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FDA’s 2024 draft guidance signals broader expectations for data monitoring committee (DMC) independence, communication, documentation, and sponsor decision-making.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