Research Operations
An Evolving Regulatory Environment for Rare and Orphan Diseases
By 1983, only 38 orphan drugs received FDA approval. Since then, the FDA has significantly changed its approach to rare and orphan diseases.
Tips for Accelerating Your Medical Device through the Product Lifecycle
Explore the latest strategies to accelerate your medical device throughout the product development lifecycle.
Advarra Trend Report: Current State of Trial Opportunity and Selection
Insights into the site selection process and the information sites provide as part of site feasibility questionnaire completion.
Enhancing Research Conduct Using eConsent
The Belmont Report established informed consent parameters in 1976, but there are no federal regulations surrounding electronic consent.
Onboarding & Training for Clinical Research Professionals
The webinar will cover strategies for new hires joining the clinical trial industry and key topics to include in your onboarding plan.
Regulatory Considerations for Pharmaceutical Product Lifecycle Management
New FDA guidance (ICH q12) applies to pharmaceutical drug substances and products requiring a marketing authorization.
CBD Research: A Dive into the Regulations of Cannabis Research
With cannabis usage becoming more popular, there’s an uptick in research surrounding its therapeutic effects.
Bridging the Gap: A Standardized Approach to Clinical Trial Document Management
Representatives from the Advarra Site-Sponsor Consortium will discuss a standards-based integration and automation of research technology.
Beyond Pharmaceuticals: Research Involving Cosmetics, Conventional Foods, and Dietary Supplements
Explore regulatory frameworks applicable to research involving cosmetics, conventional foods, and dietary supplements.
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.
Q&A: The IND Journey Phase I – Navigating Success
Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success.
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
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