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New data is fueling the drug development pipeline.
October 14, 2014
By: Dr. MaryAnne
Oracle Health Sciences
The potential uses of big data in the life sciences industry continues to explode. Along with the promise of highly precise and effective next-generation therapies, it is revolutionizing collaboration and how strategic partnerships between contract research organizations (CROs) and sponsors are formed and managed. These partnerships are increasingly moving to the forefront as organizations work to effectively leverage this wealth of new data and improve analytics to feed the drug development pipeline and most importantly improve patient healthcare outcomes. While ripe with potential, the creation of new partnerships does not automatically ensure success. Unless carefully crafted and supported, they can simply proliferate data silos without increasing the collaboration and transparency needed to make the most of big data. Instead, partnerships need to be carefully crafted and supported with infrastructures that enable effective and secure data sharing, collaboration, and analysis. CROs that play an active role in this process position themselves for competitive advantage. Keeping Pace with Changing Requirements The last two decades have yielded tremendous transformation in clinical development requirements and approaches. This becomes quite clear when one looks at the characteristics that have defined development programs in the last part of the 20th century versus today. Historically, clinical trial programs have been characterized by: Unsustainable costs; enormous amounts of under-utilized data; massive logistical exercises; and limited insight into possible outcomes. Things are changing rapidly, fueled, in part, by economic requirements as well as the advent of big data. More than ever, the industry needs more efficient practices, research, and tools to harness the full benefits of personal health and healthcare-related data. Today’s environment, by contrast, features: Fewer patients enrolling in clinical trials; focus on cost-control/value derived; quest for intelligence-based decisions; and more predictable outcomes. In this era of constrained resources, greater complexity and data proliferation, organizations that choose to go it alone are at a significant disadvantage. As such, we see traditional sponsor-CRO relationships giving way to the need for new strategic innovation partnerships—a cross collaboration between a variety of stakeholders including pharma, CROs, academic research, business process services (BPS) consulting organizations, and technology companies. Partnerships Yield Strategies for Patient Centered Outcomes Strategic innovation partnerships, in which CROs are positioned to play a pivotal role, can enable new levels of collaboration that accelerate innovation and discovery, improve clinical development productivity and control costs and risks. Together, CROs-Sponsored-Technology Organizations are actively working together in driving an approach towards personalized healthcare given the changes in healthcare, reimbursement, reform, meaningful use of electronic health care data, and patient-centered outcome mandate. The goal is to establish more big data driven approaches towards personalized healthcare, and demonstrate its applicability to patient-centered outcomes and meaningful use. By creating these partnerships and collaborations between various stakeholders, the industry expands access to the resources needed to navigate and optimize use of big data. With the need to drive new analytics solutions and robust infrastructures that can handle the volume, variety, and velocity of clinical and healthcare data, intelligent partnerships are also in demand to collectively translate the information into meaningful value to generate results rapidly. The promise of big data is to provide insights to discover and predict faster, simplify access to all data and gain insights, and govern and secure all data. Build a Partnership Foundation for Success Productive strategic innovation partnerships do not happen in a vacuum. They require an infrastructure to support communication, collaboration, transparency and insight. CROs are uniquely positioned to play a central role in creating these infrastructures. Over the years, CROs have become highly specialized by therapeutic area, clinical phase and geographic locations in managing thousands of clinical trials. Their niche clinical expertise includes managing the evolution of volume, velocity and variety of data on behalf of sponsors. With complexity and scalability at an all time high, CROs are best positioned to partner with sponsors on how to harness and leverage big data for making decisions about clinical trial planning. Pharmaceutical sponsor companies have improved their collaboration by identifying data elements to share with their identified strategic CRO Partners. There is a real opportunity for sponsors to engage CROs much earlier in the clinical trial planning process. The wealth of new data and enhanced analytics can strengthen partnerships between these Sponsor-CRO-Technology organizations to intelligently approach clinical trial planning and execution and streamline the drug development process. Changing requirements drive the need for new types of strategic partnerships in the health sciences industry. CROs that plan carefully and can deliver the infrastructure and support that these partnerships require can benefit in several important ways. They are positioned to help their partners drive new levels of insight and clinical productivity that accelerate innovation, while distinguishing their organizations in an increasingly competitive industry.
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