Clinical biostatistics play a crucial role in the drug development process right from trial design to protocol development. Biostatistics finds applications in various fields such as epidemiology, clinical trials, population genetics, systems biology, and more. Biostatistics is critical to collect, analyse, present, and interpret data in clinical research. it helps in making decisions regarding the […]
Read More →An electronic informed consent (eConsent or eICF) is a principle in clinical research that a patient should have sufficient information before making their own free decisions about their medical care and participate in clinical research. Using electronic medium to manage informed consents makes the researchers job easy and regulatory authorities also recommend using eICF. Did […]
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 eTMF (Electronic Trial Master File) plays a crucial role in clinical trials and ensures that the trial has been managed successfully by the sponsor, investigators, and the Institution. Regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) developed initiatives to use technology that could help both expedite the […]
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 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)? […]
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