Panacea Biotec Cuts Aggregate Reporting Times by 50%, Complies with Pharmaceutical Industry Regulations
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Oracle Customer: Panacea Biotec
Location: New Delhi, India
Industry: Life Sciences
Employees: 3,800
Annual Revenue: $100 to $500 Million
Panacea Biotec is a research-based health management company
based in New Delhi, India. The company researches, manufactures, and
sells branded pharmaceutical formulations, vaccines, and natural
remedies, including prescription products for pain management, diabetes,
cardiovascular health, renal disease management, osteoporosis, and
gastro-intestinal care.
Panacea Biotec has manufacturing plants
in Baddi, Delhi, and Lalru, and research and development centers in
Delhi, Lalru, Mohali, and Mumbai. The company employs around 3,800
employees in India—including 300 scientists—and has affiliates in
Germany, Switzerland, the United Arab Emirates, and the U.S. It has
filed more than 1,200 patent applications and holds 382 product patents,
which are valid in 68 countries.
Panacea Biotec subjects all its
products to rigorous safety testing. As the company tests the various
pharmaceutical product components, it keeps a record of any reported
side effects and unexpected occurrences that may or may not be directly
associated with the product, such as an adverse reaction following an
immunization. These are known as adverse events (AEs). The event is
checked against a list of known AEs associated with the component, and
if the AE is occurring for the first time, it is added to the list and
flagged as suspect.
The company traditionally used spreadsheets
to record listed and new AEs during safety monitoring. However, it was
becoming difficult to perform the necessary duplicate AE checks and
searches, and because a number of staff within the safety department had
access to the spreadsheets, there was a high risk of human error. As it
became harder to manage the data, it also became more difficult to
generate accurate reports detailing listed AEs, which are required by
international governments and regulatory authorities, such as the
European Medicines Agency and the U.S. Food and Drug Administration.
Panacea
Biotec needed a comprehensive management system to integrate AE data,
complete detailed searches, and produce accurate regulatory reports. In
July 2010, the company engaged Oracle Partner HCL Technologies to
implement Oracle Argus Safety and Oracle Argus Interchange.
“As a
pharmaceutical manufacturer and researcher, it is vital that we report
adverse events that result from the use of our products to comply with
competent authority regulations,” said Dr. Mudgal Kothekar, deputy
general manager, pharmacovigilance, Panacea Biotec. “Oracle Argus Safety
is an organized, manageable application that enables our staff to
easily perform duplicate searches, raise automated queries, and validate
data about adverse events to ensure the safety of our products
A word from Panacea Biotec
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“As a pharmaceutical manufacturer and researcher, it is vital
that we report adverse events that result from the use of our products,
to comply with competent [compliance?] authority regulations. Oracle
Argus Safety is an organized, manageable application that enables our
staff to easily perform duplicate searches, raise automated queries, and
validate data about adverse events to ensure the safety of our
products.” – Dr. Mudgal Kothekar, Deputy General Manager,
Pharmacovigilance, Panacea Biotec
Why Oracle
Panacea Biotec evaluated several other companies offering
pharmaceutical industry-standard software, but decided on Oracle as it
proved more cost-effective and user-friendly.
Oracle has a
strong reputation in India and Panacea Biotec was impressed by Oracle’s
established partner network. The company’s staff also had experience
with Oracle Argus Safety and other AE management systems in previous
roles and felt that Oracle Argus Safety best met the company’s needs, by
offering a more comprehensive system that would support the end-to-end
pharmacovigilance program.
Implementation Process
Panacea Biotec engaged Oracle Partner HCL Technologies to
implement Oracle Argus Safety and Oracle Argus Interchange in July 2010.
HCL migrated data from Panacea Biotec’s development,
validation, and production environments in four stages, addressing
several issues encountered in the initial migration from the development
platform to ensure the same problems were not encountered in the
subsequent data migrations.
Oracle Argus Safety went live in December 2010. The company plans to go live with Oracle Argus Interchange in mid-2012.
Partner
HCL Technologies spent almost five months working onsite with
Panacea Biotec to implement Oracle Argus Safety and ensure the
pharmacovigilance management system was tested thoroughly before going
live.
“To ensure we effectively helped Panacea Biotec improve its
business processes and adopt new technology to conform to industry
regulations, we carried out a careful evaluation of its current system,
data usage, and technical data,” said Alamelu Balaji Ganesh, associate
project consultant, HCL Technologies. “We created a detailed data
migration strategy and worked closely with Panacea Biotec to resolve any
issues and ensure it could easily generate reports.”
HCL carried
out four data migrations and ensured problems encountered in the first
instance were addressed before the second migration. The partner also
helped Panacea Biotec create the required regulatory, aggregate, and E2B
electronic reports.
HCL carefully planned the go-live approach
to avoid any last minute surprises and offered Panacea Biotec advice and
support throughout this crucial time. After the system went live, HCL
provided training to staff in Panacea Biotec’s pharmacovigilance
division and offered remote support for four months until employees were
completely comfortable with the system.
