Support of Mdriia Clinical Study Tender, Czech Republic - 113416086

Procurement Summary

Country : Czech Republic

Summary : Support of Mdriia Clinical Study

Deadline : 28 Jan 2025

Other Information

Notice Type : Tender

TOT Ref.No.: 113416086

Document Ref. No. : N006/25/V00001292

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

The demanded consulting services concern the preparation of the clinical examination of the cardi medical device, support during the implementation and overall evaluation of the clinical examination. The main activities will include: - statistical consultations over the design of the study - calculating the "sample size" for the study - design of the synopsis of the study, including consultation with an expert - a clinical trial design (CIP), including Risk analysis according to ISO 14155 ) and Monitoring of the Plan (PM) - Consultation over data transfer from the Cardi AI to the Statistical System - ECRF design, data collection process and data management data - Revision of the EC - Preparation of the data analysis plan - SUKL communication and documentation to the documentation RZPRO - Project management, communication with the contracting authority - processing of documentation according to the contracting authority 'request ” - statistical evaluation of the clinical examination - final report from the clinical examination
Current Status of ZP: not ended
Division intoo Parts: no
ZP Identifier on the Contracting Authority's profile:
Type of entry procedure: open challenge
Procurement Specifications: Open Challenge
Kind of of: Public Procurement for Services
DATE OF PUBLICATION OF THE PROFILE:
Code from CPV dial: 73200000
Name from CPV dial: Counseling Voblasti Research and Subject Name: Counseling Voblasti Research and Text box for description of the filling point:
Nipez code list code: 73200000-4
Name from Nipez dial: Counseling in Research and Development
Main place of performance: Counseling in the field of research and development

Documents

 Tender Notice