Featured Articles

1. Improving Collaboration And Accelerating Clinical Research 11/15/2024

   This survey explores how the complexity of clinical research has increasingly challenged the dynamics among research sites, sponsors, and contract research organizations (CROs).

2. Understanding How To Build And Leverage A DSMB Statistical Plan 7/23/2024

   Get an overview of the essential components involved in providing independent statistical center support for a data safety monitoring board (DSMB), also known as a data monitoring committee (DMC).

3. Reporting To The IRB: Unanticipated Device Effects In Medical Device Studies 7/16/2024

   Explore key differences in regulatory requirements for medical device studies compared to drug trials, and learn why understanding the unique term UADE is crucial for compliance and safety.

4. The Regulatory Binder Checklist For Clinical Trial Sites 7/16/2024

   By following this checklist, research teams can enhance organizational efficiency, maintain compliance with regulatory standards, and confidently navigate the complexities of documentation management.

5. Impact Of sIRB Mandates On Study Teams 6/17/2024

   Explore the practical implications faced by investigators and their support staff, such as navigating new bureaucratic procedures and adhering to revised regulatory requirements.

6. Hazard Communications In Studies Involving Genetic Engineering 6/17/2024

   How can effective hazard communication and SOPs from institutional biosafety committees enhance safety in clinical trials involving rDNA technologies and genetically modified biological agents?

7. GxP Audits Guide For Successful Clinical Trials 6/17/2024

   This step-by-step guide helps sponsors and sites prepare for and navigate the various types of audits required at each stage of the clinical trial process.

8. Navigating Local Considerations When Developing sIRB Reliance Policies 6/17/2024

   Here, the author discusses the importance of training and educating research staff on the sIRB process, fostering a culture of collaboration, and developing mechanisms for monitoring compliance and managing conflicts.

9. Making Good Clinical Practice More Understandable 6/17/2024

   What role does Good Clinical Practice (GCP) play in the clinical research ecosystem and how does it safeguard participant rights, safety, and confidentiality while fostering compliance?

10. Analyzing 1,000+ Study Startup Records For Recruitment Performance 5/17/2024

    This overview highlights real research programs at various stages of the recruitment process and demonstrates the impact of Advarra’s Longboat Platform across multiple therapeutic areas and sponsors.