SAE Reporting and the IRB: Adverse Events in Drug Studies
Explore the basics of SAE reporting to the IRB for drug studies. Learn about reportable events, FDA regulations and guidelines, and how to assess AEs.
sIRB Review for Multicenter Research: A Guide for Institutions
Single IRB (sIRB) review for multicenter research is fast becoming the norm in the US. Initiative such as the NIH sIRB policy and revised Common Rule make it clear that ...
Enhancing User Experience, Security, and Compliance with Single Sign-on
As technology evolves and the industry streamlines research workflows, implementing SSO can lead to significant improvements in both user experience and security.
Navigating sIRB Complexities: An Interactive Session
Join us as we share insights, strategic priorities, and guidance for preparing your institution for sIRB mandates.
Sponsors: Are Your Sites Ready for an FDA Inspection?
Learn a comprehensive overview to prepare sponsors and sites for an FDA inspection.
IRB Review of Changes to Previously Approved Research
Make sure you know the IRB review requirements for amendments involving changes to IRB-approved protocols and other study modifications.
Optimizing Site Initiation Timelines Through Centralized Processes
Learn how to optimize clinical trial initiation with centralized processes, intuitive intake forms, and custom reporting and streamline workflows for efficiency.
mRNA Cancer Vaccines and Therapies: An Overview
Learn about mRNA’s potential impact on cancer research, the technology’s unique challenges, and strategies for researchers developing mRNA-based cancer studies.
Implementing eSource: A Guide for Operations and Technology Roles
Explore the transformative power of eSource in clinical research, streamlining data collection for efficiency and cost savings.
How Sponsors and Sites Work Together to Improve Protocol Compliance
As trials continue to increase in complexities, sites and sponsors must work together to minimize deviations and cause for FDA findings.
Addressing Industry Challenges: Staff Turnover
Staff turnover can greatly impact the quality and progress of an organization’s clinical trials and research projects.