EU Orphan Drug Designation – overcoming regulatory challenges
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The FDA has strengthened its use of remote inspection and integrate desk-based assessments with traditional on-site visits. This outlines what you need to know about this new era of hybrid inspections
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Although eCTDs are a huge step forward for standardization in the Asia Pacific, there are several important things you need to know before you submit your dossier electronically.
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While COVID-19 disrupted business operations, the importance of data integrity in manufacturing has not diminished. How can sponsors reconcile the adaptations they made during the emergency?
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David Brown, Global Head of Epidemiology, summarizes the three FDA guidances related to data sources, data standards, and regulatory considerations in RWE/RWD and benefits of early engagement.
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Parexel spoke with Doug Olson, Cancer survivor and CAR T-cell patient, about how healthcare providers and trial sponsors can better communicate with patients about CGTs.
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Drug development is a complex business. Historically, less than 8% of product candidates are reported to have made it from Phase I to market. One effective way to mitigate risk is to weed out weak...
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Read five ways biotech companies can enhance their value story with advanced analytics.
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Patient and site-centricity go hand-in-hand.
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For payment systems to evolve to deal with reimbursement and market access challenges, payers are taking a new look at evidence generation and data usage. Read how pragmatic trials can help >
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The biotech industry posted record financing, deals, and M&A numbers in 2020 and 2021, spurred in part by the swift and successful development of COVID-19 vaccines. Despite this favorable funding...
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In this article, Parexel experts outline five approaches that foreign companies with limited resources should use to gain a foothold in the Chinese market.
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Article from December 2021 edition of Applied Clinical Trials. Parexel regulatory experts offer top tips for working with regulators on a global scale.
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Parexel CEO, Jamie Macdonald, discusses how the pandemic accelerated and changed the industry, and emerging industry trends driving growth in 2022
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Articulating a coherent product value story from the start of development can help companies attract investors.
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