CASE STUDY
The system is used for the logistic and data management of an
international multi-center epidemiological (non-registration)
study.
The study requires no treatment, and its protocol demands one enrollment visit only during which a physiological sample is taken and undergoes a preliminary test at a local laboratory (suggested by the
center) that determines its study eligibility. The sample is then mailed, with international shipment organized centrally for the single
countries, to one main laboratory where the study comparative tests are performed.
In addition to the usual data management issues (also considering that the protocol requires a rather simplified
CRF), the specific study type implies the need to
coordinate and monitor specifically the logistic aspects
linked to the shipments and tracking of the samples sent by each
center.
The system is based on a series of services that are accessible to the different users depending on their
profile/role within the study. Specifically, for the Zambon Group implementation:
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the Sponsor has complete visibility of the system (browsing through all the functionalities)
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the Study Coordinator (C.r.o.)
has complete visibility of the system, has Tracking editing responsibility, manages the fax tracking, and has responsibility of shipment scheduling for the collection of Sample from the centers
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the Data Entry Operators edit the Clinical Data and visualize the Queries
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the Country Coordinators have the function to coordinate the centers of one or more nations, and therefore visualize the information of the centers that are assigned to them by participating
in CRF editing and fax tracking
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the Investigators can register a new patient (by requesting a Patient Number to the system), participate to the fax tracking management and confirm the availability of Samples for vector pick-up
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the Central Laboratory manages the collection of Samples by scheduling their shipment
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the Data Manager downloads the data (totally or by groups) in previously agreed XML format to elaborate them with its own cleaning processes, produces Queries (again in previously agreed upon XML format) and upload them in the system
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the Statistician accesses the system functionalities like a Data Manager to receive the data once the study is finished
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THE
Client
Zambon Group S.p.A. is a
multinational pharmaceutical company located in Italy, composed by consociates, participates and representative offices with
product laboratories in Italy, Switzerland, Brazil, and
China.
Zambon’s history starts in the beginning of the 20th century in Vicenza and continues to our days towards international growth.
Today Zambon is a multinational company whose turnover is primarily made
abroad.
Zambon Group S.p.A’s pharmaceutical branch has ended in 2003 with 9% growth compared with the previous year. |
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numBERS
12 countries
will participate to the study, with a total of approximately
100 centers involved
1,500 patients currently enrolled (with final prospective of
4,500/5,000 patients) |
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MODULES ACTIVATED
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ADMIN, general administration of the system |
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USER,
user profile |
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TRACKING, management of research projects |
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E-CRF, data entry |
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QUERY, data analysis |
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STEERING COMMITTEE, Steering Committees management |
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DATA VIEW DOCUMENTATION, consultation of data collected |
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LABORATORY, visit and analysis management |
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REPORTS, publication of results |
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NOTES
– Administrative management form
It allows the study
administrative manager to set up certain cost
parameters in the system that can be
withdrawn directly from the system, as follows:
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patients with valid Samples and failed patients (costs taxable center by center) |
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check visits and Sample shipments
(average costs) |
Additional fees (investigator's meetings, material, salaries, consulting, various fees, etc...), both estimated and effective, may be entered in order to produce estimates and analyze gaps.
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e-crf
