Featured Articles
-
Understanding Various Site Use Cases For eSource And EDC
9/20/2023
Learn how leveraging electronic data capture solutions can be pivotal in ensuring the successful execution of clinical research trials through expedited data processes, minimal errors, and more.
-
Public Perceptions Of Clinical Trials: A Comprehensive Survey
9/20/2023
To gain insight into the public's general perceptions and understanding of clinical research, review the findings from this survey, which encompassed 1,000 randomly selected U.S. residents.
-
Rare Diseases: Expected Boom In Development And Approval
9/20/2023
Delve into the details of the Food and Drug Administration's "Operation Warp Speed for Rare Diseases" initiative and what sites should do to prepare.
-
The Advantages Of Outsourcing IRB And IBC Reviews To One Partner
8/30/2023
To streamline reviews, learn how sponsors can coordinate both IBC and IRB assessments through a vendor offering integrated resources.
-
Mobile Application Considerations For Clinical Trials And Beyond
8/28/2023
Delve into fundamental definitions, navigate through the regulatory landscape, and examine common applications of mobile apps in research.
-
What Sponsors Need To Know About Medicare Coverage Analysis
8/28/2023
Discover ways to bridge the gap between sites and sponsors regarding the Medicare Coverage Analysis (MCA) for industry-sponsored trials to better align expectations on both sides and avoid frustration.
-
Partner Helps Biotech Organization Become Inspection Ready
8/1/2023
Delve into the details of how after receiving proper consulting, this renowned biotech company was able to conduct thorough site inspection readiness activities and receive an accelerated FDA approval.
-
4 Unique Challenges Of Oncology Trials
7/24/2023
Consider these strategies for overcoming the unique characteristics of oncology research and the challenges researchers must confront to enhance the likelihood of successful drug development.
-
IBC Vs. IRB: What's The Difference?
7/24/2023
Learn what separates institutional biosafety committees from institutional review boards and their unique processes for oversight, risk assessments, ethical considerations, and participant risks.
-
Ace Your Next FDA Inspection
7/24/2023
This author provides key insights and guidance to sponsors and sites for mitigating risks and ensuring compliance for a successful U.S. Food and Drug Administration inspection.