CASE STUDY
HP Digital Pen&Paper technology has been
integrated into the web based system of Data Management
C.A.D.P.
in order to simplify and accelerate the compilation activities of the
CRF.
There are currently 12 official clinical trials Phase III and IIIB/IV
(observational e interventional, multicenters) running on this new technology. Their duration range is from 12 months up to 4 years with about 3000 planned patients. Some of these clinical trials have a complex CRF including patient's questionnaires and Operability Evaluation Forms.
Previously the CRF were compiled using traditional pen and paper with the disadvantage that the data was not available in real time to the various monitors, accepting a considerable loss, especially in terms of time.
The functionality of the integrated system involved 2 distinct areas: the visualization/management of the data coming from the digital pen (which uses the web platform exclusively) and the printing of the CRF (which is active both on the web and on the server).
Most problems that have been confronted and resolved had to do with the integration of the Data Management system and of the FAS technology with all of the activities of production, digitalization and printing already part of the Actelion reality.
Another not indifferent factor to confront was the optimization of the acquisition phase of a large mass of data, including the
additional pages.
GM provided Actelion, in addition, with all of the corollary instruments for the management of the studies: from management of
logistical problems to the control of possible errors to providing a round-the-clock
help desk.
The activated profiles:
| _ |
the Monitor
has full visibility of all the pages created
|
| _ |
the Investigator
uses the Digital Pen for sending the completed CRF, visualizes the data sent and respective reports
|
| _ |
the Data Entry
Coordinator manages the functionality of printing
|
|
 |
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. |
|
numBERS
12 activated studies
About 3.000 planned patients are foreseen in the activated studies
About 700 patients currently managed in the 12 active trials |
|
THE
ACTIVATED MODULES
| _ |
PRINTER
MANAGING,
the compilation of printing requests |
| _ |
VIEWER,
the visualization of the CRF entered |
| _ |
REPORT,
the statistics of the data entered |
| _ |
ADDITIONAL
PAGES, the management of the more voluminous sections of the CRF |
| _ |
ADMINISTRATION,
definition and layout of forms |
|
|
|
e-crf
