Category: clinical trial

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Rare Diseases: Regulatory Incentives for Development of Orphan Drugs – The United States & Europe

Many regulatory agencies across the world are offering incentives for the development of orphan drugs for rare diseases. These incentives include financial benefits, faster approvals, less stringent clinical data requirements, and many more. The countries that are offering the regulatory incentives for orphan drugs include the US, Europe, Japan, Australia, South Korea, Brazil, and most […]

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Rare Diseases: Patient Recruitment Strategies in Clinical Trials

Patient recruitment in rare disease clinical trials presents several difficulties. These challenges include limited eligible patients, dispersed geographic distribution, low disease awareness, site and investigator identification difficulties, and ethical considerations. They hinder participant enrollment and cause trial completion delays. Over the past few years, the rate of drug development in rare diseases has been increasing. […]

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Rare Diseases: Pre-Clinical Studies And Clinical Trials In Orphan Drug Development

The development of drugs in rare diseases provides great opportunities to pharma companies along with challenges that are required to overcome during drug discovery, pre-clinical, and clinical stages of drug development. Commercially rare diseases drug development differs from traditional diseases, as there are considerably few patients to take the drug, therefore pharmaceutical companies should consider […]

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India is ready for your clinical trials. Are you?

A country with a large pool of patients, highly skilled Investigators, and supportive regulations to promote clinical research is a desired destination for any organization for clinical trials. India has a lot more to offer besides these advantages, enabling you to enjoy the timely completion of clinical trials and cost benefits. (India offers a 35 […]

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