Tag: clinicaltrials

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The Brivaracetam Generic Opportunity: Patent Status, Market Dynamics, and Bioequivalence Study Design

Brivaracetam, commercially available as Briviact®, is an established antiepileptic medication approved for focal epilepsy management. It is used in conjunction with other medications to help control seizures. This drug is designed to offer pharmacologic differentiation from levetiracetam, including higher SV2A affinity and improved tolerability in select patients. Major patents for Briviact® are set to expire […]

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Preparing for Post-Patent Generic Launch: A Practical Guide to Bioequivalence Studies

When patents for Reference Listed Drugs (RLDs) expire, it opens the door for generic manufacturers to offer more affordable alternatives to brand-name drugs. However, successful entry into the market requires careful preparation ahead of the patent expiration. To demonstrate that a generic drug is equivalent to its branded counterpart, companies conduct thorough clinical research. This […]

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Choosing the Right Country for Your Clinical Trials in Complex Therapeutic Diseases: Why Investigator and Site Perspectives Count?

Choosing the right country for a clinical trial, particularly in complex therapeutic diseases, is a difficult task due to its reliance on factors that databases and standard metrics cannot fully measure. When therapies involve advanced technologies like modified immune cells or genetic interventions, the analysis must extend beyond basic feasibility. It requires examining site capabilities […]

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How to Supply Laboratory Kits to Clinical Trial Sites in Japan: A Step-by-Step Guide for Sponsors and CROs

Japan has one of the most tightly regulated pharmaceutical landscapes, which necessitates a seamless supply of laboratory kits (for clinical trials) to its sites. The process requires strict adherence to the guidelines of the Pharmaceuticals and Medical Devices Agency (PMDA). For sponsors and CROs, this raises the question of how to supply laboratory kits to […]

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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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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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Clinical Trials For Implantable Medical Devices: An Overview of Gastric Cancer

Clinical trials for implantable medical devices are transforming cancer care by making therapies more targeted, less toxic, and, eventually, more effective. From drug-eluting stents and intratumoral drug delivery devices to implantable pumps, biodegradable implants, ablation probes, and biosensors, these advancements are transforming cancer care. They are intended to administer therapies exactly where most needed, while […]

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Planning Clinical Trials In Japan? Here’s How To Ship Your Ancillaries & Non-IMPs

If you’re planning a clinical trial in Japan, one of the most important (and often overlooked) aspects is how to properly ship your ancillary supplies and non-IMPs. In particular, lab kits, diagnostic devices, and other materials may be required. Therefore, navigating import requirements is not always straightforward. With strict regulations and detailed customs procedures, a […]

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