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Managing the process of ethical submission and approval of the study, development of data collection tools, data management, monitoring ,for a premarket Pediatric Medical Device (class II) trial.
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CRO4QContract Research Organization
Best practice
Copyright © 2013 Zeta Research S.r.l.
Case 3: Ethical documentation, data and site
management
• Randomized pediatric pre-market trial on Medical Device
2Copyright © 2013 Zeta Research S.r.l.
Copyright © 2013 Zeta Research S.r.l.
Client:Medical Devices producer with an international distribution network.
Client’s aims:Managing the process of ethical submission and approval of the study, development of data collection tools, data management, monitoring ,for a pre-market Pediatric Medical Device (class II) trial.
Specific advanced requirements: Clinical protocol revision Drafting of documents for the Ethical Commitee Initiation site visit Site file Monitoring Project management
Case 3
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Copyright © 2013 Zeta Research S.r.l.
Proposed solution:
• Methodological and statistical review of the research project from a draft of the clinical trial protocol
• Preparation of a technical report on the product based on available technical, scientific and pre-clinical data
• Ethical documentation drafting and management• Management of the process of submission to IEC until approval• Writing ad-hoc e-CRF (Electronic Case Report Form) optimized
following the end points• Initiation site visit, investigators’ training• Monitoring visits with senior monitor (according to legal
requirements)• Final statistical analysis and reporting
Case 3
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Methods and tools:
• Scientific literature research and review and pre-clinical and clinical data analysis for the protocol protocol and technical report writing
• Drafting of documents for the Ethical Commitee• Management of the process of submission to IEC until approval• Projecting and implementazion of a web-based data collection
system (online) for e-CRF (according to legal requirements)• Implementation of a system IWRS (Interactive Web Response
System) to manage randomization, unblinding, device deficiency, adverse event recording
Case 3
Copyright © 2013 Zeta Research S.r.l. 5
Copyright © 2013 Zeta Research S.r.l.
Methods and tools:
• Training on protocol, experimental device and data collection tools for investigators
• Site monitoring: initiation site visit, monitoring and study closure performed by Senior Monitor in possession of all the legal requirements
• Drafting of all documentation to be included in the Site File available to the authorities
• Project management to support the Centre and its activities, and to interface with the Promoter
• Data analysis performed by the internal biostatistician team• Planning and writing of the Clinical and Statistical final report • Full compliance to Good Clinical Practice and to the ISO 14155
Case3
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Copyright © 2013 Zeta Research S.r.l.
Client’s satisfied aims
Case 3
•Added value derived from the Project Management: assistance and support to the Centre for operational and organizational needs in the start up phase of the study
• Optimization of the internal resources of the client.
•Clear reporting and effective in full compliance with the goals set by the client.
•Ready-to-spend data according to the client’s scientific and market objectives.
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