When Do Clinical Trials of mRNA Products Fall Under IBC Review
Discover how AI and analytics are transforming clinical trial operations, from study startup to accrual workflows, in this insightful whitepaper.
Reviews
Sponsor’s Guide to IRB Approval (Part II): How to Draft a Clinical Trial Protocol That Stands Up to IRB Scrutiny
A strong clinical trial protocol does more than describe how a study will run. It also helps reviewers understand why
Sponsor’s Guide to IRB Approval: What Every Sponsor Needs to Know Before Submitting a Study
Introducing the “‘Sponsor’s Guide to IRB Approval’“ Institutional review board (IRB) approval protects the rights, safety, and welfare of research participants, and
How Sponsors Can Use Adaptive and Platform Trial Models to Reduce Amendments and Accelerate Study Start-Up
Traditional clinical trial designs often delay progress due to rigid protocols and frequent amendments. Adaptive and platform trial models introduce flexibility and shared infrastructure, reducing startup delays, cutting costs, and enabling sponsors to conduct faster, more efficient research.
Enabling Oncology Site Success: Overcoming Administrative and Operational Barriers to Advance Cancer Research
In this webinar, leaders from cancer centers and biopharma companies will discuss the operational and institutional hurdles sites face and what can be done to address them. The panel will explore practical strategies to reduce burden, improve collaboration, and create a better experience for research staff and patients alike.
The Executive Order that Brings Private Bioresearch Under Federal Oversight
The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. More than a revision, E6(R3) marks a shift from traditional practices—making participant safety and data reliability not just priorities, but design drivers, and introducing risk-based proportionality as a foundational approach.
From Ethics to Evidence: Applying Real-World Data in Oncology Trials
Join experts from Johnson & Johnson Innovative Medicine, Bayer, The START Center for Cancer Care, and Advarra to discuss the ethical use of real-world data in clinical research.
Q&A with Advarra’s new Senior Vice President, FDA Regulatory Advisor, Jan Hewett
Clinical research drives medical progress. Advarra ensures participant safety and ethical standards through expert IRB oversight for life-changing therapies.
Making Just-in-Time Oncology Trials Work: Overcoming Barriers and Unlocking Potential
Making Just-in-Time Oncology Trials Work: Overcoming Barriers and Unlocking Potential As part of Oncology Research Pulse, our new thought leadership
An Interview with Jim Kremidas: What’s Next for the Association of Multisite Research Corporations (AMRC)
Launched in January 2025, the Association of Multisite Research Corporations (AMRC) was set up by its founding members to advance
Current State of Site-Sponsor-CRO Collaboration
Our webinar discusses key near-term trends and regulations and investigate persistent challenges frequently throwing even the most efficient teams off track. Advarra and industry representatives will dive deeper into achieving critical milestones across study startup, conduct, and close out that every project manager should optimize.
Ways to Streamline Informed Consent Process in Clinical Trial Startup
At a busy research site, a clinical trial is ready to launch — but it’s stuck in limbo over a