FDA Validation Rules for Submission Data are essential for regulatory compliance. Learn about FDA data submission requirements, validator rules, study data standardization plans, and Pinnacle 21 validation. Stay updated with the latest FDA Technical Conformance Guide 2024 to avoid costly…
Clinical trials are necessary in advancing medical research and health care options by allowing new treatments to be introduced in the market through safety and efficacy testing in humans. Successful completion of drug synthesis and combinatorial chemistry/high-throughput screening approaches culminates…
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…
Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered from them is accurate, reliable, reproducible, and traceable as well…
The United States Food and Drug Administration (FDA) has strict regulations regarding pharmacovigilance activities that are a part of post-marketing studies for drugs and medical devices that are required as part of a New Drug Application (NDA). The Code of…
The growing impetus for the conduct of clinical trials outside the United States for products and medical devices intended to be used in the US include multiple reasons such as increased accessibility to patient populations particularly in case of rare…
Clinical trials are critical for the approval of new drugs and medical devices necessitating that data that is derived from them to make regulatory decisions is done so in a manner that generates accurate and reliable data. Thus, clinical data…
Software as a Medical Device (SaMD) refers to a class of medical software intended to be used for medical purposes or that is designed to carry out medical functions without the need for actual hardware. This can comprise of software…
Although the United States Food and Drug Administration (FDA) has always supported and advocated the idea of decentralized trials, the real adoption and application of decentralized aspects in trials has exponentially increased in the recent years due to travel restrictions,…
As per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is recognized in…
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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.