The US FDA recommends efficient clinical trial design strategies to expedite the development of oncology drugs and biologics. FDA also provides guidance and advice to sponsors of drugs and biologics for cancer treatment regarding the design and conduct of clinical trials, other than first-in-human (FIH) trials. In contrast to traditional trial designs, where a single […]

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To make a clinical trial faster, less costly, and more successful it all starts with strategically designing a clinical trial. The sturdy trial design is essential to ensure a successful clinical outcome. A proper study design determines the fate of the clinical trials and their likeliness to be successful as it involves many deciding parameters […]

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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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Drug development is a process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. The drug development process starts from drug discovery to getting market approval and post-marketing studies. This entire process of medical device/drug development takes years and completely depends on […]

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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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Many people with rare diseases struggle to find the right diagnosis and right treatment for years. The lack of awareness about these conditions make it much harder for them to get the right treatment. Rare Disease Day is all about raising awareness for rare diseases. And, this year, you can join these efforts too. The […]

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Cost and time for clinical development constitute more than 70% of total development of any drug! Small – mid scale biopharma are known for their innovative approaches, agility and faster developments. However, clinical development has always been one step too important, yet too hard for them. There are ways to overcome these challenges and optimize […]

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Increased outsourcing is seen in pharmaceutical and biotechnology companies, with 85 percent of the clinical segment. The global CRO market was estimated at $31.6 billion in 2018 and was expected to reach $45.2 billion by 2022, according to a report. What is a CRO? Contract research organizations (CRO) are the companies that provide support to […]

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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 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 years, […]

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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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