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 →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 →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 →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 →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 →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. […]
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