Results for tag: "Serious Adverse Event"

Serious Adverse Events (SAEs) are any untoward medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in persistent or significant disability/incapacity, or are a congenital anomaly/birth defect in clinical trials. SAEs are monitored and reported to regulatory authorities to ensure the safety of trial participants. SAE reporting is a critical component of clinical trials, as it helps to identify potential safety issues with a drug or device. Companies must ensure that SAEs are reported in a timely manner and that the data is accurate and complete. Companies must also ensure that SAEs are tracked and monitored throughout the trial to ensure that any safety issues are identified and addressed. Companies in the Serious Adverse Event market include Oracle Health Sciences, Medidata Solutions, eClinical Solutions, and Bioclinica. Show Less Read more