The development of digital clinical trials has completely altered every aspect of our lives. One of the sectors with the most room for innovation is the health sector. However, the clinical research sector has been sluggish to accept digital clinical trials and integrate the digital tools that hold the secret to safer, more effective treatments […]

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Over the past years, the number of conferences and publications devoted to decentralized and digital clinical trials has skyrocketed in the pharmaceutical research sector. Nearly every clinical research company has joined the conversation, fuelled by the global pandemic. Conferences are there almost weekly to discuss methods and equipment for transferring laboratory-based research to clinical settings. […]

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A clinical trial’s outcome depends on several variables, but one of the most important is patient recruitment. Ineffective trial recruitment strategies can cause late-stage trials to be delayed by roughly 11 months, increasing operational costs and extending time to market. Clinical trial recruiting strategies begin with the patient in mind and include a range of […]

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Clinical research is a field that can be difficult in and of itself, so it is essential to understand the knowledge and skill requirements for the various roles. A healthcare professional that oversees various duties for clinical trials and other kinds of medical research is a clinical research associate (CRA) The CRA is responsible for […]

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You must ensure the participation of a clinical biostatistician for the benefit of the clinical trial and team members because they are crucial in biostatistics for clinical trials. For instance, it is essential to understand how to derive the components used in the analysis and assumption of the resulting data.  The statistician’s role is critical […]

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Although people seek dietary supplements, many are concerned about the potential benefits, safety, and results. Therefore, clinically tested and approved food supplements have a good market. We should conduct clinical trials on food supplements under Good Clinical Practice (GCP) to determine the potential benefits of dietary supplements. Health and diet have received more attention since […]

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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 […]

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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 […]

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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 […]

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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 […]

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