Planned Emergency Research and Exception from Informed Consent
Explore the regulatory criteria and ethical considerations for planned emergency research, including exceptions from informed consent (EFIC).
Explore the regulatory criteria and ethical considerations for planned emergency research, including exceptions from informed consent (EFIC).
Many research professionals do not realize that there are several different types of institutional review board (IRB) review. A study’s
The report provides information based on surveys and interviews with organizational leaders from top U.S. biotech and pharmaceutical companies.
This white paper outlines key elements of a CDP, including Treatment population, Demonstration of efficacy, Demonstration of safety, Clinical supplies, and Timing of activities.
This white paper outlines key elements of a CDP, including Treatment population, Demonstration of efficacy, Demonstration of safety, Clinical supplies, and Timing of activities.
Learn the essentials of IRB reporting, including why it matters, what’s required, what’s not, and tips to avoid common reporting challenges.
This eBook outlines several challenges you may face as you conduct research, and how a clinical trial management system (CTMS) can address them.
Learn what events need to be reported to the IRB after study approval and explore scenarios to help evaluate potentially reportable events.
Expert assistance from Advarra’s regulatory consulting team enabled iSpecimen to implement GDPR with no service interruption to their Eurozone customers.
Learn proactive strategies to overcome site-sponsor challenges and streamline processes for more successful clinical trial partnerships.
Learn how Duke University streamlined clinical operations with Advarra eReg, improving site-centric workflows and reducing administrative burdens.
About the Advarra In Conversations With… The future of healthcare innovation hinges on research and clinical trials. Advarra sits down