The Apotex Group: Synergy with Clinical Data Systems
ChallengeThe Apotex Group is the largest, Canadian owned Pharmaceutical Corporation. It produces more than 260 generic pharmaceuticals globally. Apotex used AERS (formerly Eventnet) application for their Adverse Event Reporting system, residing on an outdated client-server environment. With the Oracle purchase of Eventnet, now called Oracle Adverse Event Reporting System or Oracle AERS, the Data Management and Drug Safety departments at Apotex requested an integrated, compliant clinical data environment with the most recent versions of the Oracle Pharmaceutical Application (OPA) suite running on a simple and consistent server structure. All system implementation in Apotex Inc, require a Project Plan managed and executed by internal Information Services and business resources including Project Manager, Technical Team Lead and Business Team Lead and Vendor/Third Party Technical Consultants.
Solution
Upgrade of both the Safety and Thesaurus Management systems (TMS) to its Latest Versions
Apotex hired BioPharm Systems as Third Party Technical Consultants from our successful history together to perform Oracle AERS upgrade BioPharm has developed Apotex specific installation procedure taking into account all subtle details allowing smooth upgrade process. This multiple-steps process involved some obstacles that were successfully overcame by joined effort of BioPharm’s consultant and Apotex team.
Firstly, our Senior DBA assigned to the project upgraded the system and moved all legacy data (3000 adverse event cases) from Event Net to the new system. Through three subsequent upgrades, we’ve got the most recent version of Oracle AERS 4.5 up and running.
The Data Dictionary system, Oracle TMS, was the next major challenge. Because the terms in Data Dictionaries (Who-Drug and MedDRA) must be configured to be used by AERS, the systems had to be integrated. That was solved by creating an Oracle SQL script that mapped all Apotex generic drugs to the Who-Drug dictionary. This step made it possible the proper reporting of adverse events cases to the regulatory bodies.
The process also involved business analysis, custom created scripts and development of a new procedures for the business community moving forward.
Using BioPharm’s validation suite for all three systems (Oracle Clinical, AERS and TMS) and also Apotex’ validation test scripts required for system customization , Apotex’ team has successfully executed Operation Qualification (OQ) test cases to ensure their new environment met 21 CRF part 11 and other regulatory requirements.
Results
A Compliant, Integrated Clinical Environment saving resource time and money
Working with Apotex’ OPA implementation team, we provided them with a fully integrated and compliant clinical data environment, with less maintenance than their prior structure further alleviating resource time and maintenance. Since the project went live, Apotex received additional support from our Help Desk and assigned Senior Consultants to ensure business continuity. The Apotex Groups plans to continue using BioPharm Systems in the future to implement, validate, train and support their associates on the OPA Suite.
