While people often seek dietary supplements, many have concerns regarding their potential benefits, safety, and efficacy. As a result, clinically tested and approved food supplements have a strong market presence. It is important to conduct clinical trials on dietary supplements under Good Clinical Practice (GCP) guidelines to ascertain their potential benefits. Health and diet have […]
Read More →The medical device market has grown significantly in recent years. Recent estimates suggest that the global market for medical devices will reach $612.7 billion by 2025. However, competition is fierce, and medical device companies of all sizes have questions about where and how to register their device. The information in this article was last updated […]
Read More →Although many clinical trial sites wish to use technology, they are concerned about software compliance, particularly regarding 21 CFR Part 11 compliance. Using non-compliant technology can result in audits and tense interactions with the FDA and other regulatory authorities. In order to obtain smoother and quicker approvals from the regulatory authorities, researches need to use […]
Read More →The concept of a “digital clinical trial” means leveraging digital technology to improve patient and sponsor experience in handling clinical trials using digital tools to manage end-to-end clinical trial solutions. Digital clinical trials also improve participant access, engagement, trial-related measurements, and/or interventions, enable concealed randomized intervention allocation and has the potential to transform clinical trials […]
Read More →In recent years, hundreds of clinical trial investigations were performed using stem cell to treat common and life-threatening conditions such as heart disease, Alzheimer’s and diabetes. But till now, the only stem cell-based treatment routinely reviewed and approved by the U.S. FDA is hematopoietic (or blood) stem cell transplantation. The efficacy and safety of stem […]
Read More →The efforts in managing and locating files are becoming tiresome for many clinical research organizations. Electronic Trial Master Files (eTMF) software is becoming necessary for managing clinical trial documentation replacing bulky files. If you are in search of an eTMF, then you need to be aware of many aspects and features you need to look […]
Read More →The barriers between IT industries and the clinical research industry is quickly blurring. Now the software tools are sorting the most difficult management tasks in clinical trials. One such challenging task in clinical trials is patient management and engagement. The patient management software very well manages and executes all patient-related tasks effortlessly. While conducting clinical […]
Read More →Patient-focused drug development is a pragmatic shift in the drug development process incorporating patients’ participation right from the first stage of drug development to the end. Patient-centered drug development now has become the talking point in the clinical research industry. It helps to provide meaningful information from participants to researchers in order to perform research […]
Read More →In clinical studies, Electronic Data Capture (EDC) has become the preferred method to capture key-entered data. EDC systems are becoming cornerstones for research. Hence, choosing an EDC system is a crucial and complex process for drug development. The best EDC system involves collecting and managing data. The goal of EDC system selection is to identify […]
Read More →Virtual clinical trials (VCTs), also known as decentralized clinical trials or remote clinical trials, are conducted remotely by taking advantage of technologies and tools such as telemedicine, electronic consent forms, electronic clinical outcome assessment (eCOA), remote patient monitoring (RPM), apps, wearables, digital biomarker collection, and online engagement platforms. Clinical development in drug development is a […]
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