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Mukhtar Ahmed is Vice President, Product Strategy, Oracle Health Sciences.
Life sciences organizations run a challenging gauntlet when it comes to clinical development.
Life sciences organizations run a challenging gauntlet when it comes to clinical development-balancing rising clinical costs, relentless pressure to speed time to market, increasingly stringent regulatory requirements, and complex safety considerations. Ultimately, the answer to these challenges comes down to collecting, managing, and analyzing data-a process that is complicated by the rapidly increasing volume, velocity, variety, and value of data that is outstripping organizations’ capacity to make effective use of it.
The result? Life sciences organizations continue to grapple with data in a number of ways, including:
The need for better and more universally adopted standards is another persistent issue. Companies continue to struggle with creating a standard data model that can accommodate the many types and sources of data that they require to drive discovery and innovation.
The promise and challenges of data-big and small-were the focus of a lively discussion at a recent Oracle customer advisory forum, where we posed this question to life sciences executives in the room:
If you could have perfection in clinical development, solving your operational and data challenges and providing ideal outcomes, what would it look like? What role would technology play?
The group identified three core qualities of perfection within clinical development:
To achieve the objectives above requires an agile and dynamic technology infrastructure that is standards-based and can readily accommodate multiple types of data-structured and unstructured-from many different internal and external sources. Increasingly, this includes clinical, genomic, patient record, operational, financial, payer, enterprise resource planning, industry benchmark, outcome, social media data, and more.
The platform must also incorporate automated feedback loops to continuously update and refresh the data from all sources. In addition, it must be highly secure to protect from growing threats, scalable to easily handle massive amounts of data, and extensible to remain compliant with global and local regulatory guidelines and mandates.
Life sciences organizations are optimistic about the future as clinical development processes and platforms continue to advance. They see several important benefits on the near horizon:
While perfection in clinical development is certainly a lofty idea, the industry is uniquely poised to make significant and measureable gains in the year ahead when it comes to aggregating, managing, analyzing and, most important, using their data to advance discovery and drive innovation. Let the journey begin!
Mukhtar Ahmed is Global Vice President, Life Sciences Strategy, Oracle Health Sciences