The pharmaceutical industry is going through significant restructuring. The old business model of investing heavily in the discovery of new active ingredients and then creating chemical compounds to tackle devastating health concerns and diseases that affect millions of people no longer applies. The companies that are succeeding today are smaller, more nimble, and take a multidisciplinary approach. They have agile, collaborative work processes that large companies find difficult to adopt.
At Oracle, we've been working on a solution that brings these capabilities to the Pharma industry, a solution that has been almost 10 years in the making - Oracle Agile Product Lifecycle Management (PLM) for Pharma. As we have done for our other industries, we have invested in designing a specific solution for the Pharma industry that will dramatically reduce costs, simplify the management of complex business networks, and speed solutions to market.
Oracle Agile PLM for Pharma will help you:
Develop the best quality products in the shortest possible time.
Eliminate costly waste and rework with a centralized, secure, & accurate drug record.
Create a secure ecosystem of networked partners to speed innovation & execution.
We've delivered 7 capabilities that make this possible.
Drug development portfolio management: We've enabled you to enforce critical program deliverables and regulatory requirements by improving drug development execution, program management and cross function collaboration.
Comprehensive drug development records: We provide structured drug development records to facilitate the re-use of Common Technical Documents (CTD) by capturing complex multi-dimensional data from material, equipment, process/recipes and analytical methods in one system.
Efficient clinical supply management: We enable you to delivers faster clinical trials by allowing you to easily allocate materials and make equipment reservations as well as enabling you to efficiently and effectively manage recipe variations during the all clinical trials phases.
Faster technology transfer: We facilitate the scale-up to commercial drug production volumes simplifying the analysis of the entire drug product development value chain, from suppliers to materials, equipment and processes.
Integrated quality and risk management: We help you build quality into the development from the beginning a comprehensive enterprise quality management solution that support QbD and other quality programs resulting in faster and more efficient regulatory submissions.
Integrated packaging and label management: We help you improve the regulatory integrity of commercial content by providing a global repository for all packaging components, digital assets and marketing collateral that are linked back to development evidence.
Global product registration: We help you create a single product registry to maintain the content required to support regulatory submissions and product rollout.