CRO
Decentralized Clinical Trials and Regulatory Changes
We discuss the evolution of decentralized trial modalities and possible solutions to regulatory challenges.
2023 Trends
In this podcast, we discuss our predictions and perspectives on the 2023 clinical research trends.
Embracing Changes to the Clinical Research Workforce
In this episode, we discuss workforce challenges in the clinical research industry and the impact of the great resignation.
My Favorite Case Study: COVID-19 Applications for Monkeypox
How the COVID-19 pandemic has shaped vaccine development, promoting accelerated research for conditions like monkeypox.
Beginner’s Guide to IRB Review of IVD Research
If an investigational in vitro diagnostic (IVD) device is used in clinical research, it may require IRB review.
Data on the go: Mobile Application Considerations for Clinical Trials and Beyond
Find out the necessary regulatory and ethical considerations when utilizing an app or connected device in human subjects research.
Privacy and Confidentiality in the Age of Mobile Apps and Connected Devices
Discover how to protect participant privacy in mobile-app-based clinical research. Learn about risks and what IRBs need to consider in protocol review.
How Single IRB Review Mandates Help Research Sponsors
The proposed single IRB mandates will impact FDA-regulated research, potentially altering existing practices at organizations.
Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Interpreting evolving regulations for medical devices is a common challenge for emerging biotech companies.
FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
FDA recently released new guidance, potentially impacting early-phase cell and gene therapy trials.
Diving into Single IRB Implementation
In this episode, we get an inside look at how institutions implement sIRB requirements and how to overcome potential challenges.
Sickle Cell Disease: The Importance of Amplifying Patient Voices
Sickle cell disease significantly impacts the African American population, a minority community historically underserved by clinical research.
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