Tag: clinicaltrial

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Partnering With Site Networks In Rare Disease Trials: Why Is It Important For Your Clinical Trials

Partnering with site networks offers a strategic solution to overcome the unique challenges of conducting clinical trials in rare diseases. Limited patient populations, complex recruitment pathways, and the geographic dispersion of expertise often hinder the progress of these trials. By leveraging established relationships, specialized knowledge, and streamlined processes, site networks can enhance trial efficiency, accelerate […]

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Modernizing Clinical Trials: The Role of eTMF, CTMS, and EDC Integration

The integration of Electronic Trial Master File (eTMF), Clinical Trial Management System (CTMS), and Electronic Data Capture (EDC) is transforming how clinical trials are planned, managed, and executed. By connecting these systems, organizations can eliminate data silos, reduce manual errors, and ensure real-time information flow across trial stakeholders. This integration enhances regulatory compliance, improves trial […]

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Beyond The Feasibility Questionnaire: Rethinking Feasibility Assessments In Asia-Pacific Trials

In clinical trials, traditional feasibility is often assessed through a feasibility questionnaire means figuring out if a planned study can run, whether it’s practically possible, ethically sound, and likely to work at the specific site or within the region where it’s proposed. Beyond the feasibility questionnaire, determining if a clinical trial will work is extremely […]

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DCGI Approval In India: A Complete Guide To Drug Regulations, Clinical Trials, & Patient Safety

The Drugs Controller General of India (DCGI) heads the Central Drugs Standard Control Organization (CDSCO), overseeing DCGI approval in India, regulation, and quality standards of drugs and clinical trials. As the national regulatory authority, DCGI ensures patient safety and compliance with the Drugs and Cosmetics Act, 1940. DCGI in the Indian pharmaceutical and medical device […]

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Site Engagement In Clinical Trials: When To Start & How To Utilize?

Site engagement plays a key role in the success of clinical trials. Starting engagement at the right time and managing it well can make the trial process easier and more efficient. Using engagement strategies from the planning stage to post-trial collaboration helps overcome challenges like patient recruitment, ensures compliance, and improves data quality. This approach […]

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Why Global Trials Are Crucial For The Development Of Orphan Drugs

Global trials are critical for developing orphan drugs because they provide the necessary platform to evaluate the safety, efficacy, and overall impact of these therapies on rare disease populations worldwide. Orphan drugs are specifically designed to treat rare diseases and face unique challenges during development, particularly due to the limited number of patients available for […]

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Top 10 Challenges in Nutraceutical Clinical Trials: What You Need to Know

The nutraceutical industry has experienced significant growth in recent years, fueled by rising consumer demand for dietary supplements, functional foods, and natural health products. However, with this expansion comes heightened scrutiny from regulatory bodies, highlighting the challenges in nutraceutical clinical trials as a crucial aspect of successfully bringing new products to market. Unlike pharmaceuticals, nutraceuticals […]

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Top Seven Reasons To Choose Thailand For Your Clinical Trials

Thailand is rapidly emerging as a key player in the global clinical trial landscape, with the market expected to reach USD 3.5 billion by 2027. The country’s strategic location in Southeast Asia provides access to a diverse patient population, essential for robust clinical research. Moreover, Thailand’s healthcare system is well-equipped with state-of-the-art facilities and skilled […]

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Achieving Clinical Trial Success: Effective Techniques For Site Identification And Feasibility

Clinical trial site identification and feasibility are critical components of the clinical trial process. Selecting the right sites and ensuring they are feasible for conducting trials can greatly impact the success and efficiency of clinical trials. The process begins with identifying potential sites that have the appropriate infrastructure, patient population, and experience. The right site […]

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