The document outlines a clinical trial on a medical device conducted for an Italian producer, focusing on assessing clinical efficacy in traumatology and commercial competitiveness. Key elements include a randomized controlled trial design, rigorous data collection, and compliance with good clinical practices. The trial aimed to optimize data efficiency while comparing the device against major competitors through a well-defined methodology.

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. 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. 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. 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. 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