Public procurement notice: Contract Notice
Published: 2021-03-30
Buyer: Helmholtz-Zentrum für Infektionsforschung GmbH
Country: DE
Contract type: Services
Procedure: Open procedure
CPV classification: 48814000: Medical information systems | 73000000
Submission deadline: 2021-04-26
Award criteria: The most economic tender

Technical requirements: Tender Specifications for the Support of three Phase IV Studies in Europe with QIV Vaccine Against Influenza
A Clinical Research Organisation (CRO) is being sought to support three Phase IV clinical studies that will take place as part of an EU-funded project. The studies will be conducted with a QIV vaccine in vulnerable populations, including three age groups:
In Europe, three research institutions will be involved (University of Antwerp, University of Bergen, Université Libre de Bruxelles), which will be responsible for recruiting the respective age group. To support the three clinical centers in their studies in Europe, the following services are required from a CRO: clinical data management, clinical monitoring and SAE reporting.
University of Antwerp Center for Evaluation of Vaccination Campus Drie Eiken, Gebouw R Universiteitsplein 1 2610 Wilrijk, Belgium Université Libre de Bruxelles Institute for Medical Immunology (IMI) Campus de Charleroi — Gosselies (Biopark) — CP 305 Rue Prof. Jeener and Brachet, 12 6041 Gosselies, Belgium The Influenza Center University of Bergen and Haukeland University Hospital The Laboratory Building 5021 Bergen, Norway.
The ‘Indo-European Consortium for Next Generation Influenza Vaccine Innovation’ (Acronym: Incentive) is a large international research consortium funded by the European Union (EU) and the Indian government to address the global health and economic challenge posed by influenza infections with the aim to reduce the worldwide burden resulting from outbreaks. One of the objectives of Incentive is to conduct Phase IV trials in vulnerable populations including three age groups:
The trials will be conducted in parallel in Europe and India with the same quadrivalent commercially available influenza vaccine (QIV). One hundred and fifty (150) participants will be enrolled in each of the age groups, with 50 in Europe and 100 in India. The objective is to identify correlates of responsiveness across EU and India, predicting responses versus non responses and the quality of responses to influenza vaccines across populations and according to gender.
In Europe, three research institutions will be involved (University of Antwerp, University of Bergen, Université Libre de Bruxelles), responsible for the enrolment of the respective age group. While each will be conducted as an independent trial, we strive to harmonise across these trials and with the counterparts in India whenever possible. The support requested under this tender is for a Clinical Research Organization (CRO) for all three trials in Europe.
The suitability for the service to be awarded in terms of III.1.1) Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registers III.1.2) Economic and financial standing III.1.3) technical and professional ability is to be proven through appropriate documentation with the bid. This can be by self-declaration using either the tender document (Self-declarations by the bidder) or the European Single Procurement Document (ESPD).
Certificates/supporting documents to be submitted must not exceed the current validity date or – if they do not indicate a validity period — not be older than 1 year at the time the bid is opened. Any changes to the facts listed must be brought to our attention immediately. Deliberately inaccurate declarations with regard to the suitability check will lead to the exclusion of the bid.
Bidders must submit equivalent certificates from recognised bodies from their country of origin for themselves and, if applicable, other companies. Certificates that are not in German or English must be accompanied by a translation in German or English.
1) Information about the entry in the professional or commercial register or the trade register of the registered office or place of residence or a comparable register for foreign bidders;
3) Information that there is no evidence that serious misconduct has been committed that would call into question the reliability of the bidder;
— Self-declaration on §§ 123, 124 Competition Act - GWB (Act against Restraints of Competition) (see tender document — Anti-corruption clause).
The bidder has to prove his reliability. For this purpose, a completed self-declaration on §§ 123, 124 Competition Act - GWB (see tender document — Anti-corruption clause) in text form in accordance with § 126b BGB (German Civil Code) must be submitted with the bid.
Declaration of the company's revenue related to the last 3 completed financial years, insofar as it relates to services that are comparable to the service to be awarded, including the proportion of contracts carried out jointly with other companies -> Observe any minimum level(s) of standards possibly required the average total revenue yearly must be at least three-times the value of the bid.

Eligibility requirements: Basic regulations for points III.1.1) + III.1.2) + III.1.3): The suitability for the service to be awarded in terms of III.1.1) Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registers III.1.2) Economic and financial standing III.1.3) technical and professional ability is to be proven through appropriate documentation with the bid. This can be by self-declaration using either the tender document (Self-declarations by the bidder) or the European Single Procurement Document (ESPD). Certificates/supporting documents to be submitted must not exceed the current validity date or – if they do not indicate a validity period — not be older than 1 year at the time the bid is opened. Any changes to the facts listed must be brought to our attention immediately. Deliberately inaccurate declarations with regard to the suitability check will lead to the exclusion of the bid. Bidders must submit equivalent certificates from recognised bodies from their country of origin for themselves and, if applicable, other companies. Certificates that are not in German or English must be accompanied by a translation in German or English. Re III.1.1) Suitability to pursue the professional activity — the following conditions must be met: 1) Information about the entry in the professional or commercial register or the trade register of the registered office or place of residence or a comparable register for foreign bidders; 2) Information on insolvency proceedings and liquidation; 3) Information that there is no evidence that serious misconduct has been committed that would call into question the reliability of the bidder; 4) Information on the proper payment of taxes, duties; 5) Information on the proper payment of social security contributions; 6) Information about the proper payment of the contributions to accident insurance.