The Must-Haves of FDA and Common Rule Reporting Requirements
The Food and Drug Administration (FDA) regulations governing Investigational New Drug (IND) applications contain specific reporting requirements. Similarly, the Common Rule (i.e., the federal policy for the protection of human…
Build a Better Budget: Using Medicare Coverage Analysis to Streamline Study Startup
Need to improve your study startup timelines? Consider adding a Medicare Coverage Analysis (MCA) to your toolkit. By leveraging an MCA when building your clinical trial budget template, you can…
The New Urgency of Clinical Trials: How Oncology Leads the Evolution
Join colleagues from the research community for a discussion on the evolution of clinical trials and how oncology research has influenced agility in clinical trial design.
From Reactive to Proactive: How to Evolve Your Research Program During a Global Crisis
Many research programs are evaluating how to keep research moving forward in the face of critical staff shortages and budget limitations—during the COVID-19 pandemic and beyond. Sites are busier than…
Institutional Perspectives: Leveraging Technology to Meet Operational Goals During COVID-19
The COVID-19 pandemic ushered in a myriad of changes for clinical research professionals. One of the most impactful has been the immediate shift to remote processes to accommodate both research…
Fireside Chat: The Future of Clinical Trials and Site Engagement
The COVID-19 pandemic has proven that research can be done more efficiently. To make these efficiencies sustainable, the sites’ perspective must be considered. Sponsors, CROs, and sites should engage early…
Accelerating the Recovery – IRB Review of Virtual Trial Technology
As the research community evolves to address the new normal, sponsors and investigators are rushing to incorporate mobile medical applications and other virtual trial technologies into their research. Is your…
COVID-19 Lessons Learned: Technology and Agility in the New Clinical Trial Landscape
Clinical trials research was forced to evolve and embrace technology in the wake of the COVID-19 pandemic. This unprecedented crisis created a necessary disruption in the use of technology to…
Virtual Symposium: Gene Therapy Research in the Age of COVID-19
Gene therapy research is expanding rapidly in the clinical setting, especially in oncology, rare diseases, and infectious diseases—in fact, gene therapy research plays a crucial role in responding to the…
The New Normal: Considerations for Restarting Research
Throughout the COVID-19 pandemic, we have continually heard what the “new normal” could mean for our work lives, social lives, schools, communities, and our medical system. But what does it…