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 3Es’
complementary expertise, both medical and computer, allows us to offer a
complete service offer to our customers. For this reason, we can propose
package solution including, the software, hardware and human resources for the
duration of your project.
This chapter particularly addresses the following services: configuration,
installation, follow up and hosting of the INES package. The medical expertise
is perfectly integrated in this offer and is detailed in the activity
“Clinical Research”.
Our offer includes 4 main service levels :
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Hosting
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Professional hosting of web site
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Hardware
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24/24 surveillance
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Optimum security (Access and data)
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Configuration
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Configuration of CRF
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Participant training and/or information
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Installation (on site check and testing)
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Leasing
of software and support vary depending on the number of Investigators,
patients, and the duration of the study. User support is assured by phone or by
e-mail by a person who is involved in the study.
Hosting
of the web site is assured by MATRA GLOBAL NETSERVICES. The choice of a
professional to ensure maximum security of data and availability of solutions
concerning clinical study management.
The chapter « Security » gives more details on the measures taken
to guarantee optimised hosting.
System
exploitation includes user administration and system surveillance using
audit files.
Creating new users, affecting rights and passwords require a rigorous
organisation in accordance with procedures determined at the time of the
configuration of the study.
Study
configuration is a very important stage in establishing the link between
medical and technical know-how. To avoid any deviation from the initial
objective, the configuration of a study is carried out by a Doctor or Data
Manager in charge of the study. This person receives training on the study
protocol if he or she is not the author.
We integrate the particularities of an electronic CRF when drawing up the
protocol. For instance, the possibilities offered by this tool such as multiple
choice fields to allowing concise CRF pages. It is important to avoid pages
that are too long.
Data management checks are defined and validated by our partners before
beginning the study. These checks form a guide that is verified for each data
modification either immediately or slightly afterwards depending on the choice
of the Data Manager.
The INES software can edit the complete set of reports pertaining to the
technical documentation of the study. These reports include a legend of the
different fields, a list of forms and their description, a list of references
and lastly the list of data checks.
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