Sponsors, Contract Research Organizations (CROs), and sites have adopted Electronic Data Capture (EDC) systems to carry out both simple and complex clinical trials in all phases of research. Clinical trials are moving toward using EDC software, replacing paper records with electronic records. An Electronic Data Capture (EDC) system, also referred to as an electronic Case […]
Read More →The clinical research landscape is shifting drastically due to an increase in the availability of electronic data allowing researchers to make assessments based on available real-world evidence (RWE) obtained from the analysis of real-world data (RWD). Global regulators are encouraging researchers/drug developers utilize the RWE for submissions. Many regulators are accepting the Real-world evidence (RWE) […]
Read More →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 is also recommended by the regulatory authorities. […]
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 →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 need to ensure that the data submitted to regulatory bodies is definitive from an ethical point and make efficient treatment decisions to ultimately affect patient health. So, for these two reasons, the quality of clinical trial data is crucial, and to achieve this quality data, one needs to have proper data management in […]
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 ensure to generate trustworthy and quality data to gain approval from the regulators for new drugs. Thus, an efficient CDM in a clinical trial is important to advance the drug development process. […]
Read More →