Do you know according to clinicaltrials.gov a total of 354,130 clinical trials were registered worldwide with 71,256 ongoing trials as recorded on Oct-2020? The number of trials being conducted is increasing year by year from 56.16k in 2017 to 60.69k in 2018. In the US 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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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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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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This article is a sequence of United States: Drug Approval Regulatory Process Part-I which describes the Investigational New Drug (IND) approval process, New Drug Approval (NDA), and Generic drug approval process. In this article, we will discuss the marketing approval process of Biologics, Biosimilars, Orphan drugs, and various approval pathways. Which is the regulatory authority for biologics […]

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The U.S. represents the largest continental pharma market worldwide and holds around 45% of the global market The US pharmaceutical market is projected to increase from $354bn in 2015 to $497bn by 2020, according to a report. Though markets like china and Indian have shown a great leap in the pharma market, the United States […]

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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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Most of the companies are spending a significant amount of cost and manpower to manage clinical trial activities as database building, monitoring and management of data using a variety of EDC systems as Inform, Rave, Oracle Clinical Remote Data Capture, Veracity, etc. Many software, web-based applications, and cloud source management tools are being used in […]

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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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