Conducting Allergy and Clinical Studies

Summary

The tender concerns allergy and clinical research services for the contracting authority’s research project. The work will assess the immune reactivity of hypoallergenic bakery products made with gluten proteins whose allergenic composition has been modified, as well as the effects of dietary intervention on patients’ wellbeing, allergic inflammation and gut microbiota. The services are divided into two stages. In Stage I, the contractor must recruit and screen 15 patients, collect blood samples, prepare serum, and conduct or arrange gluten-allergy investigations: skin prick tests, ALEX2 multiplex diagnostics and basophil activation tests. The contractor must document and analyse the results and submit reports. The contractor must obtain patients’ informed consent and approval from the bioethics committee, and comply with personal-data protection rules and Good Clinical Practice. In Stage II, the contractor will carry out dietary tests with 15 patients, assess results using the VAS scale and the SF-36 quality-of-life questionnaire, measure indicators of allergic inflammation—including blood counts, a peripheral blood differential, a pro-inflammatory cytokine profile and IgE—and assess gut microbiota in stool samples. Patients from Stage I should normally take part in Stage II, although other patients may be recruited if needed. Samples, results and a report for each work sub-stage must be delivered to the contracting authority. Stage I runs from contract signature until 31 October 2027, and Stage II from 1 November 2027 to 31 October 2028. Partial bids are not permitted. The bidder must provide at least one person with a doctoral degree or higher in allergology to lead the research and at least two physicians who are allergology specialists or residents in that specialty. The offer must include the required personnel list and a declaration concerning exclusion grounds and participation conditions. Price accounts for 60% of the evaluation and team qualifications for 40%; the fixed lump-sum price must cover all costs of performance. The offer must be submitted electronically in Polish with the required signature. No bid security or performance security is required.