Breaching of obligations in the fields of environmental law : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Money laundering or terrorist financing : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Fraud : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Child labour and other forms of trafficking in human beings : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Insolvency : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Breaching of obligations in the fields of labour law : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Assets being administered by liquidator : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Guilty of misrepresentation, withheld information, unable to provide required documents and obtained confidential information of this procedure : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Conflict of interest due to its participation in the procurement procedure : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Direct or indirect involvement in the preparation of this procurement procedure : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Guilty of grave professional misconduct : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Early termination, damages or other comparable sanctions : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Breaching of obligations in the fields of social law : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Payment of social security contributions : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Business activities are suspended : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Payment of taxes : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB
Terrorist offences or offences linked to terrorist activities : Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB

5. Lot

5.1 Lot technical ID : LOT-0001

Title : IIT study CLEAR "Combining Loncastuximab Tesirine and Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)"
Description : The IIT (Investigator Initiated Trial) study CLEAR "Combining Loncastuximab Tesirine and Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)" should take place in 26 trial sites in Germany and 4 trial sites in Italy. The University of Münster acts as the sponsor of the clinical trial CLEAR according to Article 2 No. 14 Regulation (EU) 536/2014 (CTR). Evaluation of Offers and Award Criteria All requirements for the bidder or their offer are defined as criteria and are divided into two types: Exclusion Criteria (A-Criteria) Evaluation Criteria (B-Criteria) Exclusion criteria are criteria that must be fully met by the bidders, meaning that the requirements behind them are indispensable for the contracting authority. These criteria are marked with the letter [A] in the criteria catalog. Offers that do not fully meet all A-Criteria will be excluded from the procurement process. Evaluation criteria are criteria that allow for differentiated responses from the bidders. These criteria are marked with the letter [B] in the criteria catalog. The bidder must answer the listed requirements in detail. If the demands marked with (A), i.e., exclusion criteria, are not clearly answered, for example, with "Yes" or unconditionally affirming in the sense of the respective A-criterion, or if the required evidence and explanations are not provided, the criterion is considered unmet, and the offer will not be further considered, even if the bidder performs exceptionally well in other areas. The evaluation of the (B)-criteria is based on the degree of fulfillment. Failure to meet or provide a response to a (B)-criterion does not result in exclusion but will be rated with 0 points. Excellent fulfillment is awarded a maximum of 10 points. The weighting scheme for the individual criterion (main) groups (abbreviated as KHG, KG) can be found in the criteria description. Please note that for printing optimization reasons, the detailed point scheme (see Excel® file "CRO Evaluation Matrix.xlsx") is located outside the preset print area and is best reviewed directly in the electronic version. The total score is calculated as follows: All offers are evaluated based on the weighting scheme embedded in the evaluation matrix. The points awarded are multiplied by the predetermined weighting points. The results are summed to determine the total score for each offer. The contracting authority explicitly points out that bidders must carefully and thoroughly address the requirements and answer the questions in detail. Missing information and lack of comparability will directly negatively affect the evaluation of the offers. Selection of Bidders Measures after the Opening of Offers: 1. Formal review of the offers and exclusion of those that do not meet the formal requirements. 2. Review of the A-Criteria and exclusion of offers that do not meet the A-Criteria. 3. Evaluation of each criterion (B-Criteria) for each offer according to the evaluation matrix. Awarding of evaluation points (0 to 10) for each individual criterion. Determination of performance points (B-Criteria) by multiplying the awarded evaluation points by the weighting points. 4. Determination of the result of the performance evaluation (suitability) for each offer. 5. Evaluation of the pricing structure.
Internal identifier : GBBM20241021LG_1

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 71335000 Engineering studies

5.1.2 Place of performance

Postal address : Universitätsklinikum Münster Albert-Schweitzer-Campus 1 Gebäude A3
Town : Münster
Postcode : 48149
Country subdivision (NUTS) : Münster, Kreisfreie Stadt ( DEA33 )
Country : Germany
Additional information :

5.1.3 Estimated duration

Duration : 54 Month

5.1.4 Renewal

Maximum renewals : 0

5.1.6 General information

The names and professional qualifications of the staff assigned to perform the contract must be given : Not yet known
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

5.1.9 Selection criteria

Criterion :
Type : Economic and financial standing
Name : Wirtschaftliche und finanzielle Leistungsfähigkeit
Description : Supporting documents: - Erklärung über den Gesamtumsatz des Unternehmens + den Umsatz bezüglich der besonderen Leistungsart, die Gegenstand der Vergabe ist, jeweils bezogen auf die letzten 3 Geschäftsjahre (To be submitted with the tender by means of self-declaration) - Nachweis, dass eine Betriebshaftpflichtversicherung besteht, sowie deren Höhe (nicht älter als 6 Monate) (To be submitted with the tender by means of self-declaration)
Criterion :
Type : Other
Name : Sonstiges
Description : Supporting documents: - Darstellung des sich bewerbenden Unternehmens inkl. Leistungsportfolios (max. 4 DINA4-Seiten) (To be submitted with the tender by means of self-declaration) - Für ausländische Bewerber ist der Nachweis der Eignung auch durch amtliche Bescheinigungen gleichwertiger Art möglich (To be submitted with the tender by means of self-declaration)
Criterion :
Type : Suitability to pursue the professional activity
Name : Eignung zur Berufsausübung
Description : Supporting documents: - Erklärungen zum Ausschluss der Tatbestände des § 123 und §124 GWB (To be submitted with the tender by means of self-declaration) - Nachweis über Eintragung in das Berufs- o. Handelsregister ggf. nach Rechtsvorschriften des Landes der Gemeinschaft, in dem der Bieter ansässig ist (nicht älter als 6 Monate) (To be submitted with the tender by means of self-declaration)
Criterion :
Type : Technical and professional ability
Name : Technische und berufliche Leistungsfähigkeit
Description : Supporting documents: - Angabe und Größe der Mitarbeiterentwicklung der letzten 3 Jahre (To be submitted with the tender by means of self-declaration) - Referenzen (To be submitted with the tender by means of self-declaration): Referenzliste der letzten drei Jahre (Kunden mit Namen eines Ansprechpartners und Kontaktdaten)

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : English
Deadline for requesting additional information : 13/11/2024 23:59 +01:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : German, English
Electronic catalogue : Not allowed
Variants : Not allowed
Tenderers may submit more than one tender : Not allowed
Deadline for receipt of tenders : 21/11/2024 12:00 +01:00
Deadline until which the tender must remain valid : 60 Day
Information that can be supplemented after the submission deadline :
At the discretion of the buyer, some missing tenderer-related documents may be submitted later.
Additional information : Unternehmensbezogene Unterlagen werden nachgefordert
Information about public opening :
Opening date : 21/11/2024 12:00 +01:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Conditions relating to the performance of the contract : Supporting documents: - Erklärung, dass die Auftrags- und Lieferbedingungen des Auftraggebers anerkannt werden und die AGB des Auftragnehmers keine Anerkennung finden (To be submitted with the tender by means of self-declaration) - Erklärung, dass die Ausschreibungsbedingungen anerkannt werden (To be submitted with the tender by means of self-declaration)
Electronic invoicing : Required
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system
Electronic auction : no

5.1.16 Further information, mediation and review

Review organisation : Vergabekammer Westfalen bei der Bezirksregierung Münster
Organisation providing additional information about the procurement procedure : Universitätsklinikum Münster
Organisation receiving requests to participate : Universitätsklinikum Münster
TED eSender : Datenservice Öffentlicher Einkauf (in Verantwortung des Beschaffungsamts des BMI)

8. Organisations

8.1 ORG-0001

Official name : Universitätsklinikum Münster
Registration number : 05515-99003-03
Postal address : Albert-Schweitzer-Campus 1 Gebäude A3
Town : Münster
Postcode : 48149
Country subdivision (NUTS) : Münster, Kreisfreie Stadt ( DEA33 )
Country : Germany
Contact point : Geschäftsbereich Beschaffungsmanagement
Telephone : +49 2518348600
Fax : +49 2518348839
Roles of this organisation :
Buyer

8.1 ORG-0002

Official name : Universitätsklinikum Münster
Registration number : 05515-99003-03
Postal address : Albert-Schweitzer-Campus 1 Gebäude A3
Town : Münster
Postcode : 48149
Country subdivision (NUTS) : Münster, Kreisfreie Stadt ( DEA33 )
Country : Germany
Contact point : Geschäftsbereich Beschaffungsmanagement
Telephone : +49 2518348600
Fax : +49 2518348839
Roles of this organisation :
Organisation providing additional information about the procurement procedure

8.1 ORG-0003

Official name : Vergabekammer Westfalen bei der Bezirksregierung Münster
Registration number : 05515-03004-07
Postal address : Albrecht-Thaer Str. 9
Town : Münster
Postcode : 48147
Country subdivision (NUTS) : Münster, Kreisfreie Stadt ( DEA33 )
Country : Germany
Telephone : +49 2514111691
Roles of this organisation :
Review organisation

8.1 ORG-0004

Official name : Universitätsklinikum Münster
Registration number : 05515-99003-03
Postal address : Albert-Schweitzer-Campus 1 Gebäude A3
Town : Münster
Postcode : 48149
Country subdivision (NUTS) : Münster, Kreisfreie Stadt ( DEA33 )
Country : Germany
Contact point : Geschäftsbereich Beschaffungsmanagement
Telephone : +49 2518348600
Fax : +49 2518348839
Roles of this organisation :
Organisation receiving requests to participate

8.1 ORG-0005

Official name : Datenservice Öffentlicher Einkauf (in Verantwortung des Beschaffungsamts des BMI)
Registration number : 0204:994-DOEVD-83
Town : Bonn
Postcode : 53119
Country subdivision (NUTS) : Bonn, Kreisfreie Stadt ( DEA22 )
Country : Germany
Telephone : +49228996100
Roles of this organisation :
TED eSender

11. Notice information

11.1 Notice information

Notice identifier/version : b87c7c8b-07db-4707-897e-ba7eb14403db - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 21/10/2024 13:32 +02:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00639713-2024
OJ S issue number : 206/2024
Publication date : 22/10/2024