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The Next Generation of CIRBI, the Technology Powering Advarra’s IRB

For more than 40 years, Advarra’s institutional review board (IRB) has been built on a simple commitment: quality, clarity, and care in every review. That commitment hasn’t changed, and it never will. What does change—what has to change—is how we deliver on it. The research community moves faster every year, and the sponsors, sites, and CROs we serve deserve oversight that is as thoughtful and rigorous as it has always been, paired with the speed, expertise, and transparency that modern research demands.

What Is the Difference Between an SAE, AE, and UADE in Clinical Trials? 

Adverse events (AEs) are untoward medical occurrences in participants receiving a study intervention, regardless of…

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Q&A with Advarra’s Senior Coordinator of Client Services Rachel Garrett 

Rachel Garrett’s career in clinical research has come full circle. After starting her journey at…

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Businessman cooperating with doctors in the hospital.

What Is the Difference Between Monitoring and Auditing in Clinical Trials And Why Do They Matter for Inspection Readiness?

Clinical trial monitoring (CTM) and auditing are both essential quality management activities, but they serve…

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Advarra AI Council Members Participate in a Panel at Northwestern University to Discuss the Impacts of AI on Biosecurity

What impact will advancements in artificial intelligence (AI) have on national security and global public…

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The Data Monitoring Committee Charter Is Now a Strategic Governance Document 

FDA’s 2024 draft guidance signals broader expectations for data monitoring committee (DMC) independence, communication, documentation, and sponsor decision-making. For sponsors…

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Why IRBs Ask for Certified Translations of Informed Consent Forms: Regulation, Guidance, and Practical Reality 

Understanding the regulatory foundation behind translated informed consent documents and why many institutional review boards (IRBs) require…

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How Integrated IRB and IBC Administration Facilitate a New Era of Interventional Genetic Therapeutics 

Gene therapies and gene-based therapeutics are giving way to a new era of interventional genetics. Integrated ethics review and…

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Photo of real female scientists researching in laboratory.

The Heart’s Broken Blueprint: Rewriting the Cardiovascular Playbook with Gene Therapy 

Cardiovascular disease remains a worldwide challenge, causing undue strain on the health system and contributing substantial patient burden. For decades,…

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Why Do Clinical Trial Startup Delays Still Happen Despite More Technology? 

Clinical trial study startup has become increasingly technology-enabled, yet sponsors, contract research organizations (CROs), and…

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Rethinking Site Training: A Risk-based Model of Reuse and Reciprocity

Clinical trial site training is supposed to do one essential thing: Prepare site staff to…

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How Amendment Intelligence Helps Reduce Avoidable Protocol Revisions

Clinical development teams can use operational and institutional review board (IRB) data to identify protocol-design…

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Improving Clinical Trial Site Collaboration with Connected Study Startup Workflows 

Clinical trial study startup requires constant coordination across sponsors, contract research organizations (CROs), research sites,…

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