planning and management of a clinical trial abroad
DESCRIPTION
A post-market Medical Device clinical trial in an extra-EU countryTRANSCRIPT
CRO4Q Contract Research Organization
Best practice
Copyright © 2013 Zeta Research S.r.l.
Case 4:
Planning and management of a clinical trial abroad
• A post-market Medical Device clinical trial in an extra-EU country
2 Copyright © 2013 Zeta Research S.r.l.
Client:
An Italian manufacturer of Medical Devices standing on the international
market.
Client’s aims:
Design and conduct of a clinical study post-market as quickly as possible.
Specific advanced requirements:
Randomized clinical trial
Clinical data to be spent directly for marketing purposes
Urgency to receive analyzed data (6-7 months)
Marketability, traceability and maximum transparency of collected data
Absolute compliance with Good Clinical Practice
Case 4
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Proposed solution:
• Scientific conception and study design of the research project from the
scientific literature and the data of the producer-client
• Drafting the study protocol, CRF and additional documents for the Ethics
Committee
• Recruitment of an investigational center in an extra EU country to maximize
resources and time
• Documentation translation and adaptation to local requirements
• Study conducting according to GCP
• Data analysis and clinical-statistical reporting
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Methods and tools:
• Strong and consolidated partnership in the country
• Adaptation and certified translation into the local language of all the
documentation of the study in accordance with local requirements
• Site recruitement and site training
• Site monitoring
• IEC approval
• Logistical management of experimental products
• Conduct in accordance with GCP
• Remote data management
• Data analysis performed by the internal biostatistician team
• Planning and development of a Clinical and Statistical final report.
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Advantages of conducting a post-market MD clinical trial abroad:
• Clear and essential rules for clinical trials with medical devices
• Direct and clear relationship with regulatory authorities and ethics
committees
• Same approach to ethical and scientific evaluation of the study as in EU
• Qualified and helpful investigators
• Modern and “western” clinical structures (with fast internet connection)
• High flow of patients willing to be involved in a clinical trial
Case 4
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Case 4
ANALISYS AND REPORTING (3 weeks)
Close-out Data analisys Reporting
RUNNING TRIAL (3 months)
Enrolling and follow up visits
START UP (6 weeks)
Site recruitment and negotiation
IEC approval Logistical management of
experimental products
PLANNING (6-8 weeks)
Scientific planning and documents drafting
Review and translation Data collection system
implemntation
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Client’s satisfied aims
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• Optimized timing according to objectives and deadlines
• Scientific and methodological rigor of the collected data, supported by the maximum optimization of resources (30% costs’ reduction)
• Clear and effective reporting in full compliance with the goals set by the client
• Study conducted in accordance with the GCP
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