Category: clinical trial

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Top 5 Challenges for Shipping Clinical Trial Materials to Japan: How Sponsors and CROs Can Overcome Them

Shipping clinical trial materials, such as ancillaries, medical devices, or Investigational Medicinal Products (IMPs), to Japan requires a thorough understanding of the laws and local regulatory systems. Understanding the challenges for shipping clinical trial materials to Japan begins with recognizing how the country’s regulatory framework differs from most others.  Japan’s clinical trial regulations differ from […]

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Conducting Clinical Trials on Traditional Medicine in the Asia-Pacific Region: Opportunities and Advantages

The Asia-Pacific region is home to a diverse array of traditional medicinal practices. The region is also rich in a large and diverse population. This diversity includes genetic variations, dietary patterns, environmental factors, and disease profiles, which makes trial results more applicable across global populations. Moreover, the growth of research facilities presents opportunities for sponsors […]

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Nutraceutical Clinical Trials: India as a Growing Hub

India is emerging rapidly as a global research and development hub for nutraceuticals. The country conducts nutraceutical clinical trials at lower costs while ensuring that the quality meets international standards. Nutraceutical clinical studies in India follow a regulated pathway, requiring approvals from both an Ethics Committee and the Central Drugs Standard Control Organization (CDSCO). It […]

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Navigating Budget Challenges in Clinical Trials: Practical Strategies for Cost Management

Effective cost management serves as a way to overcome budget challenges in clinical trials. A proper understanding of the key cost factors that emerge throughout the study lifecycle helps to mitigate such challenges. Factors such as patient recruitment, regulatory compliance, site management, and data collection each contribute significantly to the total expenditure. When the cost […]

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Ophthalmology Trials: Managing Protocol Deviations in Visual Function Assessments

Protocol deviations for Visual Function Assessments (VFAs) in ophthalmology trials can affect the accuracy and reliability of outcomes. A VFA measures an individual’s functional or practical visual capabilities. This is in contrast to a standard eye exam, which includes a series of tests to measure real-world visual skills. VFAs perform both quantitative and qualitative assessments […]

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Accelerating Clinical Trials: The Market Advantage of Early Engagement

In the drug development process, delaying the launch of a successful drug can result in lost sales. Early engagement to kickstart the clinical phase plays a key role in accelerating clinical trials and ultimately increasing revenue by providing earlier market access before competitors. Moreover, being the first to market a drug remains crucial for companies […]

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Early Engagement In Site Selection Strategies: Ensuring Investigator Commitment & Trial Start-Up Acceleration

Early engagement in site selection relies on the involvement of high-performing investigators from the start. Every successful clinical trial requires an investigator who believes in the study and a site that feels committed to it. Even groundbreaking studies may stall without dedicated sites and investigators, forcing patients to wait and timelines to be exceeded. Early […]

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Blinded Monitoring In Thailand’s Clinical Trials: Specific Use Cases & Value For Sponsors

Blinded monitoring is the process of reviewing trial data without knowing who is receiving the actual therapy and who is receiving the control. This maintains the review process impartial, fair, and reliable. It reassures sponsors that trial findings are robust enough to meet international regulatory standards. In Thailand, where many clinical trials are large and […]

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Blinded Vs. Unblinded Clinical Study In Oncology: Overcoming Bias, Safety Challenges, & Regulatory Demands

One of the primary concerns when considering a clinical study in oncology is how to ensure that the findings are reliable, objective, and acceptable to the regulators. The solution usually involves blinding, and eventually, when necessary, unblinding. Blinding limits the possibility of bias by keeping patients and researchers unaware of the treatment they receive or […]

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Global Post-Marketing Study (PMS) For Type 2 Diabetes Mellitus (T2DM)/Hypertension

A global post-marketing study (PMS) is required to assess the long-term safety and efficacy of treatments across therapeutic areas. Two of the most prevalent and interrelated chronic diseases worldwide include type 2 diabetes mellitus (T2DM) and hypertension. When combined, type 2 diabetes and hypertension significantly increase cardiovascular morbidity and death, requiring ongoing pharmaceutical treatment and […]

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