D&O Clinical Research Organization becomes
first in India to implement Oracle Clinical
Oracle Clinical creates a huge opportunity for
Clinical Data Management in India
Mumbai, September 16, 2004
- Oracle India Private Ltd today announced that D&O Clinical
Research Organization, a strong player in the emerging market of Clinical
Data Management in India has successfully implemented Oracle Clinical.
This is the first major win in this segment for Oracle India.
The clinical trial phase is the most complex
part of the life sciences product cycle - and in order to reduce time
to market, it is critical that companies shorten it. Tracking adverse
events and eliminating redundancy in the process of remote data capture
are challenges that players in this space have to meet. Companies are
also faced with strict regulatory requirements that require detailed records
and the efficient handling of huge volumes of data.
Oracle India helped D&O use Oracle Clinical,
a part of Oracle E-Business Suite, to meet these requirements. As a result,
D&O has been able to compress the cycle for clinical data compilation
and open up a new area of business.
Speaking on this occasion, Mr Girish Virkar,
CEO, D&O Clinical Research Organization said, "Oracle has ensured
that the clinical data management software is fully compliant with 21CRF
Part11 guidelines. This is essential to ensure that the data captured
in the database is thoroughly auditable. Oracle Clinical maintains audit
trail of the entire sequence of events in clinical data management and
ensures that the study can be reconstructed with the log of activities.
Second, it provides timely service support. This is very critical when
a project requires any technical support; the vendor should be available
to solve the problems immediately. These benefits made us choose Oracle
over other vendors."
"Oracle Clinical is a powerful, comprehensive
clinical data management solution which allows companies to standardize
and control data definitions and data usage across a global operation,
ensuring that data is defined, managed, and interpreted consistently worldwide.
This expedites the multinational regulatory approval process and reduces
cycle times in critical clinical trial processes, thereby accelerating
time to market for new products" added Mr Ram Varanasi, General Manager
- Sales, Oracle India Pvt Ltd.
About D&O
D&O is a well-established Contract Research Organization conducting
R&D, Custom Synthesis for more than a decade. D&O's strength lies
in its four R&D units, one affiliated analytical lab and cGMP Pilot
Plant in India. D&O essentially caters to the requirements of multinational
pharmaceutical companies across the globe. Last year D&O expanded
its activity by diversifying into Clinical Research Field. This diversification
will cater services like Clinical Trials, Data Management and Bio-statistics
to Indian and global customers. For more information please visit www.dnogroup.com
About Oracle India
Oracle India Private Ltd. a wholly owned subsidiary of Oracle Corporation,
the world's largest enterprise software company, has been operating in
India for more than a decade. Oracle was one of the first international
software companies to set up an India Development Centre in 1994. Today,
Oracle's two India Development Centers, at Bangalore and Hyderabad, work
closely with Oracle's global software development team, headquartered
at Redwood Shores, California, on the entire Oracle product family. India
is also a hub for several of Oracle's global support, consulting and financial
services operations. Through its offices in Delhi, Bangalore, Kolkata,
Chennai, Hyderabad, Mumbai, and Gurgaon, and an extensive network of more
than 150 channel and alliance partners under the Oracle PartnerNetwork,
Oracle India markets the complete range of Oracle products and services
across India. Oracle database is supported on 13 major Indian languages.
Oracle India has more than 6,250 customers in the telecommunications,
banking, insurance, manufacturing and utilities industries, in both the
government and private sectors.
About
Oracle
Oracle is the world's largest enterprise software company. For more information
about Oracle visit our Web site at http://www.oracle.com
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