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ACTELION
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FONDAZIONE MAUGERI
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GIULIANI
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ZAMBON GROUP
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The Case Study
ADJUDICATION, the module
of the C.A.D.P.
web based platform used by the Actelion Pharmaceutical process for the
trial cases submission
This system represents an important instrument for the key phase in
clinical trials, the event management.
Clinical trials many times are driven by the events, and there are no
clear standards for their definition and management, thus often leading
to interpretations and possible bias.
The Adjudication process is the following:
input from different data collecting systems are reviewed by a central
committee(Critical Event Committee - CEC) made of experts that decide
if the received clinical data can be submitted as valid "cases" for the
running clinical trial:
Among the used data collecting systems, there are:
- Interactive Voice Response Services;
- electronic CRF (Clinical Report Forms);
- clinical data from Digital Pen &
Paper technology ;
- Adverse Events database;
- Clinical Images data (ECG, radiology,
etc...);
- Data Clarification Forms database;
- and more databases...
For every specific clinical trial the process plans review
sessions.
The Adjudication system allows a real time
tracking of the review phases and the case submission
to the statistical analysis.
The benefit from a web based management of such an amount
and complexity of data is:
- Reduced Time to confirm;
- tracking of every
single review decision;
- indipendent decision
processes;
- management of huge quantity of data
involved;
- management and tracking of data changing;
- interactive tools such
as generate Charts, view Radiology / CT images with zoom / measure /
contrast features...
All these functionalities are integrated into the C.A.D.P.
platform (Computer Aided Data Processing) developed by GM
Servizi S.r.l. and used by Actelion Pharmaceuticals Ltd for its Data
e Project management of the Clinical Trials lead by the
company every year.
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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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e-crf
