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Clinical trial on Medical Device: complete development

Product’s evaluation concerning both clinical efficay (in traumatology) and
commercial competitivity.

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Clinical trial on Medical Device: complete development

  1. 1. Case 1: Clinical trial on Medical Device: complete development • Post-market Randomized Clinical Trial on Medical Device Copyright © 2013 Zeta Research S.r.l. 1
  2. 2. Case 1 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 Copyright © 2013 Zeta Research S.r.l. 2
  3. 3. Case 1 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 competitor 2. natural medicine major competitor • • eCRF drafting and programming for electronic data collection Remote data management Copyright © 2013 Zeta Research S.r.l. 3
  4. 4. Sviluppo completo di studio clinico su Medical DeviceCaso 1 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 Copyright © 2013 Zeta Research S.r.l. 4
  5. 5. Case 1 Client’s satisfied aims: • 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 Copyright © 2013 Zeta Research S.r.l. 5

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