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CASE STUDY
Actelion Ltd has been using the C.A.D.P.
(Computer Aided Data Processing) web-based system for several years to manage Data & Project management activities.
Based on the Oracle DB, the system has been entirely developed by GM in close collaboration with the Actelion staff.
Specifically, the Actelion Biometrics division uses the system to track and enter data for dozens of studies per year.
The activated units include advanced functionalities for data management:
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TRACKING,
the management of research projects and respective associated users
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DATA
ENTRY, the entry and editing of acquired data
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QUERIES, the generation and management of data inquiries, after Data Cleaning and Management procedures
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DPP
MANAGEMENT,
Digital Pen & Paper
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NOTES, the comments captured in a digital pen
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DATA VIEW,
the tool to browse clinical data and medical information (images, texts, and documents) available to accounts activated for competence data consulting
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DICTIONARIES,
the standard MEDRA terminology with hierarchical extraction according to the internal approach
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RECONCILIATION,
the final data check with the production of comments
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LABORATORY, the management of medical analyses and visits
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NARRATIVES,
the comments to captured data
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DATA
REVIEW, the periodical data revision with a chance to generate queries
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PROTOCOL
VIOLATION, the management of protocol violations
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ADJUDICATION,
the final definition of adverse events and protocol violations
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USER, the customization of a profile or account
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ADMIN, the general system administration
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REQUEST
NEW ROLE, the management of access requests
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ACTIVATION
REQUEST, the access request for a new online account
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THE
Client
A leader in the market of pharmaceutical biotechnology, Actelion Ltd is a
Swiss multinational present in 17
countries.
Actelion Ltd is the pharmaceutical company that produces Tracleer®, the treatment for pulmonary hypertension, and of Zavesca®, the only approved oral treatment against Gaucher’s disease, a rare metabolism disorder.
Founded in 1997, today Actelion Ltd counts almost a thousand employees. |
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numBerS
About 600 users active on the system
Ongoing studies amount to 70
About 10 studies start every year |
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NOTES
- The Resources Management form
It allows to structure the company’s organization chart adding also visual browsing functionalities and activities management (planning/reporting) for each resource employed on projects.
Each resource is associated with activity planning and reporting functionalities, compatible with company roles and functions.
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e-crf
