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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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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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The rising impact of biomarkers in early clinical development

Drug Target Review

Investigational products with novel mechanisms of action are also assessed for safety in unique ways, creating complexities that can be more dynamically and effectively monitored using biologically relevant biomarkers. Biomarkers can play a crucial role throughout clinical development, especially in early phases.

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Managing Opportunities and Risks in Generative AI Use for Clinical Research

PPD

Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinical research. These domains are ripe for innovation. Errors jeopardize patient safety, regulatory compliance and trust.

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Navigating Clinical Development Challenges to Advance Idiopathic Pulmonary Fibrosis Treatments

PPD

Prioritizing the idiopathic pulmonary fibrosis patient experience in clinical trials Understanding the patient experience is paramount to the success of idiopathic pulmonary fibrosis clinical development. Even attending their regular clinic visits can be exhausting and stressful. Ready to connect?

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Leveraging AI Solutions for Clinical Trial Efficiencies

PPD

As risks are identified, customized action plans are created and provided to clinical teams to keep studies on track. Modernize resource planning Automating resource demand forecasting for studies using machine learning and inputs from AI-driven solutions helps increase productivity and ensures timely and accurate data. Get in touch.

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Coordinating the Cell Journey: Essentials in Early Clinical Development

PPD

This significance and focus are ever more apparent when the starting cellular material is imperative to drug product success. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.