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How FSP Models Help Biotech Companies Augment Their Clinical Development Needs

PPD

Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinical development needs.

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The AI model that is changing clinical trial design

Drug Target Review

Clinical trials are expensive, slow and often limited by outdated design constraints. They offer patient-specific outcome predictions, generated using machine learning models trained on real historical clinical data. Accelerating timelines and de-risking development decisions across the pipeline.”

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The rising impact of biomarkers in early clinical development

Drug Target Review

Advanced strategies and tools are being implemented to establish the safety and efficacy of new therapeutic modalities, with the development of new biomarkers becoming one of the most relevant approaches for enhancing the precision and utility of early-stage studies.

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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog: Drug Discovery

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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How Japan and South Korea are Shaping the Next Era of Clinical Development

Fierce BioTech

How Japan and South Korea are Shaping the Next Era of Clinical Development Discover why Japan and South Korea are emerging as clinical trial powerhouses, offering cutting-edge infrastructure, streamlined regulations, and unique commercial advantages. CMIC Group Resource Type Whitepaper CMIC_ListingLogo_250x190.png

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AI in drug discovery: faster, smarter, better

Drug Target Review

It involves a dynamic and often unpredictable process where every stage, from target identification to clinical trials, generates vast amounts of data. Additionally, AI-driven predictive modelling can shorten the preclinical phase by simulating biological responses, leading to more targeted and efficient clinical trials.

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Why Including Patients in FDA Engagement Will Benefit Your Trial

Conversations in Drug Development Trends

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

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