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EU Orphan Drug Designation – overcoming regulatory challenges

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Preparing for the New Era of Hybrid Regulatory Inspections

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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8 things you need to know about eCTDs in China

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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Maintaining Data Integrity for Quality and Compliance – Essential Despite Pandemic Disruptions

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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New FDA Guidance Addresses the Need for Data-Generation Strategies Across the Drug Development Lifecycle

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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How to better prepare patients for a cell or gene therapy trial

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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Communicating Value to Providers and Payers

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Early planning can help you make the most of expedited regulatory pathways

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Getting to ‘No’ fast is more important when you are small

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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How biotechs can strengthen their value story with advanced analytics

Read five ways biotech companies can enhance their value story with advanced analytics.

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Want to run a patient-centric rare disease trial? Be site-centric

Patient and site-centricity go hand-in-hand.

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Pragmatic Trials: Targeting evidence generation to inform market access and meet payers’ needs

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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New endpoints for early-stage cancer are gaining regulatory traction

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Five lessons for building an external control arm that regulators can use

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Episode 17: Funding Biotech Innovation: How to Attract Investors

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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How emerging biotechs can enter the Chinese market and prosper

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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Making Expedited Regulatory Pathways Work for Global Drug Development Programs

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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Biotech Showcase: Fireside Chat with Jamie Macdonald

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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Three strategies for articulating a coherent product value story

Articulating a coherent product value story from the start of development can help companies attract investors.

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Master Protocol Trials: What Are the Elements of Success?

The shortcomings of traditional study designs have come into sharp relief during the COVID-19 pandemic. Regulatory agencies and the research community alike have responded, acknowledging the need...

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