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Data
management and statistical analysis are key elements for the whole process of clinical
and epidemiologic studies: for this reason, since 2001 OPIS increased the Data Management
and Statistical Analysis activities with the set up of a Biometric Department, managed
by Silvia Amigoni and synergically co-ordinated with the historical core of the
company.
Thanks to the strengthening of the organizational structure and to the whole staff’s
expertise and competence, OPIS is also able to offer highly qualified services in
the field of data management and statistical analysis, also for international clinical
and epidemiological studies.
The whole activity of data management and biostatistics is based on ICH guidelines,
on the Sponsor’s specific needs and on Standard Operating Procedures (SOPs
– internal or supplied by our Customers).
Moreover, strict quality control methods are applied along all the study phases.
The
data management system security is ensured by strict rules for access and use, arranged
by user or group of users, by planned backup processes and by suitable protection
against the external world.
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Data Management |
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A
staff dedicated to development and management of the individual trial specific database
is a key element in order to achieve the project goals in the set time.
Data Managers are involved in the CRF design stage and they are specifically responsible
for developing the database of the individual experimentation, for devising the
control systems of the data entered, the notification of the queries, the validation
system and, generally, the quality verification of the data obtained.
Our SOPs ensure a Data Management process that is reliable, accurate and consistent
with the specifications required by the Sponsor.
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Statistics |
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Our
Statisticians’ staff is involved in the process starting from the study design
stage for the definition of objectives, for sample size calculation and for analysis
plan definition. They cooperate closely with the Data Managers in the CRF development,
prepare statistical analysis programmes, produce listings, summary tables and graphs.
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