FDA Guidance RWD and RWE
FDA Guidance News To manage tracking of submissions that include real-world data (RWD) and real-world evidence (RWE), the FDA...
TCT 2022 Key Takeaways
TCT 2022 Key Takeaways Stat One understands the industry’s increasing complexity and emphasizes the simplicity of clinical...
CEO: George DeMuth, Statistical Expert
CEO: George DeMuth, Statistical Expert George began his career as a statistician at Burroughs Welcome and went on to...
The Importance of a Biostatistician in Clinical Trials
The Importance of a Biostatistician in Clinical Trials https://www.statonellc.com/wp-content/uploads/The-Importance-of-a-Biostatistician.mp4 Statistical Value Biostatisticians play a crucial role throughout the entire...
Conduct of Clinical Trials During COVID-19
Through control and supervision of medical devices and pharmaceuticals, the FDA plays a crucial role in effectively protecting the...
Understanding FDA Study Data Standards
Understanding FDA Study Data Standards The U.S. Food and Drug Administration (FDA) has study data standards that provide a...
COVID-19: Factors Affecting Conduct of Clinical Trials
COVID-19: Factors Affecting Conduct of Clinical Trials As clinical programs face challenges following the pandemic, companies have continued to...
Critical Factors in the Development Process of Diagnostics
Critical Factors in the Development Process of Diagnostics The medical technology world continues to innovate and develop new products...
Stat One EDC®: Balance
Stat One EDC®: Balance Stat One believes that the choice of a data capture solution can be a crucial...
Stat One CEO: Journal Of Pathology
Stat One CEO: Journal of Pathology CEO of Stat One, LLC, George DeMuth, was an author in the Journal...
U.S. FDA: COVID-19 Update
U.S. FDA: COVID-19 Update The U.S. FDA (Food and Drug Administration) has continuously monitored the ongoing response to the...
Clinical Development Capabilities
Clinical Development Capabilities Stat One is dedicated to providing high-quality services in support of your clinical trials in the...
FDA releases Artificial Intelligence Action Plan
FDA releases Artificial Intelligence Action Plan Overview As the healthcare industry continues to transform through innovative technologies in the...
Stat One: New Office Opening
New StatOne Office Opening Through control and supervision of medical devices and pharmaceuticals, the FDA plays a crucial role...
Important Aspects to Consider When Choosing an EDC System
Important Aspects to Consider When Choosing an EDC System Electronic Data Capture (EDC) is the common data collection approach...
CRO Industry: The Importance of Business Practices and Client Relationships
CRO Industry: The Importance of Business Practices and Client Relationships In a relationship-driven industry, teams at contract research organizations...
Paper: Considerations On The Use Of Adaptive Designs in Clinical Trials
Click on the link below to read this paper highlighting statistical considerations on the use of adaptive designs in...
Challenges and Opportunities in Clinical Trials
Challenges and Opportunities in Clinical Trials Our Chief Business Officer, Jeff Welch, was in San Francisco in early January...
Stat One: A Medical Device Specialty Group
Stat One: A Medical Device Specialty Group Stat One, LLC brings forward more than 25 years of working on...
Traditional Values, New Technologies
Traditional Values, New Technologies Stat One, LLC started the New Year off with much excitement and interest as a...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submitting-documents-using-real-world-data-and-real-world-evidence-fda-drug-and-biological-products
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