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Post-Approval Research

Powerful Post-Approval Operational Strategies for the 21st Century

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  • 03 Nov

Post-approval research studies are vastly different from pre-market studies designed for the registration of a new drug or device. In the white paper "One Size Doesn’t Fit All": Applying an Innovative Mindset to Post-Approval Research, I outline these differences and illustrate why companies ought to leverage strategies, processes, standard operating procedures (SOPs), and technologies that are specifically designed for and more relevant to post-approval research.

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Post-Approval Research: Do You Have What It Takes?

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  • 08 Sep

Investments in post-approval research are rising steadily year on year. Chances are, post-approval research represents a substantial part of your annual budget. But how much of that money is being wasted by conducting post-approval studies in an inappropriate and inefficient manner?

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Explosive Growth in Post-Approval Research Drives Increased Cost and Complexity

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  • 04 Aug

In the 1970s, post-approval studies were rarely performed. The 1980s saw a slight rise when the FDA began to require post-approval research as a condition for the approval of certain drugs. Fast forward to 2014, when a full 13.7% of total R&D costs was spent on conducting post-approval studies. What fueled this explosive growth in post-approval research in such a relatively short period of time? And – critically – what are the ramifications of that growth?

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Necessity and Associated Benefits of Having Post-Approval Specific Technology

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  • 26 Jan

Over the last decade, across the globe, the regulatory landscape has changed considerably, with greater focus and awareness on pharmaceutical products post-approval. Legislation, coupled with public concerns about the safety of marketed drugs and the need to evaluate safety and effectiveness of the marketed products in a real-world setting is forcing many companies to embark on post-approval research.

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Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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