In the ever-advancing field of pharmaceutical development, regulations surrounding drug clinical trials in the United States serve a critical purpose. These frameworks are not merely bureaucratic hurdles; they exist to safeguard public health, ensure the scientific credibility of research, and…
The transition of a drug, medical device, or biopharmaceutical from the laboratory bench to bedside involves a long series of steps starting from drug discovery, computational chemistry, in vitro and ex vivo studies, preclinical and in vivo animal studies that…
Despite advancements in digitization and remote or decentralized trials, traditional clinical trials with a central site, in-person recruitment and monitoring, and paper-based or electronic regulatory submissions continue to remain critical for the approval of new drugs, medical devices, and biologicals.…
What Is Post-Marketing Surveillance? Post-marketing surveillance (PMS) is the ongoing assessment of the safety, quality, and effectiveness of drugs, biological products, or medical devices after they have been authorized for use by the public. It is sometimes referred to as…
Clinical Research Organizations (CROs) are companies that provide support to the pharmaceutical and biotech industries by managing various aspects of the drug development process and conducting clinical trials. In this article, we’ll explore what CROs do and why they are…
The first image that comes to mind when one thinks of where safety and efficacy data for a new treatment is generated is a randomized controlled trial (RCT) at a central site. Although RCTs remain the gold standard for evidence…
Due to COVID-19 vaccine and treatment developments, clinical trials have been in the limelight lately. Before reaching patients, every medical intervention (from common cold pills to specialized cancer drugs) must pass through clinical trial phases. But what are the phases…
The technologies we use on a daily basis – from search engines to streaming music services – recognize patterns in our behaviors and, coupled with vast amounts of data from millions of other individuals, make predictions of what each of…
In the Drug Development process, clinical research plays a key role because the approval from the FDA requires clinical trials to signify the safety and efficacy of pharmaceutical products. Clinical research helps in grasping and applying knowledge for products or…
India has always been a hot destination to conduct clinical trials. Many key factors of doing clinical research in India, make it a worthy place. It’s very logical for sponsors who are interested in selling their products to India’s 1.25…
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ProRelix Research is the rapidly growing Contract/ Clinical Research Organization (CRO) with multi-country service capability supporting phase 1, 2, 3, & 4 clinical trials of Pharma, Biotech, Biopharma, Medical Device, Nutraceutical & Herbal companies to conduct in the USA, India, Europe & South East Asia.