The dynamic pharmaceutical, biotech and life-science sectors are constantly evolving. With frequent mergers, acquisitions, competitive pressures and the need to meet stringent regulation, companies operating in this arena need to be able to analyze and streamline core business processes - as well as deliver corporate and regulatory governance to the highest standards, say Jeff Fraleigh, US senior vice president and Eileen Cairo, senior consultant at Casewise, in a contributed article for The Pharma Letter.
The pharma sector is synonymous with innovation, but there is a general sense that these organizations often don’t have their “houses in order” when it comes to the adoption of efficient processes, communication and reporting tools. Indeed, many still rely on out-dated methods to support areas like R&D manufacturing, clinical trials, sales and marketing activities.
This is especially true at a time when the pharma sector is undergoing an acquisitory revolution – of both rival companies and products. There is also a huge effort to document processes and procedures so that traceability is kept high on the agenda. This is no ordinary filing job; pharma companies are now under more pressure than ever to ensure traceability in order to comply with regulatory bodies such as the US Food and Drug Administration, the Health Insurance Portability and Accountability Act (HIPAA) and the UK Data Protection Act Data Commissioner.
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