Collating and integrating data from a myriad of sources especially in global clinical trials requires that the data be in an accurate, reliable, and consistent format. The application of standards to data ensures data quality, facilitates exchange between different regulatory…
Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered from them is accurate, reliable, reproducible, and traceable as well…
Data analytics, technology, and accessibility to the internet and healthcare has led to a paradigm shift in the way clinical trials have been conducted. Traditional clinical trials that have been used long since to generate data in support for approval…
The increasing focus and acceptance of real-world data (RWD) in clinical decision making has led regulatory authorities and sponsors to understand its influence on data management that is an integral part of the clinical trial process. The United States Food…