Any clinical research professionals and staff members say that one of their biggest challenges when conducting a clinical trial is, obtaining a sufficient number of participants.  If the clinical research team fails to enroll enough study subjects into a clinical trial, this may, by default, extend the study timeline, increasing resource usage and costs. A […]

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In recent years there is a huge leap of pharma industry towards rare diseases and orphan drug developments due to the great support from regulatory authorities such as faster approval timelines, supportive regulatory frameworks, financial incentives and many more. Currently, large pharmaceutical companies are extremely active in the orphan drugs market. Novartis, GSK, Roche, and […]

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In a way to support and encourage pharma companies to work upon developing drugs or medical devices in rare disease, several country regulatory agencies are coming up with various benefits such as faster approvals, fee concessions and financial benefits etc. These countries include the US, Europe, Japan, Australia, South Korea and most recently, India. Incentives […]

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Financial benefits, faster approvals and less stringent clinical data requirements are some important benefits that regulatory agencies across the world offer as incentives for development of orphan drugs for rare diseases. These countries include the US, Europe, Japan, Australia, South Korea, Brazil and most recently, India. These incentives have been so supportive and convincingly helpful […]

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Clinical supply chain teams manage some typical challenges almost every day of their work in handling clinical trial logistics for local or global clinical trials. These include those related to regulatory compliance, temperature control (or, excursions), labeling, actual shipment or last mile delivery. These challenges are often compounded multi-fold when clinical trials relate to a […]

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Learning about global regulatory requirements and understanding the pathway for approval can help clinical development teams take their global strategy in the right direction. Sharing expertise from regulatory experts for those who need it. (This article was originally published on LinkedIn). It’s no news that we are now living in an era with tremendous surge of […]

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Rare disease drug development is gaining interest in pharma industries. Large pharmaceutical companies have been working for many years, and now startups, small and mid-range pharma companies are also gaining traction in rare diseases drug development.  Developing medicines or drug products in rare diseases is always challenging for both the scientific and clinical development team […]

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New Zealand could be an interesting choice of region for national and international organisations seeking to pursue clinical research  and looking for most preferred destination in Asia-Pacific Region. New Zealand, a country named third most beautiful country in the world with stunning and diverse natural beauty, jagged mountains, is full of islands with one of Earth’s most […]

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Ukraine, the eighth largest European country by population, has often been overlooked as a clinical trial site, yet remains an attractive location for multinational companies for its clinical studies potential. Ukraine is one of the most attractive regions of the post-Soviet area in terms of clinical research because of its Vast population which is concentrated […]

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Japan is the world’s second-largest single-country pharmaceutical market, accounting for approximately 10 percent of global drug sales and expanding quickly. Top foreign pharmaceutical companies operating in Japan enjoy annual growth rates from 12 to 31 percent, rivaling the expansion observed in emerging markets. This growth spurt has been largely attributed to the Japanese government’s multi-year […]

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