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Biotech Resources

Browse our Biotech resources to find the latest articles, blogs, brochures, and videos from our experts. See the latest content below.

Parexel Biotech

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Synthetic Control Arm Case Study

Synthetic Control Arm Case Study

1st ever comparator cohort study submitted for regulatory submission and labeling of product

Previous Flipbook

Expedited Pathways Comparisons - US EU CHN

Slides presented during virtual roundtable, entitled "Making expedited regulatory pathways work for global drug development programs"
Next Flipbook

IMP shortage Case study

Ensuring continuity of supply to patients despite IMP shortage

Most Recent Flipbooks

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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Overview of China's Market Approval Policy Med Insurance Payment System

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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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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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To create more rare disease drugs learn from the past

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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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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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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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Meet the team flyer

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Case Study Marketing Authorization Transfer

Learn how one client gained several efficiencies in their complex Marketing Authorization Transfer project.

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Case Study Lifecycle maintenance

Learn how our integrated support and round-the-clock publishing saved valuable in-house resources for one client.

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China eCTDs Things you need to know

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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Global similarities and differences of eCTDs

Submitting electronic dossiers is not the same in every country, in some cases their are several commonalities but also several differences.

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Part 2 - Preparing for our risk-based future: Using change management to drive RBQM adoption

In a two-part series, this second paper discusses driving RBQM adoption and what an effective RBQM change management program looks like.

Read More
Expedited Pathways Comparisons - US EU CHN

Slides presented during virtual roundtable, entitled "Making expedited regulatory pathways work for global drug development programs"

Read More
IMP shortage Case study

Ensuring continuity of supply to patients despite IMP shortage

Read More

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