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Tender Details
- Country: Czech Republic
- Summary: Support of Mdriia Clinical Study
- CZT Ref No: 113416086
- Deadline: 28 Jan 2025
- Competition: ICB
- Financier: Self Financed
- Purchaser Ownership: Public
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: N006/25/V00001292
- Purchaser's Detail :
- Description :
- 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
- Documents :
Purchaser : KARDDI IS TECHNOLOGIES S.O.
Vendula Prchalová Dránkone NO: +420 776173567
Email :vendula@kardi-ai.com
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