The global contract research organization market value reached $39 billion in 2018 and is expected to exceed $51 billion by 2024. The market is becoming competitive, with large CROs going for acquisitions and mergers to increase the portfolio and reach, whereas small and medium CROs are becoming more prominent with their personalized approach, contact flexibility, […]
Read More →Clinical research professionals and staff members say that one of their biggest challenges in conducting a clinical trial is patient recruitment which is obtaining a sufficient number of participants for a clinical trial. If the clinical research team fails to enroll enough study subjects into a clinical trial, this may, by default, extend the study […]
Read More →Many companies spend a significant amount of cost and manpower on software and data management tools/systems to handle clinical trial activities to build, monitor, and manage clinical trial data. Researchers and CRO utilize many software, web-based applications, and cloud source management tools in various stages of clinical development, and here are some of them Softwares […]
Read More →In 2019, the global generic drugs market reached a value of US$ 367 Billion. with a CAGR of 5.7% during the period 2014-2019. The US generic drug market is foreseen to reach US$ 208.6 Billion by 2025, with a projected CAGR of 10.46% during 2020-2025, according to a report by IMARC Group, The global biosimilars […]
Read More →Regulatory agencies of various countries are providing benefits & regulatory incentives for orphan drugs such as faster approvals, fee concessions, and financial benefits, and many more. These incentives are to support and encourage pharma companies to work upon developing orphan drugs or medical devices for rare diseases. The countries that provide regulatory incentives include the […]
Read More →Orphan drug designation for rare disease qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing, so let’s know more about Orphan drug designation Worldwide orphan drug sales are forecast to grow at a CAGR of 12.3% from 2019 to 2024, which is approximately double […]
Read More →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 […]
Read More →Clinical supply chain teams manage some typical challenges almost every day of their work in handling clinical trial logistics for local or global clinical trials. These include those related to regulatory compliance, temperature control (or, excursions), labeling, actual shipment, or last-mile delivery. These challenges are often compounded multi-fold when clinical trials are related to a […]
Read More →Learning about global regulatory requirements and understanding the pathway for approval can help clinical development teams take their global strategy in the right direction. Sharing expertise from regulatory experts for those who need it. (This article was originally published on LinkedIn). It’s no news that we are now living in an era with a tremendous surge […]
Read More →Rare diseases are rapidly becoming a high priority therapeutic area for our industry. This is needed, especially when fewer than 5% of approx 7,000 rare diseases have drug therapies available, and many of these provide limited benefit. There is also a business case to this, due to a supportive reimbursement environment, particularly in the US. […]
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