David BOTTIGIOLI
Head of Site Management
20 years of experience in clinical research, as a study coordinator, project manager, then site manager in various environments: health institutions, private companies, association.
Services and Expertise
Your success : our challenge
"Site management" activities are aimed at any investigator wishing to start or develop a clinical research activity, whatever his or her environment: private practice, public or private health institution, research center in development...
The scope and modalities are defined collectively and adapted to each situation and strategy, in the short, medium and long term. It could be support for the investigator in the context of a clinical study or a more global partnership.
Among the activities that may be entrusted to MEDICAL INITIATIVES are:
Within the framework of a clinical study
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Management of contracts and agreements
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Organizational, logistical and documentary implementation of the study
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Project management, Sponsor-CRO / Investigator interface
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Provision of trained and experienced staff: medical doctors, study nurses, technicians, administrative assistant
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Support for patient enrollment
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Data entry in the CRF
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Sampling and processing of biological samples
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Management / administration of investigational products
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Co-monitoring with Sponsor’s CRAs and subsequent corrective actions
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Study close-out
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Invoicing of the Investigators’ fees to the Sponsor or CRO
Within the framework of global partnership
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Structural and organizational recommendations for starting of a clinincal research activity
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Request for clinical trial site autorisation to the regional public health authorities
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Administrative and financial management
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Human Resources management: recruitment and training
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Communication / Prospecting
The success of our current partnerships with various investigator centers encourages us in our desire to contribute to the development of clinical investigation by promoting the emergence of new investigators.
For a more progressive immersion in clinical research, vacations in the investigation sites our founding association LyREC are offered to medical doctors.