Gene Therapy Ready Site Network
Advarra’s GTR Site Network includes 1,500+ vetted sites worldwide, fully prepared to support clinical trials in genetic engineering and advanced therapies.
Reviews
Diversity, Equity, and Inclusion in Clinical Research
Achieving diversity, equity, and inclusion (DEI) in clinical trials is crucial for producing comprehensive and effective medical research benefitting all
Decentralized Clinical Trials Involving Biologics: Unique Challenges
Join this webinar to learn about FDA insights on DCTs and biologics. Dr. Eisenman discusses biosafety, risks, and key considerations for safe trials.
Preparing Your Action Plan for the FDA sIRB Mandate
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Budgeting for IRB Review: A Guide for HRPP Leadership
At institutional research programs around the U.S., there exists a pervasive myth: internal institutional review board (IRB) reviews are free.
Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research
Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. The European Parliament recently adopted
Conducting Research With CAR T Cells
Conducting Research With CAR T Cells Regulatory and Practical Considerations Having proven successful in trials for blood cancers considered resistant
Single IRB Review: Tips for Sponsors and CROs Working with Institutional Sites
Discover strategies for sponsors and CROs to navigate single IRB mandates, from institutional IRB roles to optimizing compliance and efficiency.
The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering
Recombinant DNA technologies and genetically modified biological agents are being adapted for a wide scope of therapeutic applications, and their
Navigating Local Considerations When Developing sIRB Reliance Policies
Implementing an sIRB process requires addressing unique local considerations, from consent requirements to cultural nuances, ensuring a streamlined yet ethical review process.
Impact of sIRB Mandates on Study Teams
As sIRB mandates reshape the clinical trial landscape, study teams must navigate unique challenges while ensuring compliance and participant protection.
CAR T Manufacturing and Toxicity
CAR T Manufacturing and Toxicity Pre-Clinical Considerations Genetically engineered therapeutics present diverse, and sometimes heightened, risks compared to traditional small