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What’s next for clinical data management and investments?
January 29, 2015
By: Rick Morrison
Chief Executive Officer, Comprehend
It’s that time of the year again. A time to reflect on what we’ve accomplished and to set our strategies for the year ahead. As technology has shown remarkable advancements across many industries over the past year, we’ll look to the future to see how innovations will drive changes in the life science space. Smaller sponsors will surge Big pharma companies are no longer the sole drivers of innovation and blockbuster drugs, but now rely on buying smaller biotechs to enhance their pipelines. We are starting to see more of the smaller and mid-sized sponsors stay independent and focused on what they do best, which is innovative R&D. This specialization is made possible by leveraging top specialized CROs, technology, modern processes and approaches. Mergers and acquisitions will continue, but the stakes will be higher as these small and mid-size pharmas can go the whole way themselves. The CRO “hierarchy” will flip The CRO market is due for a significant shake up. More and more sponsors are demanding better access to their data throughout the course of their trials, a practice divergent from the way things were always done. CROs that are able to evolve to incorporate emerging technology will be the most successful. The repackaging of existing services won’t cut it as drug developers are looking for outsourcing partners that support new and more effective ways of bringing treatments to market. Today’s market leaders are at risk of falling to competitors that are more modern and take on new approaches to clinical development. The shift has begun to move from prominent service-based CROs to those that are solution-based. Electronic data collection is becoming commoditized Although electronic data collection (EDC) has been a game changing development for life sciences over the past decade, we have just begun to scratch the surface and researchers are demanding quicker results. The introduction of EDC more than a decade ago made huge advancements in terms of the quality and speed of data collection, but it was still rooted in simply copying legacy methods electronically. EDC has failed to deliver on its full promise. In the year ahead, we’ll see more sponsors focused on reinventing clinical development, which means investment in better analytics and data access to enable novel approaches like risk-based monitoring, adaptive trials, cross-study insights and identifying potential threats to data and trial integrity. Handling the genome Genomic sequencing will continue to drive significant opportunities in personalized medicine and rare disease. While the benefits of this revolutionary research offer great promise, the scope, complexity and sheer volume of these new data sets pose enormous challenges in data management and analysis. It will become increasingly important to implement the kinds of next-gen, cloud-based technologies designed specifically to handle huge data sets, and enable cost-effective and streamlined data delivery and management. Efficient solutions designed to manage big clinical data are critical to more informed decision-making and improved strategic management that will lead to better science and much needed therapies. Genomics analysis and management is extremely complex, and the growth in related data sets has already outpaced storage capacity, but the promise is so large that innovation is inevitable. mHealth will move beyond fitness apps Most can agree that the consumerization of health initiatives is beneficial for the general population. New products like Apple HealthKit and Nike FuelBand have the ability to incent patients to become more involved in their overall care. But as we arm patients with devices to track their steps or count their calories, we should make sure we’re working to solve the much bigger problems in healthcare. We must continue to find ways to marry patient data with clinical data so that we can maximize the benefit of clinical research for the patients. We should remain focused on bringing data together to solve larger issues such as making clinical trials more efficient, effective and more tailored to the individual. Technology adoption will continue to shift towards new business models, especially as the need to rein in costs, streamline operations and adhere to regulatory guidelines increase pressure on clinical development. By using technology as a driver, we can fuel new business processes and overcome the challenges inherent in complex drug development.
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