Tag: clinicaltrials

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Early Site & Investigator Engagement In HR⁺/HER2⁻ Breast Cancer Trials: Foundations For Better Trial Design

Early site and investigator engagement are the foundations of effective clinical trial design, ensuring that protocols are both practical and patient-focused. This helps sponsors refine eligibility criteria, diagnostic pathways, and recruitment strategies for any planned trial. This is especially required in Hormone Receptor-Positive (HR⁺)/Human Epidermal Growth Factor Receptor 2-Negative (HER2⁻) metastatic breast cancer, where ever-evolving […]

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Mastering Clinical Operations In Asia-Pacific: Overcoming Challenges With Smart Solutions

Clinical operations in the Asia Pacific are rapidly evolving, driven by increasing regulatory harmonization, diverse patient populations across all therapeutic indications, and the adoption of innovative technologies such as decentralized clinical trial platforms, real-time data capture and analysis tools, and AI-powered site selection systems, making the region a strategic hub for current and upcoming global […]

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Thailand: A Rising Leader in Clinical Research – FSP Model in Thailand

The FSP model in Thailand is rapidly transforming how global clinical trials are conducted by combining local expertise with international best practices. In this model, dedicated teams in Thailand handle specific trial functions, helping sponsors achieve faster approvals, smoother site management, and better patient recruitment. We will discuss this model in detail throughout the article, […]

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Oncology Clinical Trials: Key Operational Challenges & How to Overcome Them?

Oncology clinical trials play a crucial role in addressing the current global cancer crisis, which affects millions of people worldwide. According to the World Health Organization and other research bodies, cancer remains one of the leading causes of death globally. Efforts to combat this disease involve a combination of prevention, early detection, and advanced treatment […]

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Smarter Clinical Trial Management in India: Why the FSP Functional Service Provider (FSP) Model Makes Sense

Clinical Trial Management in India can be exciting, but let us be honest, it is not always easy. Sponsors often run into situations where they need extra support for specific parts of a study, but do not want to hand over the whole project. Sometimes they are looking for local experts, other times they just […]

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Transforming Clinical Trials With AI: Smarter, Faster, & More Efficient Research

Applying AI in clinical trials is no longer a futuristic concept; it’s a practical solution gaining traction across the industry. As clinical trials become increasingly complex—with growing data volumes, escalating costs, and stricter regulatory expectations—AI offers timely support. It is being used to optimize trial design, enhance site and patient selection, identify operational risks early, […]

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Bioavailability (BA) & Bioequivalence (BE) Studies For Nutraceuticals: A Comprehensive Guide

Bioavailability (BA) and Bioequivalence (BE) studies provide the evidence needed to prove consistency, efficacy, and product quality for the nutraceutical products. With the growing demand for science-backed nutraceuticals, demonstrating how well a product is absorbed and performs in the body is becoming essential. While these studies are well-established in pharmaceuticals, applying them to nutraceuticals presents […]

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Japan Clinical Trials: Choosing the Right Sites

Japan is quickly becoming one of the most important countries in Asia for clinical research, not just because of its strong healthcare system and regulatory structure, but also due to its growing focus on innovation and patient-centered studies. But running a successful trial in Japan takes more than just choosing a country; it requires selecting […]

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Key Considerations For Clinical Trials In Rare Diseases

Running a clinical trial for rare diseases is very different from trials in more common conditions. Small patient numbers, limited data, and complicated rules make every part of the process more careful and more creative. Instead of going over the basics, this article focuses on advanced but practical things that experienced sponsors need to think […]

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First-in-Human (FIH) Clinical Trials: Key Considerations for Sponsors

Stepping into a first-in-human (FIH) clinical trial is a defining moment in drug development. It’s when a new drug that’s been years in the making finally transitions from lab bench to bedside. This isn’t about proving efficacy—that comes later. FIH clinical trials are all about safety, tolerability, and understanding how the drug behaves in the […]

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