Clinical trial on Medical Device: complete development
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Transcript of Clinical trial on Medical Device: complete development
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Case 1: Clinical trial on Medical Device: complete development
• Post-market Randomized Clinical Trial on Medical Device
1Copyright © 2013 Zeta Research S.r.l.
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Copyright © 2013 Zeta Research S.r.l.
Client:Italian Class I and II MD producer with international business network
Client’s aims:Product’s evaluation concerning both clinical efficay (in traumatology) and commercial competitivity.
Specific advanced requirements: RCT vs major pharma competitor Time and costs optimization Rigorous and transaprent data collected Compliance at Good Clinical Practice
Case 1
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Copyright © 2013 Zeta Research S.r.l.
Proposed solution:
• Scientific planning of the trial, starting from scientific literature and producer’s technical and clinical data
• Aims and endpoint definition• Sample caculation• Inclusion and exclusion criteria definition
• Study design:• Randomized• Three treatment arms; MD’s comparators:
1. pharma major competitor2. natural medicine major competitor
• eCRF drafting and programming for electronic data collection• Remote data management
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Copyright © 2013 Zeta Research S.r.l.
Methods and tools
• Scientific literature review on the major database (PubMed,
Scopus etc)
• Ethic documentations and approval management by an IEC.
• Ad hoc eCRF drafting
• Principal Investigator and site selection
• Web-based data collection
• IWRS for randomization and unblinding
• Site monitoring
• In house data analisys and reporting
• GCP conformity
Sviluppo completo di studio clinico su Medical Device
Caso 1
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Copyright © 2013 Zeta Research S.r.l.
Client’s satisfied aims:
Case 1
•Data optimization and efficiency according to endpoints
•Clear reporting
• Rigorous and transparent data and resources optimization
•Usefull data for clinical and market product’s positioning
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