How do remote visits and data collection impact participant monitoring? What techniques will satisfy the regulatory obligation to conduct safety and data monitoring in this new remote research world?
Maintaining complete, compliant documentation during a trial can be challenging. ISFs help ensure ICH E6 (R2) section 8 are met by checking the content of a variety of documents.
Fireside Chats, a new virtual series presented by Advarra, launches this month, bringing the research community together to discuss challenges and potential solutions.
In a recent webinar, Advarra IRB and research compliance experts discussed key areas to consider when ramping up research in the COVID-19 pandemic’s “new normal.”
Q&A: Gene Therapy Research in the Age of COVID-19: Study Startup for Infectious Disease, Oncology, and Rare Disease Research
In Advarra’s inaugural virtual symposium, experts from industry and academia met to discuss the unique challenges gene therapy research poses for research sites, sponsors, CROs, and study participants.
On June 3, members of the research community gathered virtually to discuss updates on hot topics and emerging issues in gene therapy.
Biosafety has surged to the spotlight due to the current COVID-19 global pandemic, motivating sites to conduct a risk assessment and develop a risk mitigation plan.