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Results for tag: "Serious Adverse Event"

U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics - Product Thumbnail Image

U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics

  • Training
  • 60 Minutes
  • United States
What are Serious Adverse Events and How do I Handle These? - Product Thumbnail Image

What are Serious Adverse Events and How do I Handle These?

  • Training
  • 60 Minutes
  • Global
Practical tips to comply and implement the Adverse Event Reporting requirement of the new Dietary Supplement and Nonprescription Drug Consumer Protection Act - Product Thumbnail Image

Practical tips to comply and implement the Adverse Event Reporting requirement of the new Dietary Supplement and Nonprescription Drug Consumer Protection Act

  • Training
  • 60 Minutes
  • Global
Major Changes to Clinical Trials in Europe - The New EU Clinical Trials Regulation - What Can We Expect for Compliance? - Product Thumbnail Image

Major Changes to Clinical Trials in Europe - The New EU Clinical Trials Regulation - What Can We Expect for Compliance?

  • Training
  • 60 Minutes
  • Europe
Major Changes to the EU Clinical Trials Regulation: What is Required for Compliance - Product Thumbnail Image

Major Changes to the EU Clinical Trials Regulation: What is Required for Compliance

  • Training
  • 60 Minutes
  • Europe
Dietary Supplement Adverse Event Reporting and Recordkeeping Requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act - Product Thumbnail Image

Dietary Supplement Adverse Event Reporting and Recordkeeping Requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act

  • Training
  • 60 Minutes
  • Global
Design, Execution, and Management of Medical Device Clinical Trials. Edition No. 1 - Product Thumbnail Image

Design, Execution, and Management of Medical Device Clinical Trials. Edition No. 1

  • Book
  • September 2009
  • 296 Pages
Clinical Trial Project Management - Product Thumbnail Image

Clinical Trial Project Management

  • Book
  • November 2023
  • 8 Results (Page 1 of 1)
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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