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9 Ways Worldwide Optimizes Clinical Development for Your Biotech Growth Journey

Worldwide Clinical Trials

Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. Our consultative approach ensures success by integrating research methodology, regulatory affairs strategy, and clinical operations.

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Psychiatry Clinical Trials: Inclusive, Patient-Centric Approaches for Mental Health Research

XTalks

Another unique challenge in psychiatry trials is the placebo response, which is notably high in mental health research. Rae emphasized the need to empower and enable research sites to accommodate patients rather than patients accommodating study schedules.

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The Power of Personalization Amid the Changing CRO Landscape

Worldwide Clinical Trials

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. What Differentiates Mid-Size CROs?

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IISc researchers find picolinic acid’s broad-spectrum antiviral abilities, scouts for partners in pharma companies

AuroBlog - Aurous Healthcare Clinical Trials blog

Researchers at the Indian Institute of Science (IISc) have found that picolinic acid, a natural compound produced by mammalian cells, can block several disease-causing viruses such as SARS-CoV-2 and influenza A viruses. The Institute is now looking for partners in pharma companies to pursue further clinical development of the findings.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? This new guidance will clearly impact the clinical research field, but how? Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinical development?

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Researchers develop CRISPR-based drug candidate for microbiome targeting

Pharmaceutical Technology

The research team has designed four bacterial viruses which use CRISPR technology to kill the unwanted bacteria precisely. The US Food and Drug Administration has granted fast-track designation to SNIPR001, which is currently in clinical development.

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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

Background on the Grants Program Launched as part of the Orphan Drug Act of 1983, this program aims to encourage research and development of drugs, biologics, medical devices, and medical foods for rare diseases, defined as conditions that affect fewer than 200,000 people in the U.S.