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THE BREIN
Biomedical Research Environment
The revolution in clinical trials management
What is THE BREIN (Biomedical Research Environment)
The BREIN (Biomedical Research EnvIroNment) is an environment for the planning, the
advancement, the management and the analysis of clinical trials and biomedical data
registers.
Thorough THE BREIN, Exem makes available a network of human and instrumental
resources whose main characteristics are scalability and modularity.
By THE BREIN, accessible from any on line workstation, is possible to manage, in a
centralized way, the projects and the gathering and monitoring of data.
Indeed researchers and observer doctors can plan and manage clinical trials, gathering
information and processing the results.
THE BREIN, represents not only a context of development but an, an environment for the
optimisation and the simplification of clinical trials management too.
Intended audience:
THE BREIN thanks to its characteristics is suitable for the management of several types of
projects, both of high and low complexity.
Scalability and modularity of THE BREIN make this instrument the ideal partner whether
for single Researcher or for big Scientific Societies, Clinical Institutes, Institutions, etc...
The system enables users to know the costs of the study, even at the planning stage;
costs are related to the complexity of the project and to the services requested.
Exem, thorough THE BREIN, offers several types of services.
The client, within the offer, can choose which services he wants to use,
according to his demands.
THE BREIN’s Areas
The BREIN is a modular environment made of 5 areas.
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 PDA (Protocol Design Area)
 CRFDA (CRF Design Area)
 CDSA (Collection Data System Area)
 EDA (Extrapolation Data Area)
 ADA (Analysis Data Area)
The researcher can decide to use one area or more.
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PDA (Protocol Design Area)
Protocols for clinical trial are designed in this area.
Through the scientific network of Exem Consulting, THE BREIN, if requested by the client,
enables to design and arrange the protocols for clinical trials and data registers.
CRFDA (CRF Design Area)
This area is dedicated to the design and production of CRF.
CRF (Case Report Form) represents an indispensable instrument for the registration of
clinical cases, in view of what is defined in the protocol of the clinical trial.
The CRFD Area enables the development of CRF, through experts and consultants of
Consulting.
CDSA (Collection Data System Area)
This area is dedicated to computerisation of CRF.
THE BREIN is an environment where is possible to:
a) Create a network among the researchers engaged in the clinical trial
b) Fill in the CFRs on line
c) Gather the data automatically
d) Process the results
In view of the CRFs supplied by the client or developed together with the experts of Exem
Consulting, a system aimed at collecting observational data will be designed and
developed.
The design and the realisation will be carried out by a team of IT experts and personnel
competent in clinical protocols.
EDA (Extrapolation Data Area)
In the Extrapolation Data Area, BREIN will provide researchers with data necessary for the
analysis of the study.
All the data will be extracted automatically.
ADA (Analysis Data Area)
If requested by the client, thorough the scientific network of Exem consulting, THE BREIN
is able: to produce a statistical analysis of the collected data and to assist the client in the
publication and data dissemination process
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