4 Modernized Functions Every Sponsor Needs for Study Startup
This white paper outlines four technology capabilities sponsors need to expedite the study startup process.
Collaborating with Research Sites: Best Practices for Site Selection and Study Startup
Key strategies for successful research study startup: site selection, documentation, and effective initiation.
Reducing Site Burden Throughout Study Startup
Learn strategies to streamline workflows across sites and sponsors, and explore success stories on how to reduce site burden.
Decentralized Clinical Trials and Regulatory Changes
We discuss the evolution of decentralized trial modalities and possible solutions to regulatory challenges.
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.