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 →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 →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 changes in the regulatory system, Japan has become the largest market for clinical trials in the Asia-Pacific region for both local and global studies, and Japan is now a country of choice in clinical development maps. But still, you need a proper strategy to accelerate the drug development process in Japan. Previously it would […]
Read More →Most errors and technical failures in clinical trials arise due to the improper selection of clinical trial designs. The clinical trial design selection will have a strong impact on the cost and time associated with clinical trials. The expected outcomes shall be thought out and carefully addressed while designing a clinical trial. The selection of […]
Read More →Sourcing or importing the IMPs and their supportive products is a challenging process for many researchers and this is more prominent with the countries like China and Japan where understanding the regulations is difficult due to the language barriers and rapid changing norms for making imports. Many key players in logistics are unclear about the […]
Read More →Getting the study drug at the right time is challenging for any clinical trial, and this is more prominent with multi-regional clinical trials. To import and have the IMPs and ancillaries at the clinical trial sites in time, the sponsors need to have the right people, processes, facilities, and technology in place. Note: This article […]
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