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 is […]
Read More →CROs, biotechnology, and pharmaceutical companies use software to facilitate clinical trials from design to finish. Clinical trial management software includes eTMF, Clinical Data Management (CDM), eConsent, Patient Management, Electronic Data Capture (EDC), Protocol management, CRF design, and many more. The importance of this software in the new era of clinical development is increasing day by […]
Read More →The Medical Device Control Division (MDCO) from the office of the Food and Drug Administration (FDA) in Thailand (also known as the Thai FDA) oversees Medical device regulations. Recently the Thai FDA has made many changes in regulatory requirements and the approval process for medical devices. This article was last updated in March, 2023. Medical […]
Read More →Covid 19 has caused severe disruptions for many people. According to WHO, as of 31 December 2020, COVID-19 had infected over 82 million people and killed more than 1.8 million worldwide. This pandemic raised the interest of many researchers to find the drug and treatment plans for COVID-19. So, now it’s interesting to know the […]
Read More →Drug developers should ensure that the data submitted to regulatory bodies is definitive from an ethical point of view. It helps to make efficient treatment decisions and ultimately affects patient health. For this, the quality of clinical trial data is crucial. To achieve this quality data, researchers need to have proper data management in clinical […]
Read More →Dermatology clinical trials present many challenges to researchers over clinical trials in other therapeutic areas. These include finding perfect clinical trial sites, patient recruitment, patient retention, etc. These challenges are more prominent in rare skin diseases. Dermatology is the branch of medicine which deals with the skin. Dermatologists diagnose diseases related to skin, hair, nails, […]
Read More →The product feasibility study is a scientific assessment process that helps mitigate the chances of product failure. It also helps efficient strategic planning to save costs and time during product development. Product feasibility is a broad-spectrum study that includes market feasibility, geography feasibility, competitive assessments, product viability analysis, etc. What is product feasibility? A feasibility […]
Read More →The development of new drugs is becoming more expensive and needs infrastructure and efficient resources so, licensing collaborations are becoming a favorable option for many global pharmaceutical companies. These licensing options help companies offset to research and development investments and bypass the cumbersome innovation and development process. As per the global data, in the pharmaceutical […]
Read More →Clinical data management (CDM) is a critical tool that helps to generate high-quality, reliable, and statistically sound data from clinical trials. Drug companies produce reliable data to win regulatory approval for new medications. Therefore, for a clinical trial to advance the drug development process, an effective CDM is essential. What is Clinical Data Management (CDM)? […]
Read More →After the initiation of universal health care for their citizens in 2014 by the Indonesian government, the growth of the medical devices market improved and led to the rise in medical devices import. Medical device registration in Indonesia is a relatively fast and inexpensive process, particularly considering the size of the country. Highlights of Indonesia […]
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