Revised Chinese regulations that brought a lot of changes in clinical trials and product registrations were received with lots of questions. If you have got questions that are yet unanswered, you are not alone. Many researchers, developers, and managers are not sure about one aspect or another on how to comprehend, act, or change their […]

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Do you know any product segment, where one does not get to encounter Chinese products? Well, hardly any. It has been the focus of the Chinese government for the past several decades to dominate various industrial sectors, including pharmaceuticals. While China has been the big production factory for generic drugs and API ingredients for many […]

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China has brought significant reforms in its regulatory system for pharmaceutical industry and clinical trials. In its continuous drive to improve the system, recently China‚Äôs Food and Drug Administration (CFDA) announced a major overhaul of its medical device regulations as well. To the current regulations, China has made significant changes. Summarily, 12 articles were newly […]

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The number of clinical trials for rare diseases is increasing drastically from the last ten years to more than 500 as compared to a few hundred clinical trials. Currently, more than 400 orphan designated drugs are commercially available, and around 1000 drugs are undergoing clinical trials. Drug development in rare diseases is often challenging and […]

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Oncology trials are considered to be more complicated than trials in any other therapeutic area. The research in oncology differs in the trial design, type of trial, the role of a comparator, treatment outcomes, adverse events reporting, interpreting the results, etc. The growth in the global oncology market is moving at a rapid pace. In […]

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Do you know, according to clinicaltrials.gov, a total of 354,130 clinical trials were registered worldwide with 71,256 ongoing clinical trials as recorded on Oct-2020? The number of clinical trials is increasing year by year from 56.16k in 2017 to 60.69k in 2018. In the USA, more than 2.3+ million people participate in approximately 80,000+ clinical […]

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Clinical trials in rare diseases are more challenging than clinical trials in more frequent diseases for many factors such as the trial design, the number of patient populations available for recruitment, require regulatory support, etc. Applying a perfect clinical development strategy may help in overcoming these challenges and accelerate the drug development process in Orphan […]

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Drug development is a lengthy, complex, and costly process, entrenched with a high degree of uncertainty that a drug will actually succeed and reach the market successfully. Drug development is the process of bringing a new pharmaceutical drug or a medical device or a treatment procedure to the market. Many developers often lack a clear […]

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Do you have scientifically proven evidence that the country you have chosen is a perfect destination to conduct your clinical trial? Does the country you have chosen provide all the resources for conducting your clinical trials?  Have you compared it with other eligible regions? The US and most Western European countries remain the important centers […]

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