This webinar highlighted best practices in various areas of clinical research management of investigator-initiated trials (IITs) and detailed how to navigate common challenges. The information included in this comprehensive review of IIT operations is experience-based and built upon good clinical research practices in alignment with NIH Regulations.
How the Investigational Drug Services (IDS) Pharmacy utilized by your clinical trials team works shouldn’t be a mystery, when it can instead be one of your biggest allies in research. This webinar provides “insider insights” from an IDS pharmacist on facts you should have at hand about IDS services when sponsors are considering your site for studies, or are sending monitors to keep track of ongoing projects.
How will institutional review boards (IRBs) review study protocols involving the ever-increasing array of mobile health (mHealth) technologies and virtual trial apps on the market? This webinar helps clinical research professionals to understand the regulations and how the oversight of virtual trials might differ from what they have traditionally been used to.
Dive into the key elements of a diversity action plan for Phase III clinical trials, as explained in the latest recommendations and requirements from the U.S. Food and Drug Administration (FDA), including considerations of race, ethnicity, age, sex, gender, geographic location, and socioeconomic status. Learn how these diversity action plans contribute to the study site’s delivery of meaningful data on drug safety and efficacy from to sponsors.
The ICH E8(R1) Guideline on General Considerations for Clinical Studies from the International Council for Harmonization guides the clinical development lifecycle for experimental therapies, including quality requirements for clinical study designs and data sources. Principles and practices for the conduct of clinical trials tied to this guideline, already in effect in such regions as the U.S., Canada, and Europe and forthcoming elsewhere, will be reviewed.