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

Kurze Beschreibung

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.

Beschreibung der Beschaffung

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.

Liste und kurze Beschreibung der Auswahlkriterien

Wirtschaftliche und finanzielle Leistungsfähigkeit: 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)

Liste und kurze Beschreibung der Regeln und Kriterien

Sonstiges: 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)

Liste und kurze Beschreibung der Bedingungen

Eignung zur Berufsausübung: 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)

Liste und kurze Beschreibung der Auswahlkriterien

Technische und berufliche Leistungsfähigkeit: 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)

Bedingungen für die Vertragserfüllung

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)