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 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
Reduced Safety Reporting Times
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
New Risk Evaluation Reports Help Monitor Events
Electronic File Transfer Saves Time
International Exchange of Safety Results
Challenges
- Keep an efficient and accurate record of any reported side effects or unexpected occurrences during product safety testing, known as adverse events (AEs)
- Replace manual spreadsheets with an integrated management system to enable accurate, duplicate AEs checks and searches, and reduce the risk of human error
- 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
- Integrate AE lists and safety monitoring and test results from separate cases and spreadsheets, so staff can complete detailed searches and automatically generate accurate aggregate reports
Solutions
Oracle Product and Services
- Produced detailed single and aggregate safety reports required by international governments and regulatory authorities in one day rather than two to three days
- Reduced the time it took to produce aggregate reports by 50%, from 30 to 45 days, to 15 to 20 days
- Generated separate risk evaluation reports, which could not be created previously, to compare a component’s AEs with those during a previous period of time to check for any changes
- Created various safety and test reports automatically, which increased accuracy and quality and reduced the risk of human error
- Enabled industry-standard electronic E2B files to be submitted directly from the company to regulatory authorities, which reduced the time and effort it took to produce these files and ensured compliance with national and international industry regulations
- Implemented Oracle Argus Interchange to exchange safety results and test case information electronically with affiliate companies and industry regulators worldwide, starting in mid-2012
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
- Oracle Partner
HCL Technologies
“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.
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