How the IND 30-day Hold Impacts Clinical Trial Activities
Find out what research activities can and cannot be conducted during the Investigational New Drug (IND) 30-day hold period.
A Guide for Successful Cell and Gene Therapy Research
Understand the unique regulatory, clinical, and manufacturing requirements for cell and gene therapy research.
Your Guide to sIRB Mandates
This webinar offers insights to your pressing questions related to single IRBs and explores the key features of federal sIRB mandates.
Tips for Accelerating Your Medical Device through the Product Lifecycle
Explore the latest strategies to accelerate your medical device throughout the product development lifecycle.
5 Questions to Ask Your Sponsor for DCT Implementation
Sponsors are uncertain about how to design a DCT to ensure efficient performance delivery, learn how to set your organization up for success.
Beyond Pharmaceuticals: Research Involving Cosmetics, Conventional Foods, and Dietary Supplements
Explore regulatory frameworks applicable to research involving cosmetics, conventional foods, and dietary supplements.
What is an sIRB and Why Does my Study Need One?
Federal requirements have shifted to require most multisite clinical trials to rely on a single IRB for trial oversight.
Regulatory Pathways: When to Follow a 505(b)(2) or an ANDA
Critical insights and key considerations for selecting the best regulatory pathway to ensure success for new drug application submissions.
Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents
Global & FDA regulations dictate how researchers organize & store trial documents. Learn the basics of eTMF & eISF clinical research tools
IRB Review of Decentralized Trial Technology
Explore the current regulatory landscape governing mHealth and virtual trial applications in clinical research.
Four Questions to Ask When Establishing a Pharmacovigilance Organization
Four common but critical questions for emerging biotech organizations establishing a pharmacovigilance (PV) organization.
A Checklist for Optimizing Clinical Trial Study Startup Activities
This checklist outlines key milestones and considerations for sites and sponsors in the clinical trial study startup process.