Translation plays a crucial role in facilitating accurate communication between participants, researchers, and sponsors in conducting clinical trials on a global scale. This can be a challenging task, especially when language barriers come into play. Clinical trials are critical for developing new drugs, medical devices, and treatments. These trials aim to test the safety, efficacy, […]
Read More →We use Standard Operating Procedures (SOPs) – uniformly written instructions with thorough explanations – to document common tasks, procedures, and organizational practices. SOPs in clinical research define the group’s standard practices and daily research procedures to ensure that we carry out research tasks in compliance with institutional, state, and federal guidelines. We should create SOPs […]
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 →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 →Designing clinical trials in psychiatry is challenging compared to a regular clinical trial. Clinicians and instructors have to handle participants who are mentally ill. They have to assume numerous factors before the clinical trial, where the main issue is taking informed consent, populations, measuring end-points, etc. There are many ethical laws and criteria for designing […]
Read More →The protection of human rights is paramount in clinical trials, and one should design and implement clinical research ethically and scientifically. Clinical trial monitoring is essential for quality assurance to ensure the protection of human rights and the reliability and transparency of the data collection process. What is clinical trial monitoring? Clinical trial monitoring the […]
Read More →Clinical trials in rare diseases are more challenging than clinical trials in more frequent diseases for many factors such as the trial design, the number of patient populations available for recruitment, regulatory support, etc. Applying a perfect strategy for clinical development in rare diseases may help overcome these challenges and accelerate the drug development process […]
Read More →Many people with rare diseases struggle to find the right diagnosis and right treatment for years. The lack of awareness about these conditions makes it much harder for them to get the right treatment. Rare Disease Day is all about raising awareness for rare diseases. And, this year, you can join these efforts too. The […]
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