28 Jan 2010: The upgrade of the Oracle Clinical system is considered a strategic improvement for MSOURCE.
It is an important step in the development of professional Data Management services for our
customers and puts MSOURCE in a favourable position to participate in more complex EDC
studies requiring state-of-the-art systems, processes and staff. To support the professional
conduct of EDC studies, the Data Management group has already implemented new SOPs
tailored to EDC studies in particular. MSOURCE builds on experience with over 230 Data
Management projects since 1997 where 50 have used EDC technology.
“Oracle Clinical RDC 4.5.3 offers many advantages as a secure platform for data management in
clinical research including: tailored screens to meet the needs of study sites, CRAs, project
managers and data managers; Rapid navigation to patient CRFs for data entry and review;
Robust system of edit checks; Information-rich discrepancy navigator, presented side-by-side
with CRF, allowing quick resolution of accumulated discrepancies; Role-based, customisable
tasks; Status reports based on the layer of different entities (patient, site, study all via secure Web
access with zero client footprint for the HTML data entry window allowing improved secure global
access and performance; Integrated modules for coding and thesaurus management and a lower
cost base compared to other systems ensuring cost effective customer solutions”, said Hildegard
Weber-Quick (Head of Data Management).
“To further ensure a robust secure platform for customer projects the complete technical
infrastructure is now located and hosted in the central TÜV SÜD AG datacenter in Munich,
MSOURCE’s parent company. This provides customers great confidence to select MSOURCE for
all their data management outsourcing needs”, said Hugo Hartmans (Director, Clinical Data
Management, Statistics and Medical Writing services).