Published on March 20, 2014
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 2Copyright © 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 Copyright © 2013 Zeta Research S.r.l. 3
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 Case 4 Copyright © 2013 Zeta Research S.r.l. 4
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. Case 4 Copyright © 2013 Zeta Research S.r.l. 5
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 Copyright © 2013 Zeta Research S.r.l. 6
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 Copyright © 2013 Zeta Research S.r.l. 7
Client’s satisfied aims Case 4 • 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 Copyright © 2013 Zeta Research S.r.l. 8
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