REQUEST FOR QUOTATION No 1/2026
Notice description
In connection with the implementation by the Ordering Party of research and development project entitled " Development of a hard tissue and biofilm diagnostic module based on optical technology and artificial intelligence, integrated with routine intraoral scanning without extending the procedure time” applying for funding in the call no. FENG.01.01-IP.02-001/26 under the European Funds for Smart Economy program hereinafter "Project" the Ordering Party submits the inquiry regarding the implementation of the Research services.
Part of the order: Part 1
CPV name and code: 73110000-6 Research services.
Provision of Contract Research Organization (CRO) Clinical Monitoring Services for a multicenter dental clinical study enrolling approximately 1000 patients. The study will be conducted in Poland. The CRO must operate in full compliance with ICH E6(R2)/E6(R3) Good Clinical Practice, European Medicines Agency (EMA) regulatory framework, EU Clinical Trial Regulation (EU) No 536/2014, applicable Polish national regulations, Israeli Ministry of Health regulations (if applicable), and GDPR requirements.
• Site initiation visits (SIVs)
• Routine on-site and/or remote monitoring visits
• Risk-Based Monitoring (RBM) implementation
• Source Data Verification (SDV) and Source Data Review (SDR)
• Verification of informed consent procedures
• Oversight of protocol adherence and deviation reporting
• AE/SAE verification (if applicable)
• eCRF review and query management
• Monitoring reports within agreed timelines
• Close-out visits (COVs)
• Inspection readiness support
• Oversight of approximately 1000 dental patients across multiple investigational sites
The Ordering Party does not allow the possibility of submitting partial offers (1 part of the subject of the order).
The Ordering Party does not allow the possibility of submitting variant offers.
II.2. RULES OF ORDER EXECUTION:
ORDER COMPLETION DATE: Deadline for Completion of the scope of work: The cooperation duration shall be 36 months from the date of signature of agreement. The conditional agreement will only come into effect if the Contracting Authority concludes a funding agreement for the project. The order completion date is an admission condition, tenders indicating a longer duration will be rejected.
PAYMENT TERMS: payment deadline for an invoice of not less than 30 calendar days from receipt of correctly issued invoice. Invoices will be issued based on faultless acceptance protocols for a given task (of deliverables) signed by both parties to the contract. The payment deadline is an admission condition, tenders indicating a shorter deadline will be rejected. Payments will be made according to schedule that will be agreed after signing the agreement. No advance payments are envisaged.
AGREEMENT DATE: Orders under the contract will be executed from the signing of the contract until the date of completion of the relevant stages of the Projects. In the event of prolonging the completion date of any of the Projects or the relevant stage of the Project, the framework agreement may be extended following changes in the applications for co-financing of Projects.
PLACE, DATE AND PROCEDURE FOR SUBMISSION OF TENDERS:
1. Offers must be submitted via Baza konkurcyjnosci website: https://bazakonkurencyjnosci.funduszeeuropejskie.gov.pl/ by 16:00 CET at 30.04.2026.
2. The offer together with attachments should be made in Polish or English.
3. The offer should be prepared in accordance with the form constituting Appendix 1 to this inquiry.
4. The offer must be signed by persons authorized to represent the Bidder in accordance with the registration document or in accordance with the power of attorney granted. It is allowed to use an electronic signature (including a qualified electronic signature), a trusted signature (trusted profile) or provide a scan of a handwritten offer.
5. Timely submission of an offer is determined by the date of submission of the offer via the Competitiveness Database (BK2021).
6. The costs related to the preparation of the offer shall be borne by the Bidder.
7. Submitting an offer is tantamount to accepting without reservations the content of this RFQ together with attachments.
8. In the course of comparing and evaluating tenders, the Ordering Party shall correct obvious clerical and accounting errors in the tenders, at the same time informing the Bidder about the content of the amendment. If the Bidder does not agree to correct the errors within the time limit indicated by the Ordering Party, its offer shall be rejected.
9. The part of the offer that contains information constituting a trade secret within the meaning of the provisions on combating unfair competition, and the Contractor reserves their confidentiality, should be described as "Confidential". The Ordering Party shall not be liable for the disclosure of information constituting a trade secret provided to it by the Contractor contrary to the provisions of this subsection. A trade secret is understood as technical, technological, organizational information of the enterprise not disclosed to the public or other information of economic value for which the entrepreneur has taken the necessary measures to maintain their confidentiality, in accordance with the Act of 16 April 1993 on combating unfair competition (consolidated text: Journal of Laws of 2022, item 1233; binding text).
10. An offer that does not meet the requirements set out above shall be rejected, subject to the provisions on the possibility of allowing the Ordering Party to call on Bidders who have not submitted the required statements, or who have not submitted registration documents or powers of attorney, or who have submitted the above-mentioned statements and documents containing errors or incomplete or raising doubts indicated by the Ordering Party to their submission, supplementation or correction within the prescribed period, or to provide explanations, unless despite their submission the Bidder's offer would be rejected or the procedure would be subject to annulment. If the Bidder does not submit, supplement or correct the above-mentioned statements or documents within the time limit set by the Ordering Party, its offer shall be rejected. Subsequently, the committee will evaluate the offers in accordance with point IV.
OFFER VALIDITY PERIOD:
The offer should include its validity period at least until 30 September 2026.
The Ordering Party may request the Bidders to agree to extend the period of validity of the offer by the time needed to conclude the contract.
Miejsce realizacji
Cała polska
Part of the order: Part 1
CPV name and code: 73110000-6 Research services.
Provision of Contract Research Organization (CRO) Clinical Monitoring Services for a multicenter dental clinical study enrolling approximately 1000 patients. The study will be conducted in Poland. The CRO must operate in full compliance with ICH E6(R2)/E6(R3) Good Clinical Practice, European Medicines Agency (EMA) regulatory framework, EU Clinical Trial Regulation (EU) No 536/2014, applicable Polish national regulations, Israeli Ministry of Health regulations (if applicable), and GDPR requirements.
• Site initiation visits (SIVs)
• Routine on-site and/or remote monitoring visits
• Risk-Based Monitoring (RBM) implementation
• Source Data Verification (SDV) and Source Data Review (SDR)
• Verification of informed consent procedures
• Oversight of protocol adherence and deviation reporting
• AE/SAE verification (if applicable)
• eCRF review and query management
• Monitoring reports within agreed timelines
• Close-out visits (COVs)
• Inspection readiness support
• Oversight of approximately 1000 dental patients across multiple investigational sites
The Ordering Party does not allow the possibility of submitting partial offers (1 part of the subject of the order).
The Ordering Party does not allow the possibility of submitting variant offers.
II.2. RULES OF ORDER EXECUTION:
ORDER COMPLETION DATE: Deadline for Completion of the scope of work: The cooperation duration shall be 36 months from the date of signature of agreement. The conditional agreement will only come into effect if the Contracting Authority concludes a funding agreement for the project. The order completion date is an admission condition, tenders indicating a longer duration will be rejected.
PAYMENT TERMS: payment deadline for an invoice of not less than 30 calendar days from receipt of correctly issued invoice. Invoices will be issued based on faultless acceptance protocols for a given task (of deliverables) signed by both parties to the contract. The payment deadline is an admission condition, tenders indicating a shorter deadline will be rejected. Payments will be made according to schedule that will be agreed after signing the agreement. No advance payments are envisaged.
AGREEMENT DATE: Orders under the contract will be executed from the signing of the contract until the date of completion of the relevant stages of the Projects. In the event of prolonging the completion date of any of the Projects or the relevant stage of the Project, the framework agreement may be extended following changes in the applications for co-financing of Projects.
PLACE, DATE AND PROCEDURE FOR SUBMISSION OF TENDERS:
1. Offers must be submitted via Baza konkurcyjnosci website: https://bazakonkurencyjnosci.funduszeeuropejskie.gov.pl/ by 16:00 CET at 30.04.2026.
2. The offer together with attachments should be made in Polish or English.
3. The offer should be prepared in accordance with the form constituting Appendix 1 to this inquiry.
4. The offer must be signed by persons authorized to represent the Bidder in accordance with the registration document or in accordance with the power of attorney granted. It is allowed to use an electronic signature (including a qualified electronic signature), a trusted signature (trusted profile) or provide a scan of a handwritten offer.
5. Timely submission of an offer is determined by the date of submission of the offer via the Competitiveness Database (BK2021).
6. The costs related to the preparation of the offer shall be borne by the Bidder.
7. Submitting an offer is tantamount to accepting without reservations the content of this RFQ together with attachments.
8. In the course of comparing and evaluating tenders, the Ordering Party shall correct obvious clerical and accounting errors in the tenders, at the same time informing the Bidder about the content of the amendment. If the Bidder does not agree to correct the errors within the time limit indicated by the Ordering Party, its offer shall be rejected.
9. The part of the offer that contains information constituting a trade secret within the meaning of the provisions on combating unfair competition, and the Contractor reserves their confidentiality, should be described as "Confidential". The Ordering Party shall not be liable for the disclosure of information constituting a trade secret provided to it by the Contractor contrary to the provisions of this subsection. A trade secret is understood as technical, technological, organizational information of the enterprise not disclosed to the public or other information of economic value for which the entrepreneur has taken the necessary measures to maintain their confidentiality, in accordance with the Act of 16 April 1993 on combating unfair competition (consolidated text: Journal of Laws of 2022, item 1233; binding text).
10. An offer that does not meet the requirements set out above shall be rejected, subject to the provisions on the possibility of allowing the Ordering Party to call on Bidders who have not submitted the required statements, or who have not submitted registration documents or powers of attorney, or who have submitted the above-mentioned statements and documents containing errors or incomplete or raising doubts indicated by the Ordering Party to their submission, supplementation or correction within the prescribed period, or to provide explanations, unless despite their submission the Bidder's offer would be rejected or the procedure would be subject to annulment. If the Bidder does not submit, supplement or correct the above-mentioned statements or documents within the time limit set by the Ordering Party, its offer shall be rejected. Subsequently, the committee will evaluate the offers in accordance with point IV.
OFFER VALIDITY PERIOD:
The offer should include its validity period at least until 30 September 2026.
The Ordering Party may request the Bidders to agree to extend the period of validity of the offer by the time needed to conclude the contract.
Miejsce realizacji
Cała polska
Time limit for receipt of tenders
2026-05-08 21:59:59.0
Location
Kraj: Polska
Category assortment
Measurements, tests and technical acceptance
Buyer details
LUMINX PL Sp. z o.o.
Wolska 58/1
01-134 Warszawa
Województwo: mazowieckie
Kraj: Polska
NIP: 5273210064
Wolska 58/1
01-134 Warszawa
Województwo: mazowieckie
Kraj: Polska
NIP: 5273210064
