In 2025, the FDAAA 801 Final Rule introduces tighter timelines, new standardized data fields, stronger reporting compliance, and enhanced penalties for non-compliance on ClinicalTrials.gov. Sponsors, CROs, and investigators must adapt by updating SOPs, auditing data, and meeting faster reporting deadlines.…
As the world adapts to a post-pandemic reality, a new COVID-19 variant emerging in 2025 has sparked renewed concern across global health systems. Despite major advances in vaccination, therapeutics, and public health preparedness, the recent appearance of a novel SARS-CoV-2…
Patients are the heart of all clinical trials ranging from recruitment, retention, protocol adherence, assessments, and safety data, making it necessary to ensure that patients arewell-informed on trial protocol, conduct, and patients’ rights. Various measures are in place such as…
In the United States, The Food and Drug Administration (FDA) regulates and oversees clinical trials of food and dietary supplements and develops various regulations and guidelines for their use. The FDA defines ‘food’ as per the Food, Drug, and Cosmetic…
With a population of approximately 1.4 billion people, healthcare expenditure of 2.6% of the country’s gross domestic product (GDP), and the presence of several multinational pharmaceutical and biopharmaceutical companies in India are some factors that have led to India being…
Explore the dynamic synergy between industry and academia in groundbreaking medical research through Investigator Initiated Trials (IITs) and Proof of Concept Studies. Uncover the collaborative model shaping innovative partnerships, driving advancements at the intersection of industry and academia for transformative…
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.…
Autoimmune disorders comprise several diseases in which the immune system mistakenly attacks and destroys the body’s own healthy cells instead of destroying bacteria and viruses to keep the body healthy. Various factors are implicated in the pathogenesis of autoimmune disorders…
Introduction: Clinical trials are a crucial component of the pharmaceutical and medical research industry, aimed at evaluating the safety and effectiveness of new drugs, treatments, or medical devices before they can be made available to the public. These trials typically…
Clinical trials form the decisions for regulatory approval of drugs and medical devices and as a result are the most important step of a drug development program. In addition to being lengthy and costly, clinical trials involve human subjects and…
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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.