| A pharmaceutical
company streamlines clinical drug trial information
by implementing OPM suite and Oracle Financials
from CTE |
This
customer develops pharmaceutical products
based on advanced (inhalable and injectable)
time release drug delivery systems. They
have developed delivery systems for drugs
that address medical disorders including
schizophrenia, alcoholism, growth disorders,
and diabetes.
Challenges
Of all drug candidates selected
for development in the pharmaceutical industry,
few make it to clinical trials. Fewer still
go on to become successful and profitable
products. With the odds stacked against
them, pharmaceutical companies are now refining
their business objectives to maximize their
probability of success. In short, they must
innovate faster, reduce risk, and increase
profitability. Companies in the life sciences
industry are under intense pressure to increase
productivity and make research and development
(R&D) more efficient. Companies face
discovery and development cycles that often
total 7 to 10 years, as well as development
costs approaching US$800 million for each
new drug. What’s more, costs are outpacing
revenue from new products. In the last ten
years, pharmaceutical spending on R&D
has gone up 44 percent, but the number of
blockbuster product launches has decreased
by only 25 percent.
Solution
To ensure public health, federal regulations
require all manufacturers to maintain secure
and auditable trails of information pertaining
to every phase of the development and manufacturing
process. A framework that complies with
the FDA’s 21 CFR Part 11 and cGMP
regulations governing electronic records
and e-signatures is built into the Oracle E-Business
Suite.
For this multi-site pharmaceutical manufacturer,
the implementation and upgrade activity
took place in a fully-validated environment
and included:
 |
Upgrade of corporate
facility from older release of Oracle
Financials and OPM and documentation
for Sarbannes-Oxley compliance audit.
|
 |
New implementation
of Oracle OPM at the main manufacturing
facility
CTE provided the business scripts as
input for Operational Qualification
(OQ)
|
| Benefits |
 |
Reduced risk |
 |
Faster time to
market |
 |
Increased productivity |
|
For more information, please visit www.ctepl.com
or e-mail us at info@ctepl.com. |