Poland - Research and experimental and development services

Description

Comprehensive CRO(Contract Research Organization) service in a non-commercial clinical trial in two centers, together with preparation, configuration, provision of the Electronic Clinical Observation Card eCRF(Electronic Case Report Form) system together with the IWRS (Interactive Web Response System) module for the implementation of the POL PRENATAL CMV project".Zam. declares that, being a data controller and having regard to the provisions of the Act of 10..5.2018 on the protection of personal data (hereinafter RODO), has implemented security measures adequate to the risks identified by it and providing guarantees of proper protection of personal data transferred as part of the proceedings.A detailed information clause from Article 13 RODO is included in the SWZ.The Contracting Authority does not require a deposit.The Contracting Authority does not provide for the possibility of awarding contracts referred to in Article 214(1)(7).The Contracting Authority provides for the application of the so-called reverse procedure referred to in Article 139(1) of the PPL Act.
Detailed description and method of execution of the order is contained in Annexes no. 2 and 4 to the SWZ.The proceedings are conducted within the framework of the implemented project: "Comparison of the efficacy and safety of valacyclovir in the prevention of transmission and treatment of intrauterine infection in pregnant women with primary cytomegalovirus infection depending on the drug dose used - the first Polish non-commercial non-inferiority clinical trial POL PRENATAL CMV". - under contract no. 2022/ABM/03/00007 - 00 dated 09.05.2023 with the Medical Research Agency. (1) The Contracting Authority shall require the submission of the following subject evidence with the bid, under pain of nullity, in electronic form, to confirm that the offered service meets the requirements specified by the Contracting Authority:1) List of persons with additional professional experience (evaluated criterion) constituting Appendix No. 8a to the SWZ.2) Documents confirming the information (experience data) given in the list referred to in item 1).2. The Contracting Authority provides for the possibility of supplementing (submitting) the subject evidence if the Contractor fails to submit the subject evidence or the submitted subject evidence is incomplete only to the extent indicated in paragraph 3. The Contractor may supplement the subject evidence, but only at the request of the Contracting Authority.3.. the Contracting Authority shall provide for supplementing the subject evidence in order to demonstrate the Contractor's compliance with the minimum requirements for personnel experience (supplementing the documents indicated in paragraph 1 to the extent of demonstrating (supplementing the list and documents confirming the experience data provided in the list) the experience of the Clinical Trial Manager in the form of possession of the qualifications indicated in the Parent. VII. 2.4. para. 2. lit. a) of the ToR and in terms of demonstrating (supplementing the list and documents confirming the experience data given in the list) the experience of the Clinical Trial Specialist in the form of having the qualifications indicated in sb. VII. 2.4.(2)(b) of the SWZZ. The minimum personnel requirements should be understood as the minimum conditions necessary for the execution of the contract, the fulfillment of which must be demonstrated by the Contractor, in order to confirm that the offered services comply with the minimum requirements of the Contracting Authority (the experience of the personnel confirms the quality of the offered service).4. The evidence in question, if it serves to award points in accordance with the specified bid evaluation criteria, may be supplemented only to confirm the absence of grounds for rejection of the bid, but may not be supplemented to serve to obtain points in the bid evaluation criteria. A contractor shall not be awarded points, in accordance with the bid evaluation criteria, on the basis of the evidence in question submitted in accordance with paragraphs 2 and 3.

Opportunity closing date

16 August 2023

Value of contract

to be confirmed