Case 1: Clinical trial on Medical Device: complete development

• Post-market Randomized Clinical Trial on Medical Device

1Copyright © 2013 Zeta Research S.r.l.

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

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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

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Copyright © 2013 Zeta Research S.r.l.

Client’s satisfied aims:

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•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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