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The rising impact of biomarkers in early clinical development

Drug Target Review

As biomarkers become increasingly relevant in indicating the workings and effects of novel therapies, their potential as valuable clinical and regulatory endpoints is also gaining recognition. Biomarkers can play a crucial role throughout clinical development, especially in early phases. Bagyinszky E, et al. 21(10):3517.

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How FSP Models Help Biotech Companies Augment Their Clinical Development Needs

PPD

Because biotech companies need to remain flexible and agile while remaining on time and on budget they are harnessing innovations to navigate unexpected drug development challenges and leveraging strategies to fill gaps in resources and expertise. FSP outsourcing is growing faster than FSO.

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Leveraging Remote-Based Regional Hubs to Improve Efficiencies and Meet Timelines

PPD

These hubs support a geographically distributed remote workforce that provides greater stability and project continuity while offering the global expertise and capabilities needed to bolster clinical development success.

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Building the requisite clinical development infrastructure for medical innovation to thrive

Drug Target Review

We have seen how quickly vaccines and treatments can be developed when innovation is prioritised and stakeholders work together against the backdrop of imminent societal needs. Converting these challenges into opportunities, we must embrace new clinical development strategies that promote agility, efficiency and effectiveness.

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Coordinating the Cell Journey: Essentials in Early Clinical Development

PPD

The role of the clinical logistics monitor (CLM) is a focal point of contact and an escalation point to the internal and external teams. Explore our early development services LEARN MORE The post Coordinating the Cell Journey: Essentials in Early Clinical Development appeared first on PPD Inc.

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How the FSP Model Augments Biotech Sponsors’ Internal Capabilities

PPD

Meeting the never-ending challenges of drug development in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinical development functions.

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Navigating Varying Regulatory Feedback in Clinical Oncology Trials: A Guide for Clinical Research Professionals

Conversations in Drug Development Trends

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. For example, there are accelerated pathways for oncology drug approval in the U.S., Japan, and China. and the U.S.