Research Operations
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
The Revolving Door of Research: The Resourceful Way to Run Trials
Examine the current state of industry resources, resourcing implications, and the way we can now think of work: remote, hybrid, or on-site.
Developing an Enterprise Roadmap to Post Authorization Safety Studies
Learn how an organization achieved organization-wide compliance and managed its post-authorization safety studies.
Top Barriers to Participation in Clinical Trials
Understanding the factors that influence the decision to participate in a study helps research professionals diagnose enrollment problems.
Return of Research Results to Study Participants
Research into participant experiences has consistently shown their desire to learn the results of research to which they’ve contributed.
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