05.12.21 How Is The Shift To Decentralized Trials Impacting Clinical Sites?
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Is clinical development prepared for the paradigm shift caused by COVID-19? The pandemic has forced the industry to reevaluate how to engage with patients and acquire patient data without direct, in-person access. Biopharmaceutical companies, medical device companies, and CROs from around the world were surveyed to explore the impact on clinical trials in this new paradigm and gain insights into their experiences operationalizing trials in a pandemic. Learn more.
Featured Editorial
By Ed Miseta, Chief Editor, Clinical Leader
The emergence of the COVID pandemic in 2019 hit a lot of organizations in the R&D and clinical space by surprise. The companies and organizations that convene stakeholders were no exception. One of those organizations was DIA. When shutdowns began to sweep across the globe in March, DIA’s Global Annual Meeting, which brings together t
By Dhiraj Behl Amity Institute of Pharmacy, Amity University, India, Janine Jamieson, International Pharmaceutical Quality, Sweden, and Harikesh Kalonia, Amity Institute of Pharmacy, Amity University, India
Innovative, integrated delivery devices are useful for vaccines as well as treatments required for cancer, heart disease, multiple sclerosis and many more serious and chronic diseases. Drug-device combination product types include the classic prefilled syringes and pens, auto-injectors, metered-dose inhalers, dry powder inhalers, and increasingly the inclusion of connected software. However, regulation of these products is complex.
Combination products (CP) such as these are governed by two or more different sets of regulations, based on their components and primary mode of action. This can lead to challenges for regulatory authorities to agree on product review jurisdiction and also how to streamline the drug and device requirements according to philosophy, documentation, and t