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Germany-Brunswick: Research and development services and related consultancy services
Section I: Contracting authority
Section II: Object
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:
1) The elderly ≥ 60 years;
2) Children 3-8 years;
3) Infants 6 months.
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:
1) Elderly ≥ 60 years;
2) Children 3-8 years; and
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.
Grant agreement 874866.
Section III: Legal, economic, financial and technical information
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.
— 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.
— Self-declaration of the total revenue (see tender document – Self-declarations by the bidder).
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.
— at the time of submitting the bid, the bidder must maintain business or professional liability insurance coverage with a minimum coverage of EUR 1 million for personal injury and EUR 1 million for property damage and financial loss per claim;
— If the bidder does not have business or professional liability insurance with the appropriate coverage at the time of submission of the bid, an irrevocable promise by the bidder's insurance company to increase the coverage amount accordingly in the event of being awarded the contract can be presented as first evidence (insurance policy with increased coverage amounts must be available before the award date);
— If business liability insurance has not yet been taken out, the bidder is obliged to take out business liability insurance with the specified coverage in the event that the bidder is awarded the contract.
(a) relevant experience: please provide a brief summary of your experience and capabilities from the last 3 years as a Clinical Research Organisation (CRO), particularly in vaccine trials. This should include the following:
(i) range of services you provide;
(ii) a summary of the trials you have worked on, and the different stages of drug development. Please include a list of the trials you have worked on in the past five (5) years and any available reference letters;
(iii) a summary of the facilities and staffing, including system/software you are using for data management and monitoring, as well as your approach to security and compliance with the General Data Protection Regulation (GDPR);
(iv) feasibility/experience in remote monitoring (in the scenario of a continued lockdown due to the Covid-19 pandemic);
(b) please provide the date and the approving authority to conduct Good Clinical Practice (GCP) studies and the date of your last regulatory audit, as well as a summary of the findings and responses, if any;
(c) past performance: your performance as CRO in executing previous projects in terms of quality, timeframe, and budget. Audit reports, reviews, and references from previous customers can provide useful information in this regard.
References at least 3 corresponding references with the following requirements:
• completed contract services;
• type of work: services comparable to the subject matter of this tender;
• scope of the work: references for services each costing at least 20 % of the bid price for this tender.
— References that do not meet the aforementioned minimum requirements will not be recognised. The client will check the specified references on a random basis. Incorrect or erroneous information will lead to the reference not being taken into account. If the required minimum number of references is not reached as a result, the project-specific suitability will be deemed as not proven. The bid will be excluded from consideration. The amendment of declarations that have already been made is not permitted.
See tender documents.
Section IV: Procedure
Administration building, Building W, Dept. Purchasing (EM).
No bidders are allowed at the opening of the bids.
Section VI: Complementary information
Precise information on deadline(s) for review procedures:
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)).
Pursuant to § 160 (3) GWB, any request for a review is inadmissible if
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.