Public procurement notice: Contract Award Notice
Published: 2021-06-07
Buyer: Helmholtz-Zentrum für Infektionsforschung GmbH
Country: DE
Contract type: Services
Procedure: Open procedure
CPV classification: 48814000: Medical information systems | 73000000
Estimated value: 363485 EUR
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 Organization (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 harmonize 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 procurement procedure is subject to the regulations on the review procedure before the Public Procurement Tribunal and Senate (§§ 155 ff. Act against Restraints of Competition (Competition Act — GWB)).
1) The applicant became aware of the claimed violation of public procurement provisions before filing the application for review, but did not complain to the contracting authority within a time limit of 10 calendar days; the expiry of the time limit under § 134(2) remains unaffected;
2) Violations of public procurement provisions which become apparent from the tender notice are not notified to the contracting authority by the end of the time limit for the application or the submission of a tender specified in the notice;
3) Violations of public procurement provisions which only become apparent from the procurement documents are not notified to the contracting authority by the end of the time limit for the application or the submission of a tender specified in the notice;
4) More than 15 calendar days have expired since receipt of notification from the contracting authority that it is unwilling to redress the objection.
The contracting authority is obliged to send the bidder information no later than 10 days before the award of the contract (§ 134 GWB).
After the award of the contract (conclusion of the contract), an application for review is no longer permitted. This does not apply to requests to establish that the contract is ineffective in accordance with § 135 (1) GWB, i.e. due to a breach of the aforementioned obligation to provide information to bidders and compliance with the waiting period in accordance with § 134 GWB or due to inadmissible awards without prior publication of a notice in the Official Journal of the EU. Such requests to establish the ineffectiveness of the contract are only permitted within 30 calendar days after the contracting authority has informed the bidders and applicants concerned about the conclusion of the contract, but no later than six months after the conclusion of the contract. If the contracting authority has announced the award of the contract in the Official Journal of the European Union, the period for asserting the ineffectiveness ends 30 calendar days after the publication of the announcement of this award in the Official Journal of the European Union.


Winner: Harmony Clinical Research BVBA
Award value: 363485
Number of bids: 2