Sponsors
Beginner’s Guide to Single IRB Mandates
More governing bodies are starting to opt for single institutional review board (sIRB) review as a way to streamline research operations.
Why Keep HIPAA Separate from the Informed Consent Form
HIPAA is important to the informed consent process, and oftentimes, a standalone document is the most beneficial approach.
Regulatory Trends in Cell and Gene Therapies
Recent signals have indicated the FDA plans to provide greater support for cell and gene therapy research.
Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials
Until the 1980s, children were excluded from research studies. Now, FDA provides draft guidance on ethically including kids in trials.
FDA’s September 2022 NPRMs: What They Mean for Academia and Industry
FDA’s new NPRMs would harmonize certain IRB regulations with the HHS Common Rule. Find out what this could mean for sites and sponsors.
My Favorite Case Study: Patient Centricity in Research
We discuss patient-centric strategies at CSL Behring to improve the patient experience and retention in clinical trials.
Modernizing Site Feasibility and Selection
An important decision impacting a multi-faceted study startup process is determining which sites to partner with for study conduct.
Unpacking IRB Innovations for Decentralized Clinical Trials
Ethical oversight committees continue to innovate to keep pace with the rapid changes and evolution of research conduct.
Advarra Achieves 1,000+ Site Milestone for its Gene Therapy Ready Network
Research involving gene therapy-based treatments can start more quickly with Advarra’s growing network of registered research sites.
Strategies for Successful Site Selection in Clinical Trials
While clinical trial site selection aids in a trial’s success, it’s critical to maximize the study's time, resources, and funds.
Inspection Readiness: Before. During. After
This webinar will cover successful strategies for a proactive approach to FDA inspections before, during, and after.
Streamline Study Startup with Improved Site Selection & Feasibility
Identifying the best prepared and performing sites for a study is essential to success. Explore strategies to improve site selection and feasibility.
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