planning and management of a clinical trial abroad

CRO4Q Contract Research Organization

Best practice

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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

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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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