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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For the approximately 7,000 known rare diseases, less than 10% of diseases have an FDA-approved treatment available. Due to a small number of patients, limited understanding of the variability and progression of the diseases, developing a drug or treatment for rare diseases is often challenging. Rare diseases currently affect 3.5% – 5.9% of the worldwide […]

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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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Small and mid-size CROs occupy about 44% of the market share of outsourced development works, approximately. These CROs are gaining interest and becoming the choice for startups, small and mid-sized pharmaceutical and biological companies. While, in the first part of this article series on “Contract Research Organizations For Your Clinical Trials“, the top 10 CROs […]

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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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The global contract research organization market value reached $39 billion in 2018 and is expected to exceed $51 billion by 2024. The market is becoming competitive with large CROs going for acquisitions and mergers to increase the portfolio and reach, whereas small and medium CROs are becoming more prominent with their personalized approach, contact flexibility, […]

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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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