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Founded
in 1998 by Aldo Poli and Laura Ambrosoli, OPIS has grown through a process of internal
development based on the will to offer highly specialized services, ensuring maximum
flexibility and availability to meet our Customers’ needs, always in compliance
with Good Clinical Practice (GCP) values and with Standard Operating Procedures
(SOPs – internal and supplied by the Customers).
Since 2001 a Biometric Department was implemented, and thanks to this OPIS is in
a position to offer highly professional Data Management and Biostatistics services,
which represent a real “buttonhole flower” in clinical trial management.
Today, OPIS employs 115 people, most with a degree in Scientific Subjects (Medicine
and Surgery, Chemistry and Pharmaceutical technology, Biology, Pharmacy, Statistics).
All our employees are recruited on the basis of personal and and aptitude characteristics,
according to strict selection criteria, aimed at searching for the employee’s
maximum motivation and professional satisfaction and for the optimization of the
quality level offered to the Sponsor in the individual activities. Moreover, for
all the positions regular training courses are scheduled in accordance with what
written in internal SOPs.
The essential organizational policy, mirrored both at a group level and at each
operational unit level, is of giving maximum value to competences: specialization
as a support to quality, focalization for the benefit of maximum efficiency.
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Quality Management
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Since
its foundation, OPIS has given great importance to quality management, considering
it critical for the internal quality development and for the continuous improvement
of the services offered to its Customers.
The Quality Manager is in charge of CRAs training, supports them in co-monitoring
visits, checks that all the research activities are carried out in compliance with
GCP, prepares the Investigational sites in case of audits, and sees to the generation
of new SOPs and to the periodical updating of the existing ones.
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General Affairs & Logistics |
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The General Affairs & Logistics unit is actualy made up of three people, under the Managing Director supervision; this last one is
responsible of all the activity related to management of information security, Managing support, and administration of facilities and
logistics.
The managing of Privacy, the attention on personnel screening and training, the Italian safety set of rules and the development
of a operative inner communication system are the goals of this Unit, taking care on inner and uoter customer satisfaction in Business
Development.
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Information Technology
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The
IT group is responsible to assure the effective function and
use of the Oracle Clinical System program.
- He provides a support to Database Administrator and Data Managers as long as it
regards the use of the system and educational trainings for the specific functions
of the system.
- Also helps the Database Administrator to setup the clinic database and to develop
validation procedure for clinical data.
- Identifies system function problems and provides the operative solutions, if necessary
integrates on-line or phone supplier support.
- The IT group also involved into developing the contacts for
clinical study management.
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