Advarra Blog

FEATURED Post

Ways to Streamline Informed Consent Process in Clinical Trial Startup

Optimizing the informed consent process is critical for accelerating clinical trial startup while maintaining compliance and participant understanding. This article explores key strategies for streamlining informed consent, including leveraging electronic consent (eConsent) solutions, standardizing templates, and improving collaboration between sponsors, sites, and IRBs. By implementing these best practices, research teams can enhance efficiency, reduce delays, and improve the participant experience in clinical trials.

Read Now
Resource
Info Sheets
Reset
Blog

Navigating Local Considerations When Developing sIRB Reliance Policies

Implementing an sIRB process requires addressing unique local considerations, from consent requirements to cultural nuances,…

Read More
Blog

GxP Audits Guide for Successful Clinical Trials

A robust GxP audit program enhances regulatory compliance by ensuring quality and consistency across investigator…

Read More
Blog

Impact of sIRB Mandates on Study Teams

As sIRB mandates reshape the clinical trial landscape, study teams must navigate unique challenges while…

Read More
Blog

Strategic Training: Navigating Organizational Challenges

Training is crucial for changing employee behavior, but not every issue requires it. Identifying when…

Read More
Blog

Key Items Auditors Look for When Reviewing an Investigator Site File

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial…

Read More
Blog

Planning for Complex Change at Your Organization

The only constant in clinical research is change. Researchers are always innovating, making it a…

Read More
Blog

Interim Staffing: Reinvigorating Your Human Research Protections Program

Interim staffing offers HRPPs specialized expertise, fresh perspectives, and support for accreditation and structural improvements…

Read More
Blog

The Value of Continuity: Program-level Data Safety Monitoring Boards

In the realm of pharmaceutical development, ensuring the safety and efficacy of new treatments is…

Read More
Blog

Understanding FDA’s 2024 Draft Guidance on DMCs

The FDA's 2024 draft guidance emphasizes the critical role of independent DMCs in clinical trials,…

Read More
Blog

Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies

In this blog, we’ll take a look at what the regulations do and do not…

Read More
Blog

Reporting to the IRB: Investigator Noncompliance

We often get questions about exactly what events should be reported to the IRB. We…

Read More
Blog

SAE Reporting and the IRB: Adverse Events in Drug Studies

Assessing and reporting adverse events (AEs) in clinical trials is critical to ensuring the study…

Read More

Looking for More?

To register for upcoming webinars and see where we’ll be next, go to the Events page.

Want to see the latest news and updates about Advarra? You can find them in the Newsroom.

Are You Ready To Bring People Together for Better, Faster Trial Outcomes?

Sponsors
Sites
CROs

Subscribe to our monthly email

Receive updates monthly about webinars for CEUs, white papers, podcasts, and more.

Subscribe
Scroll to Top