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.

1. CRO4Q
Contract Research Organization
Best practice
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2. Case 3:
Ethical documentation, data and site management
• Randomized pediatric pre-market trial on Medical Device
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3. 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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4. 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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5. 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
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6. 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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7. 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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